JP2011214867A - Measurement apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a battery-driven measurement apparatus for preventing a specimen collected from a biological object from being wasted by a battery exhaustion.SOLUTION: The battery-driven measurement apparatus for accepting the specimen collected from the biological object from the outside, measuring a material possibly existing in the specimen, and implementing multiple stages of measurements as a measurement. The apparatus has: a remaining battery level detecting means 103 for detecting a remaining battery level of a battery 102; a calculating means 80 for calculating the number of the measurement implemented by the remaining battery level detected by the remaining battery level detecting means 103, and calculating which stage is implemented among the plurality of stages in the last measurement among the calculated number of the measurements; and a displaying means 11 for displaying a result calculated by the calculating means 80.

Description

  The present invention relates to a measurement apparatus, and more particularly to a battery-driven measurement apparatus that performs a predetermined measurement on a sample collected from a living body.

  In recent years, a large number of assay devices have been developed that hold a test substance (sample) that may contain a test substance on a carrier, and that can easily and quickly test this test substance using an assay such as immunological measurement. Various devices for in-vitro diagnostics, toxic substances, and the like are also commercially available. As an example of such a device, one utilizing an immunochromatographic method as shown in Patent Document 1 can be cited. In the case of using a device utilizing the immunochromatography method, after the sample solution is held on the carrier, if it is fast, the measurement result can be obtained only by standing for about 5 to 10 minutes. Therefore, a measurement technique using an assay method such as immunological measurement has been widely adopted as a simple and rapid measurement technique, for example, in clinical examinations in hospitals or laboratory tests in laboratories.

  In particular, in clinical settings such as clinics, clinics, home medical care, etc., immunochromatographic measurement devices (immunochromatography readers) are used as POCT (Point of Care Testing) measuring devices for simple testing regardless of clinical laboratory specialists. ) Is often used. This immunochromatographic measuring apparatus measures the coloration state of the reagent of the loaded device with high sensitivity, and enables high-sensitivity and highly reliable inspection even in a low coloration state where visual judgment is difficult. . Patent Document 2 shows an example of this type of measuring apparatus.

  In the measurement method as described above, it is required to detect a very small amount of a test substance with high sensitivity. As a measurement method that meets such a requirement, for example, a method for performing sensitization (amplification) shown in Patent Document 3 is known. In this method, after developing a test substance on a carrier, a washing solution is fed to wash away the labeling substance captured by specific binding to the reaction site on the carrier, and then the sensitizing solution is put on the carrier. By sending the solution and sensitizing it, a minute amount of the test substance can be detected with high sensitivity.

  The sensitization process can be performed as necessary. That is, if the coloration state of the reagent can be measured by normal processing, the measurement ends there. If the coloration state cannot be measured by normal processing, the coloration is performed after further sensitization processing. The state may be measured.

JP 2008-139297 A JP 2009-13381 A JP 2009-287952 A

  By the way, measurement apparatuses such as the above-described immunochromatography measurement apparatus may be used in, for example, outdoor diagnosis / inspection sites where commercial power cannot be secured. For this reason, this type of measuring device is often formed to be drivable by a battery (battery).

  Such a battery-powered measuring device may be used to determine, for example, infection or non-infection of an infectious disease. At that time, samples such as blood and oral cells are collected in advance from all the collected subjects. If the sample is collected, there is a possibility that the battery of the measuring device runs out before the diagnosis / inspection for all subjects is completed. When the battery runs out, if the battery is a dry battery (primary battery), it cannot be replenished by purchasing a new battery, etc. If the battery is a secondary battery, it cannot be secured for commercial power for charging. It becomes impossible at all.

  In this way, if the measurement becomes impossible due to battery exhaustion, the collected specimen must be discarded in many cases, resulting in unnecessary physical load on the subject and wasted time. . This is not limited to immunochromatographic measurement devices, but can be generally applied to battery-driven measurement devices that measure a sample collected from a living body.

  In the measurement apparatus configured to perform the above-described sensitization process, the normal process and the sensitization process are combined to perform a total of two stages of measurement. As described above, in a measuring apparatus that performs a plurality of steps in one measurement, even if only a part is performed without performing all the steps in a plurality of steps due to a battery exhaustion, the measurement result has a certain utility value. It may be recognized. Therefore, in such a measurement apparatus that performs measurement in a plurality of stages in one measurement, it is desired to precisely grasp up to which stage the measurement can be performed according to the residual power amount of the battery.

