WO2010058471A1 - 試験具および光学的測定装置 - Google Patents

試験具および光学的測定装置 Download PDF

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Publication number
WO2010058471A1
WO2010058471A1 PCT/JP2008/071138 JP2008071138W WO2010058471A1 WO 2010058471 A1 WO2010058471 A1 WO 2010058471A1 JP 2008071138 W JP2008071138 W JP 2008071138W WO 2010058471 A1 WO2010058471 A1 WO 2010058471A1
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WIPO (PCT)
Prior art keywords
test
reagent
test device
patient
reagent holding
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PCT/JP2008/071138
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English (en)
French (fr)
Japanese (ja)
Inventor
貴司 中川
真也 中嶋
督夫 笠井
Original Assignee
アークレイ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by アークレイ株式会社 filed Critical アークレイ株式会社
Priority to EP08878268A priority Critical patent/EP2367002A4/en
Priority to CN2008800080174A priority patent/CN101790686B/zh
Priority to US12/517,776 priority patent/US8182761B2/en
Priority to PCT/JP2008/071138 priority patent/WO2010058471A1/ja
Publication of WO2010058471A1 publication Critical patent/WO2010058471A1/ja
Priority to US13/455,253 priority patent/US8574511B2/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation

Definitions

  • the present invention relates to a test device used in an optical measurement method, and an optical measurement device that performs an inspection by reading a reagent coloration state of the test device.
  • Patent Document 1 As a testing device for POCT (Point of Care Testing), which is used in clinics, clinics, and home medical settings, regardless of clinical laboratory specialists, urine test paper that has been immersed in urine and pulled up (for example, Patent Document 1), a clinical test apparatus (for example, Patent Document 2) for optically reading a biochemical test piece applied with blood-derived serum or plasma, and a cuvette in which a liquid reagent is enclosed (for example, Patent Many optical measuring devices are used, such as devices for measuring literature 3).
  • POCT Point of Care Testing
  • FIG. 12 shows an example of a conventional optical measuring apparatus (for example, Patent Document 4).
  • the optical measuring device X shown in the figure is loaded with a test tool Y based on a so-called immunochromatograph.
  • the test tool Y is a strip-shaped test piece including a porous carrier 91 having a plurality of reagent holding portions 92 on which reagents (immunological substances, mainly antibodies) are fixed.
  • reagents immunological substances, mainly antibodies
  • FIG. 13 shows the shape of a general urine test paper used by dipping in urine.
  • the test paper 910 shown in the figure has a strip-shaped support 911 and a reagent holding part 912.
  • the reagent holding unit 912 is provided on the support 911, and the reagent is fixed in an impregnated dry state in a carrier made of a porous matrix such as filter paper.
  • a carrier made of a porous matrix such as filter paper.
  • FIG. 14 shows an example of a conventional optical measurement apparatus for measuring not only a urine sample but also a blood-derived serum / plasma sample by a biochemical test piece applied directly to a reagent holding part.
  • a table 922 is provided in the optical measuring device 920 shown in FIG. The table 922 is loaded with a biochemical test piece 921.
  • the carrier in the test piece 921 is composed of a complex of a polymer compound (mainly kneaded material represented by a water-soluble polymer) and a porous film (knitted fabric, nonwoven fabric, etc.) or any one of them, and the reagent holding part is the polymer.
  • a reagent is fixed in a dry state to at least one of the compound and the porous membrane.
  • a liquid sample such as blood or urine as a specimen is directly applied to the reagent holding portion of the test piece 921. Then, this specimen dissolves the polymer compound constituting the carrier or penetrates into the porous film. Then, the sample and the reagent react in the reagent holding unit. The color change of the reagent holding part is observed after a predetermined reaction time.
  • FIG. 15 shows an example of a so-called cuvette type test device.
  • the test device 930 shown in the figure has a plurality of wells 931 and is made of, for example, a light transmissive resin. These wells 931 are used as carriers, and each well 931 in which a reagent is sealed in a liquid or solid state functions as a reagent holding unit.
  • the specimen When the specimen is applied to the designated well 931 of the test device 930, the specimen reacts with the reagent in the well 931. Thereby, after a certain time, the well 931 functioning as the reagent holding unit exhibits a color reaction according to the concentration of the specific component contained in the specimen. This color reaction result can be easily observed from the outside because the well 931 is light-transmissive.