  The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a battery-driven measurement device that can prevent a sample collected from a living body from being wasted due to a battery exhaustion. To do.

The measuring device according to the present invention comprises:
As described above, a sample collected from a living body is received from the outside, a measurement related to a material that may exist in the sample is performed, and a plurality of measurements are performed as one measurement. In a measurement device driven by a battery,
Battery remaining amount detecting means for detecting the remaining power amount of the battery;
The number of measurements that can be performed is calculated based on the amount of residual power detected by the remaining battery level detection means, and regarding the last measurement among the calculated number of measurements, up to which stage of the plurality of stages is measured. An arithmetic means for calculating whether it is executable;
It is characterized by comprising display means for displaying the result calculated by the calculation means.

  Note that, as described above, the measuring apparatus of the present invention is assumed to be configured to perform a plurality of steps as a single measurement. However, in the present invention, only a part of the steps is used. However, if it can be measured, this shall be defined as a “one-time” measurement.

  According to the measuring apparatus of the present invention, the remaining battery power detecting means for detecting the remaining power amount of the battery, the calculating means for calculating the number of measurements that can be performed by the remaining power amount detected by the remaining battery power detecting means, By providing a display means for displaying the result calculated by this calculation means, the equipment user such as an inspection engineer grasps the number of measurements that can be performed from now on at the next point where the display is made. It becomes possible. Therefore, it is possible to know in advance how many (how many) samples can be collected from subjects such as humans, so that it is possible to prevent a situation where samples are wasted and discarded. Become. Thereby, the subject is not subjected to useless physical load and time is not wasted.

  In the measuring apparatus according to the present invention, the calculation unit calculates, to the last measurement among the calculated number of measurements, up to which stage of the plurality of stages can be measured. Since it is configured, the following effects can be obtained. In other words, considering the above-described measurement in a plurality of stages, there are many cases where there are some meaningful measurements even if the measurement is performed halfway without performing all of them. For example, a measurement in which an extremely accurate measurement can be performed if all stages are completed, but a certain level of accuracy can be ensured even in the middle stage. In such a case, the last measurement out of the number of measurements calculated to be feasible, especially if a sample is taken from a subject for whom an urgent measurement is desired, and the measurement for that sample is relatively low even if the accuracy is relatively low. This makes it possible to operate flexibly, such as completing the process.

The perspective view which shows the measuring apparatus by one Embodiment of this invention. Partially cutaway side view of the measuring device Block diagram showing the electrical configuration of the measuring device Front view showing a part of the measuring device Partially cutaway plan view showing one state of the inspection kit used in the measuring apparatus Partially broken plan view showing another state of the inspection kit Partially cutaway plan view showing still another state of the inspection kit Graph showing the relationship between battery power consumption and terminal voltage The graph which shows the example of change characteristic of the battery residual electric energy in the measuring device The partially broken front view which shows the principal part of the measuring apparatus by another embodiment of this invention The partially broken front view which shows the place where the principal part displayed on FIG. 10 is in another state

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. FIG. 1 is a perspective view of a chromatograph measuring apparatus 1 according to an embodiment of the present invention, FIG. 2 is a partially broken side view thereof, and FIG. 3 is an electrical configuration thereof. First, the basic configuration of the present apparatus will be described with reference to FIGS.

  As shown in these drawings, the chromatographic measurement apparatus 1 includes a housing 10 having an opening 10a on the front surface, a display unit 11 disposed on the top surface of the housing 10, and a menu displayed on the display unit 11. An operation unit 12 for performing an operation, a power switch 13, and a test kit loading unit 14 for loading an immunochromatography test kit 20 inside the apparatus are provided. Further, inside the housing 10, a rail 15 that guides the test kit loading unit 14 so as to be movable in the left-right direction in FIG. 2 and a pressing unit for crushing a cleaning liquid pot 27 and a sensitizing liquid pot 28 described later, respectively. 30 and 34, and a first measurement unit 40 and a second measurement unit 50 that acquire information from the test kit 20.

  The inspection kit loading unit 14 is movable along the rail 15 automatically or manually. When most of the sample passes through the opening 10a and is taken out of the housing 10, the test kit 20 supplied with the test solution is placed thereon as described below. Thereafter, the test kit loading unit 14 is pushed into the housing 10 as shown in FIG. 2, whereby the test kit 20 is taken into the chromatograph measuring apparatus 1.

  FIG. 4 is a front view showing a state where the pressing portions 30 and 34 are viewed from the left side in FIG. Here, the inspection kit 20 is shown in a broken state. Hereinafter, the pressing portions 30 and 34 will be described with reference to FIG. The pressing portion 30 includes an arm 31 that is rotatable around a shaft 31 a like a seesaw, a pressing piece 32 that is fixed to a lower end of the arm 31, and a cam that is disposed below the rear end of the arm 31. 33. The cam 33 is connected to a drive shaft 39 rotated by a motor 38 so as to be freely connected and disconnected via an electromagnetic clutch (not shown), for example. When the cam 33 rotates, the rear end of the arm 31 is pushed up, and the pressing piece 32 at the tip moves downward. The other pressing portion 34 also has an arm 35, a pressing piece 36, and a cam 37 and is configured in the same manner as the pressing portion 30.

  Here, the pressing piece 32 of the pressing portion 30 and the pressing piece 36 of the pressing portion 34 are respectively a cleaning liquid pot 27 disposed inside the kit when the inspection kit 20 is disposed at a predetermined position in the housing 10. It arrange | positions so that it may come to the position right above the sensitizing liquid pot 28. FIG.

  FIG. 5 is a plan view showing the inspection kit 20 with the upper surface portion cut away. Hereinafter, the inspection kit 20 will be described with reference to FIG. The test kit 20 is formed on the upper surface of the case so as to inject the sample solution into the insoluble carrier 21, the insoluble carrier 21 having the test line A, the test line B, and the control line C, the kit case 22 that contains the insoluble carrier 21. And an observation window 24 for observing the inspection site of the insoluble carrier 21 (the portions of the test lines A and B and the control line C). An information display unit 25 is provided on the upper surface of the kit case 22. Note that the inspection kit loading section 14 is also provided with an observation window 14a that substantially matches the observation window 24.

  The insoluble carrier 21 has an immobilized labeling substance. The test lines A and B are each fixed with a specific binding substance for the test substance, and the control line C is for judging the end of the measurement.

  In addition, an insoluble carrier 72 for liquid feeding and an insoluble carrier 73 for absorption are disposed inside the test kit 20 with the insoluble carrier 21 sandwiched therebetween. The cleaning liquid pot 27 is fixed above the insoluble carrier 72 for feeding liquid, and the sensitizing liquid pot 28 is fixed above the end of the insoluble carrier 21 on the control line C side. The upper surface portion of the case 22 of the inspection kit 20 is easily deformed to allow the cleaning liquid pot 27 and the sensitizing liquid pot 28 to be crushed when pressed from above by the pressing pieces 32 and 36, respectively. It has become.

  The first measurement unit 40 measures the coloration state of the inspection site (the portions of the test lines A and B and the control line C) through the observation window 24 of the inspection kit 20. As shown in FIG. 2, the first measurement unit 40 includes a camera 42 and a light source 44, and when the inspection kit 20 is loaded into the measurement apparatus 1, these face the observation window 24 from below the inspection kit 20. It is configured as follows. Then, based on the optical information on the examination site acquired by the first measurement unit 40, the optical density and chromaticity are calculated as the coloration state of the examination site (this will be described later).

Note the optical density, the intensity of light incident on the test site of the test kit 20 I, when the intensity of the reflected light from the test site was a I _r, is defined by the following equation.

Optical density = −log ₁₀ (I _r / I)
The chromaticity is a numerical display of hue and saturation, and is calculated from RGB luminance signals read by the camera. As a chromaticity color system, a general CIE color system can be used.

  The camera 42 has, for example, a configuration in which a plurality of photodiodes are arranged in a line or an image sensor including an area sensor, and generates an output corresponding to the amount of received light. The light receiving range of the camera 42 is a band-like range extending in the longitudinal direction of the inspection kit 20. The light source 44 is a module in which, for example, an LED is built, and is configured to emit white light. The light source 44 may emit, for example, monochromatic light as long as the chromaticity before and after the sensitization process described later can be distinguished. When the light source 44 is composed of a plurality of modules, the light source 44 can also be composed of a plurality of modules that emit monochromatic light of different wavelengths. The light emitted from the light source 44 can illuminate a predetermined range in the longitudinal direction of the inspection kit 20.