  • the optical measuring device X shown in FIG. 12 will be described as an example.
  • the optical measuring device X includes a light emitting means 93 and a light receiving means 94.
  • an inspection start command is sent to the controller 95, for example, by a user operation.
  • the controller 95 performs a light emission process for causing the light emitting means 93 to emit light, and a light receiving process for receiving the light reflected by the porous carrier 91 including the reagent holding unit 92 by the light receiving means 94.
  • image data of a portion including the reagent holding unit 92 in the porous carrier 91 is accumulated in the controller 95. By analyzing the image data, the presence or absence of a specific component contained in the specimen can be determined according to the color state of the reagent holding unit 92, for example.
  • the test device Y is a urine test paper or biochemical test piece similar to the test paper 910 shown in FIG. 13, the surface of the reagent holding portion 912 (also referred to as a reagent pad) may be used.
  • the reflected light after the reaction between the reagent and the specimen or at the reaction stage is measured by a dedicated device.
  • the test device Y is similar to the cuvette-type test device 930 shown in FIG. 15, the reflected light or transmitted light after the reaction between the reagent in the well and the sample is reflected on the surface of the light transmissive well. Measured through.
  • the inspection result obtained by such optical measurement is output by output means 96 such as a printer.
  • output means 96 such as a printer. The user can easily recognize the presence or absence of a specific component of the specimen from the output result.
  • the present invention has been conceived under the circumstances described above, and it is possible to easily collate test results when performing a test using an optical measurement method for a large number of patients. It is an object of the present invention to provide a simple test tool and an optical measurement device.
  • a test tool provided by the first aspect of the present invention is a test tool having one or more reagent holding parts that hold a reagent that reacts with a specimen and exhibits a color reaction, and is provided in a part of the test tool. Is characterized in that a patient identification information area for entering patient identification information is provided.
  • the sample has a carrier to which the sample is applied, and the one or more reagent holding units are formed of a part of the carrier holding the reagent.
  • the test device is a test piece based on an immunochromatograph
  • the carrier is a porous membrane
  • the reagent holding part is an immunological substance on the porous membrane.
  • the patient specifying information area is provided in a part of the porous membrane.
  • the test device is a test piece based on an immunochromatograph
  • the carrier is a porous membrane
  • the reagent holding part is an immunological substance on the porous membrane.
  • a case having a measurement window that accommodates the carrier and exposes the reagent holding portion, and the patient specifying information area is provided in a part of the case.
  • the test device is a test paper that is immersed in a liquid
  • the carrier is a porous film
  • the reagent holding unit is configured to apply the reagent to the porous film. It is fixed in a dry state, and further includes a support to which the reagent holding unit is fixed, and the patient specifying information area is provided on the support.
  • the test device is a test piece of a type in which a specimen is spotted on the reagent holding portion, and the carrier is composed of at least one of a polymer compound and a porous membrane,
  • the reagent holding part is obtained by fixing the reagent in a dry state to at least one of the polymer compound and the porous membrane, and further includes a support to which the reagent holding part is fixed, The information area is provided on the support.
  • the test device is a light-transmitting cuvette having a plurality of compartments
  • the carrier is a light-transmitting compartment
  • the reagent holding section is provided for each of the compartments.
  • the reagent is sealed in a chamber in liquid or solid form, further includes a seal member that seals the compartment, and the patient specifying information area is provided on the seal member.
  • the test device is a light-transmitting cuvette having a plurality of compartments
  • the carrier is a light-transmitting compartment
  • the reagent holding section is provided for each of the compartments.
  • the reagent is enclosed in a chamber in liquid or solid form, and the patient-specific information area is provided on a side surface of the light-transmitting compartment.
  • the patient-specific information area bulges out from a portion surrounding it.
  • the patient specifying information area is rougher than a portion surrounding the patient specifying information area.
  • the optical measuring device provided by the second aspect of the present invention reads the color state of the reagent holding portion in a state where one or more test devices provided by the first aspect of the present invention are loaded.
  • An optical measurement apparatus comprising: a reading unit; and a control unit that performs drive control and examination processing of the reading unit, wherein the reading unit is configured to be able to read the patient-specific information region, and The means is characterized in that the test result output data is generated using the image data of the patient specific information area obtained by the reading process of the reading means.
  • a printer as an output unit is further provided, and the printer performs printing based on the inspection result output data sent from the control unit.