  On the other hand, the second measurement unit 50 irradiates the information display unit 25 of the test kit 20 with illumination light, and acquires information displayed on the information display unit 25. The information display unit 25 displays information related to the inspection by handwriting or sticker attachment. Information related to testing includes, for example, information related to the patient from whom the test substance was collected (name, age, gender, etc.) and information related to the sample / reagent used in the test (test substance, cleaning solution, sensitizing solution, etc. to be tested) Name). The method for acquiring information is not particularly limited, and the information display unit 25 can be imaged as it is or read from bar-coded information.

  As shown in FIG. 2, the second measurement unit 50 includes a camera 52 and a light source 54. When the inspection kit 20 is loaded into the measurement apparatus 1, these are displayed on the information display unit 25 from above the inspection kit 20. It is comprised so that it may oppose. And the information regarding the test | inspection acquired by the 2nd measurement part 50 and a test result are linked | related and managed. Specific configurations of the camera 52 and the light source 54 are the same as those of the camera 42 and the light source 44 described above, respectively.

  Next, the electrical configuration of this apparatus will be described with reference to FIG. The operations of the pressing mechanisms 30 and 34 and the cameras 42 and 52 (including the light sources 44 and 54, respectively) including the display unit 11, the operation unit 12, and the motor 38 described above are controlled by the control unit 80 shown in FIG. The The measuring apparatus 1 can be operated using, for example, a commercial power source of 100 to 240 V, and the power source unit 100 that receives the commercial power source and converts it into a DC current of 12 V, and the DC current of 12 V are input. Switching unit 101. In addition, the measurement apparatus 1 can be driven by a battery 102 that is a secondary battery, and the battery 102 is also connected to the switching unit 101. The switching unit 101 receives a 12V DC current supplied from the power supply unit 100 when the commercial power supply is connected, and a 12V DC current supplied from the battery 102 when the commercial power supply is not connected. Switch to use in parts.

  In addition, a battery capacity monitoring unit 103 is connected to the switching unit 101 as battery remaining amount detecting means for detecting the remaining power amount of the battery 102. In general, the power consumption when a constant power is taken out from the battery has a relationship as shown in FIG. 8 with the battery terminal voltage. In other words, because of the chemical characteristics of the battery, when the capacity decreases, the internal resistance increases and the terminal voltage decreases. Therefore, the residual electric energy can be detected by measuring the terminal voltage. The battery capacity monitoring unit 103 thus continues to detect the remaining power amount of the battery 102 and inputs a signal indicating the remaining power amount to the control unit 80.

  Next, the measurement by the measuring apparatus 1 of this embodiment is demonstrated. In principle, the apparatus performs a first stage measurement followed by a second stage measurement. The first-stage measurement is to measure the coloration state of the inspection site without performing a sensitization process described later, and the second-stage measurement is an inspection after performing a sensitization process described later. The color state of the part is measured.

  The power consumed by the apparatus 1 when performing such measurement includes the following three types. (1) Power consumption under normal standby state: This is the power that is continuously consumed in the display unit 11, the operation unit 12, the control unit 80, etc. when the power is turned on. And are consumed together in the second stage measurement. Hereinafter, regarding the power consumption, the former power consumption is referred to as “normal 1” power consumption, and the latter power consumption is referred to as “normal 2” power consumption.

(2) Consumption for acquiring the image of the examination site with the camera: This is also consumed for the first stage measurement and the second stage measurement. Hereinafter, these power consumptions are for the former. The power consumption of “image acquisition 1” is referred to as the power consumption of “image acquisition 2”.

(3) Power consumption for operating the pressing mechanisms 30 and 34 when performing the sensitization processing: This power consumption is hereinafter referred to as power consumption of “sensitization processing pressing mechanism operation”.

  Next, a specific measurement operation procedure will be described.

<< First stage measurement >>
In the first-stage measurement, first, as shown in FIG. 5, for example, the sample solution 90 is injected from the solution injection port 23 of the test kit 20 outside the measuring apparatus 1. Thereafter, this test kit 20 is arranged in the measuring apparatus 1 as described above, and in order to calculate the optical density and chromaticity of the test site (test lines A, B and control line C) of the test kit 20, An image of the part is acquired by the camera 42. The control unit 80 can calculate the optical density and chromaticity from the image thus obtained, and can display the values or the presence or absence of a disease determined from the values on the display unit 11.

The power consumed in the first stage measurement is 2.5 W × 10 minutes = 0.42 Wh because the “normal 1” takes 10 minutes per measurement, and the “image acquisition 1” Since imaging is performed 60 times per second per measurement, 2.5 W × 1 second × 60 times = 0.04 Wh. That is, the total power consumed in the first stage measurement is 0.46 Wh. The above is summarized in Table 1 below.

<< 2nd stage measurement >>
In the second stage measurement, first, the pressing portion 30 shown in FIGS. 2 and 4 is driven, the tip of the arm 31 is moved downward, and the pressing piece 32 moves the cleaning liquid pot 27 in the inspection kit 20 from the outside. Crush. As a result, as shown in FIG. 6, the cleaning liquid 91 stored in the cleaning liquid pot 27 cleans the inspection site of the insoluble carrier 21. At this time, the washing liquid 91 is sufficiently spread by the insoluble carrier 72 for liquid feeding, and then fed in the order of the insoluble carrier 21 and the insoluble carrier 73 for absorption.

  Next, the pressing portion 34 shown in FIGS. 2 and 4 is driven, the tip of the arm 35 is moved downward, and the pressing piece 36 crushes the sensitizing solution pot 28 in the test kit 20 from the outside. As a result, as shown in FIG. 7, the sensitizing solution 92 stored in the sensitizing solution pot 28 is sent to the inspection site of the insoluble carrier 21 to be sensitized. The sensitizing liquid 92 and the cleaning liquid 91 are disclosed in detail in the above-mentioned Patent Document 3, and can be applied to the present invention.

  After this sensitization processing is performed, an image of the inspection site of the inspection kit 20 is acquired by the camera 42 as described above. The control unit 80 can calculate the optical density and chromaticity of the image thus obtained, and can display the values, or the presence or absence of a disease determined from the values, on the display unit 11.

The power consumed in the second stage measurement is 2.5 W × 5 minutes = 0.21 Wh because the “normal 2” takes 5 minutes per measurement, and the “image acquisition 2” Since imaging is performed 30 times per second per measurement, 2.5 W × 1 second × 30 times = 0.02 Wh, and the “sensitized processing pressing mechanism operation” is 0.64 Wh. Here, the power consumption of the final “sensitization processing pressing mechanism operation” is 12 W × 2 minutes / 1 case because the operation of the motor 38 for moving the pressing portions 30 and 34 requires 1 minute each for a total of 2 minutes. In addition, after each operation of the motor 38, there is a stop period of 1.5 minutes each for a total of 3 minutes, in which 4.8 W × 3 minutes / case is consumed, so that the sum of these is 0.64 Wh. . That is, the total power consumed in the second stage measurement is 0.87 Wh. The above is summarized in Table 2 below.

  Thus, in this example, 0.46 Wh + 0.87 Wh = 1.33 Wh is consumed to perform one measurement. The control unit 80 shown in FIG. 2 divides the remaining battery power amount notified from the battery capacity monitoring unit 103 by the above 1.33 Wh when the measurement apparatus 1 operates with the battery 102, and calculates the number of measurement cases that can be processed. It is displayed on the display unit 11. And when the remainder in the division is 0.46 Wh or more and less than 0.87 Wh, it is counted and displayed as one measurement is possible. In that case, however, the display 11 is also displayed together with a message such as “The remaining battery level is low and the last one cannot be sensitized. Do you want to measure without sensitization?” Let the device user decide whether or not to measure without processing.

  By confirming the display as described above, the device user can know in advance how many (how many) subjects can collect samples. If so, it is possible to prevent a situation in which the sample is unnecessarily collected and discarded. Thereby, the subject is not subjected to useless physical load and time is not wasted.

  The calculation and display of the number of measurements that can be processed may be performed when starting a series of measurements, or when a series of measurements progresses and the remaining battery level becomes a concern. You may make it carry out suitably by.

  Moreover, according to the measuring apparatus 1 of this embodiment, it can also be known whether measurement without a sensitization process can be performed about the last one measurement. Therefore, it is possible to perform a flexible operation in which a sample is collected from a subject for whom an urgent measurement is desired and the measurement related to the sample is completed even if the accuracy is relatively low.

  Here, FIG. 9 shows the result of actual measurement of the change in the battery residual power amount when the first and second stage measurements are performed in the present embodiment. Note that the power consumption described above is a calculated value when the processing is ideally performed, and the actually measured value shown in FIG. 9 is slightly different from the calculated value.

  Next, with reference to FIG. 10 and FIG. 11, a measuring apparatus according to another embodiment of the present invention will be described. In these drawings, the same elements as those in FIG. 4 are denoted by the same reference numerals, and description thereof will be omitted unless necessary (the same applies hereinafter). In this embodiment, a test kit 20 having a partially different structure from that shown in FIG. 4 is used. That is, in this inspection kit 20, the cleaning liquid pot 27 and the sensitizing liquid pot 28 are disposed on the blades 87 and 88, respectively, and the opening 22a, 22b is provided.

  When the cleaning liquid from the cleaning liquid pot 27 and the sensitizing liquid from the sensitizing liquid pot 28 are allowed to flow out, the cam 33 is rotated 90 ° from the state shown in FIG. 10 to the state shown in FIG. That is, when the cam 33 rotates, the rear end of the arm 31 is pushed up and the tip pressing piece 32 is lowered, and similarly, the rear end of the arm 35 is pushed up and the tip pressing piece 36 is lowered. The pressing pieces 32 and 36 that have moved down pass through the openings 22a and 22b, respectively, and enter the kit case 22 to push down the cleaning liquid pot 27 and the sensitizing liquid pot 28, respectively. Then, the bottoms of the cleaning liquid pot 27 and the sensitizing liquid pot 28 are partially cut by the blades 87 and 88, respectively, so that the cleaning liquid flows from the cleaning liquid pot 27 and the sensitizing liquid flows out from the sensitizing liquid pot 28.

  In the present embodiment having the configuration as described above, if the remaining power amount of the battery 102 becomes zero in the state of FIG. 11, the motor 38 that rotates the cam 33 cannot be driven. The pressing pieces 32 and 36 remain in the openings 22a and 22b, respectively. If so, even if the device loading unit 14 shown in FIGS. 1 and 2 is moved in the device pull-out direction (direction perpendicular to the paper surface of FIGS. 10 and 11), the pressing pieces 32 and 36 have the openings 22a and 22b, respectively. It becomes impossible to move the device loading unit 14 by interfering with the peripheral wall portion of the device. Therefore, in order to take out the inspection kit 20 from the measuring device, troublesome work such as disassembling the measuring device is required.

  Even in the case of the configuration as described above, the present invention calculates and displays the number of measurements that can be performed and up to which of the multiple levels the measurement can be performed with respect to the last measurement. If this is done, it is possible to prevent the measurement kit from being taken out of the measurement apparatus as described above, because it is possible to avoid performing the measurement more than the possible number of times.

  The items related to the measurement will be briefly described below.

(Sample solution)
As long as the sample solution that can be analyzed using the measuring apparatus of the present invention includes a test substance (natural products, toxins, hormones, physiologically active substances such as agrochemicals, environmental pollutants, etc.) For example, biological samples, especially animal (especially human) body fluids (eg blood, serum, plasma, spinal fluid, tears, sweat, urine, pus, runny nose or sputum) ) Or excrement (for example, feces), organs, tissues, mucous membranes and skin, overwhelmed specimens (swabs), gargles, or animals and plants themselves or their dried bodies, which are considered to contain them, are diluted with a diluent described below. Can be mentioned.

  Leave the sample solution as it is, or in the form of an extract obtained by extracting the sample solution with an appropriate extraction solvent, and further dilute this extract with an appropriate diluent. It can be used in the form or the extract concentrated by an appropriate method.

(Labeling substance)
As a labeling substance that can be used in the present invention, metal fine particles (or metal colloids), colored latex particles, enzymes, etc., which are used in general immunochromatography, can be visually confirmed or can be inspected by reaction. It can be used without any particular limitation as long as it is a labeled substance, but when a signal is sensitized by metal deposition on the labeling substance by a reduction reaction of metal ions using the labeling substance as a catalyst, From the viewpoint of catalytic activity, metal fine particles are preferred.

  As the material of the metal fine particles, a metal simple substance, metal sulfide, other metal alloy, or polymer particle label containing metal can be used. The average particle size of the particles (or colloid) is preferably in the range of 1 nm to 10 μm. Here, the average particle diameter is an average value of the diameters of the plurality of particles (the longest diameter of the particles) measured by a transmission electron microscope (TEM). More specifically, gold colloids, silver colloids, platinum colloids, iron colloids, aluminum hydroxide colloids, composite colloids thereof, and the like are preferable. Gold colloids, silver colloids, platinum colloids, and composite composite colloids thereof are preferable. It is desirable to be. In particular, gold colloid and silver colloid are suitable in terms of appropriate particle diameters, and gold colloid is red and silver colloid is yellow, which is more preferable from the viewpoint of high visibility. By using a gold colloid, the sensitization process using a silver ion-containing compound changes the chromaticity of the label before and after the sensitization (the gold colloid is colored red, and after the sensitization, the reduced silver Since the ions are deposited on the gold colloid and become black), this change can be used for error determination of the inspection as will be described later. The average particle size of the metal colloid is preferably about 1 to 500 nm, more preferably 1 to 100 nm.

(Specific binding substance)
The specific binding substance is not particularly limited as long as it has affinity for the test substance. For example, when the test substance is an antigen, an antibody against the antigen, the test substance is a protein, a metal ion Alternatively, aptamers for low molecular weight organic compounds, and when the test substance is a nucleic acid such as DNA or RNA, nucleic acid molecules such as DNA or RNA having a sequence complementary thereto, or the test substance is avidin. In some cases, biotin, and in the case where the test substance is a specific peptide, a complex that specifically binds to this can be used. In the above example, the relationship between the specific binding substance and the test substance can be exchanged. For example, when the test substance is an antibody, an antigen against the antibody can be used as the specific binding substance. Furthermore, a compound or the like partially containing a substance having affinity for the test substance as described above can also be used as the specific binding substance.

  Specific examples of the antibody include antiserum prepared from the serum of an animal immunized with the test substance, an immunoglobulin fraction purified from the antiserum, and cell fusion using spleen cells of the animal immunized with the test substance Or a fragment thereof [for example, F (ab ′) 2, Fab, Fab ′, or Fv] can be used. These antibodies can be prepared by a conventional method.

(Insoluble carrier)
The material of the insoluble carrier 21 is preferably porous. For example, a nitrocellulose membrane, a cellulose membrane, an acetylcellulose membrane, a polysulfone membrane, a polyethersulfone membrane, a nylon membrane, a glass fiber, a nonwoven fabric, a cloth, or a thread is used. Preferably mentioned.

  On the chromatographic carrier, a specific binding substance for the test substance is immobilized, and a test site or a control site is produced if desired. The specific binding substance may be directly immobilized on a part of the chromatographic carrier by physical or chemical binding, or the specific binding substance may be physically or chemically attached to fine particles such as latex particles. The fine particles may be trapped on a part of the chromatographic carrier and immobilized.

(Sensitizer)
The sensitizing solution is a solution capable of causing a signal sensitization by producing a colored or luminescent compound or the like when a contained drug reacts by a catalytic action of a labeling substance or a test substance. For example, a silver ion solution that causes metal silver to be deposited by physical development on a metal label. Details include general books in the field of photographic chemistry (for example, “Basics of Revised Photo Engineering-Silver Salt Photography Edition” (Japan Photographic Society, Corona), “Photochemistry” (Akira Sakurai, Photo Industry Publishing) ), “Latest Prescription Handbook” (Shinichi Kikuchi et al., Amico Publishing Co., Ltd.)), so-called developers can be used. For example, when a physical developer containing a silver ion-containing compound is used as a sensitizer, silver ions in the solution can be reduced mainly by a metal colloid or the like that serves as a development nucleus by a silver ion reducing agent. .

As another example, an enzyme reaction is used. For example, a solution of a phenylenediamine compound and a naphthol compound, which becomes a dye by the action of a peroxidase label and hydrogen peroxide, can be used. Further, it may be a chromogenic substrate for detecting horseradish peroxidase as described in the non-patent document “Staining using clinical test Vol. 41 no. 9 p. 1020 H ₂ O ₂ -POD system”. In addition, the chromogenic substrate described in JP2009-156612A can be particularly preferably used. A system using a metal catalyst such as platinum fine particles instead of the enzyme may be used.

  As an example using another enzyme, there is a system in which alkaline phosphatase is used as a label and color is developed using 5-bromo-4chloro-3-indolyl-phosphate disodium salt (BCIP) as a substrate. As described above, the reaction that gives a color is given as a representative, but any combination of enzyme and substrate, such as those generally used in enzyme immunoassays, may be used, and even a chemiluminescent substrate is a substrate that emits fluorescence. May be.

(Silver ion-containing compound)
As the silver ion-containing compound, an organic silver salt, an inorganic silver salt, or a silver complex can be used. Preferably, it is a silver ion-containing compound having high solubility in a solvent such as water, and examples thereof include silver nitrate, silver acetate, silver lactate, silver butyrate, and silver thiosulfate. Particularly preferred is silver nitrate. The silver complex is preferably a silver complex coordinated to a ligand having a water-soluble group such as a hydroxyl group or a sulfone group, and examples thereof include hydroxythioether silver. The inorganic silver salt or silver complex is generally contained as silver in an amount of 0.001 mol / m ^{2 to} 0.2 mol / m ² , preferably 0.01 mol / m ^{2 to} 0.05 mol / m ^2. preferable.

(Silver ion reducing agent)
As the silver ion reducing agent, any inorganic or organic material or a mixture thereof can be used as long as it can reduce silver ions to silver.

Preferred examples of the inorganic reducing agent include reducible metal salts and reducible metal complex salts whose valence can be changed by metal ions such as Fe ²⁺ , V ²⁺ , and Ti ³⁺ . When using an inorganic reducing agent, it is necessary to complex or reduce the oxidized ions to remove or render them harmless. For example, in a system using Fe ²⁺ as a reducing agent, a complex of Fe ³⁺ that is an oxide can be formed using citric acid or EDTA, and can be rendered harmless. In this system, it is preferable to use such an inorganic reducing agent, and more preferable is a metal salt of Fe ²⁺ .

  In the above-described embodiment, a method of sensitizing a labeling substance by reducing a silver ion-containing compound with a reducing agent is used as a sensitizing method in a colored state, but the sensitizing method in the present invention is limited to this. Not. The sensitizing solution may be any solution that can cause a signal sensitization by generating a colored or luminescent compound by reacting the contained drug by the catalytic action of a labeling substance or a test substance. And liquids using such enzymes.

  Moreover, in the said embodiment, although the immunochromatography method was demonstrated as an assay method, the assay method applied by this invention is not limited to this. A system that does not use a so-called immune reaction may be used, for example, a system that captures a test substance with a nucleic acid such as DNA or RNA without using an antibody, or another small molecule or peptide that has an affinity for the test substance, A system in which a test substance is captured by a protein, a complex-forming substance, or the like may be used.

DESCRIPTION OF SYMBOLS 1 Chromatographic measuring apparatus 10 Case 11 Display part 12 Operation part 13 Power switch 14 Device loading part 20 Immunochromatography test kit 21 Insoluble carrier 22 Kit case 22a, 22b Kit case opening 23 Solution inlet 27 Washing liquid pot 28 Sensitizing liquid Pot 30, 34 Pressing unit 33, 37 Cam 38 Motor 40, 50 Measuring unit 87, 88 Blade 80 Control unit 90 Sample solution 91 Cleaning solution 92 Sensitizing solution 102 Battery 103 Battery capacity monitoring unit A, B Test line C Control line

Claims (2)

A sample collected from a living body is received from the outside, measured on a material that may exist in the sample, and is configured to perform a multi-stage measurement as a single measurement. In the measuring device,
Battery remaining amount detecting means for detecting the remaining power amount of the battery;
The number of measurements that can be performed is calculated based on the amount of residual power detected by the remaining battery level detection means, and regarding the last measurement among the calculated number of measurements, up to which stage of the plurality of stages is measured. An arithmetic means for calculating whether it is executable;
A measuring apparatus comprising display means for displaying a result calculated by the computing means.   2. The measuring apparatus according to claim 1, wherein detection of the remaining power amount by the battery remaining amount detecting means, calculation by the calculating means, and display by the displaying means are performed every time before the measurement. .

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