  • an external connector is further provided as output means, and the control means is configured to transmit the inspection result output data from the external connector.
  • a plurality of the above test devices can be loaded.
  • FIG. 3 is a sectional view taken along line III-III in FIG. 2.
  • FIG. 4 is a sectional view taken along line IV-IV in FIG. 2.
  • FIG. 5 is a cross-sectional view taken along line VV in FIG. 2.
  • It is a whole perspective view which shows an example of the optical measuring device which concerns on this invention.
  • It is a system block diagram which shows the optical measuring apparatus shown in FIG. It is a chart which shows one Example of the test
  • the test device B of this embodiment includes a case 6, a carrier 7, and reagent holding portions 8A, 8B, and 8C to which an immunological substance such as an antibody is fixed.
  • an optical device such as an immunochromatography is used.
  • By being loaded into a measuring device it is used for inspection by an optical measuring method typified by, for example, an immunochromatography method.
  • the test device B is used for influenza testing.
  • the case 6 is constituted by an elongate cover 6A made of white resin, for example, and a base 6B, and accommodates a carrier 7 formed of a porous matrix.
  • the case 6 includes an application unit 61, a measurement window 62, an examination item code 63, and a patient information entry column 64, and a depressed portion 6a and an inclined surface 6b are formed.
  • the application unit 61 is a part where the specimen is applied and is composed of a through hole exposing a portion near one end of the carrier 7 formed in the cover 6A and a crater-like part surrounding the through hole.
  • the measurement window 62 is an elongated through hole provided near the center of the cover 6 ⁇ / b> A, and exposes the reagent holding portions 8 ⁇ / b> A, 8 ⁇ / b> B, 8 ⁇ / b> C formed on the carrier 7.
  • the inspection item code 63 is a portion in which inspection item data that can be inspected by the test tool B is recorded, and is printed as, for example, a barcode (two-dimensional code in the figure).
  • the patient information entry column 64 is an area for handwriting information on a patient to be examined, such as a name, and is an example of a patient specifying information area referred to in the present invention. As shown in FIGS. 2 and 4, in the present embodiment, the patient information entry column 64 is a portion that bulges out in a rectangular plateau shape with respect to the portion surrounding it. As shown in FIG. 5, the surface of the patient information entry column 64 is a so-called textured surface and is rougher than the portion other than the patient information entry column 64. The letters in the figure are handwritten by the patient or the nurse or laboratory technician who is the user using a writing instrument such as a felt pen, for example. Is. In addition, although the patient's name is assumed as the content to be entered in the patient information entry column 64, any other content that can identify the patient, such as an identification number or nickname in the organization to which the patient belongs, may be used.
  • the depressed portion 6a is a portion where the measurement window 62 is formed, and is located closer to the carrier 7 than a portion sandwiching the depressed portion 6a in the longitudinal direction of the case 6 as shown in FIG.
  • the inspection item code 63 is attached to the depressed portion 6 a and is adjacent to the measurement window 62 in the width direction of the case 6.
  • the inclined surface 6 b is formed so as to be connected to the measurement window 62 in the width direction of the case 6. In the present embodiment, the inclined surface 6 b is inclined about 45 degrees with respect to the width direction of the case 6.
  • test device B when the test device B is a urine test paper, it has a support and reagent holding portions 8A and 8B formed on the support.
  • the reagent holding units 8A and 8B are configured as reagent pads in which a reagent is impregnated and dried in a carrier.
  • the reagent holding unit 8A is configured to inspect a plurality of items such as glucose and the reagent holding unit 8B are proteins. Is done. In order to determine what items the test tool B can measure, an inspection item code 63 is printed on the support.
  • each of the compartments (hereinafter referred to as wells) in the cuvette corresponds to the carrier 7, and a liquid or solid reagent is sealed in the well.
  • Each well functions as a reagent holding part 8A, 8B.
  • the inspection item code 63 can be printed on the surface of a seal hermetically sealed with aluminum laminate or the like so that the contents of the well are not leaked.
  • a patient information entry field 64 can be provided on the surface of the seal as an example of a patient specifying information area. Patient information is also provided on the side of a well that is not directly involved in optical measurement, such as a well for holding a pipette tip (the rightmost well in FIG. 15) or a waste fluid well for storing a waste fluid that has been measured.
  • An entry field 64 can be provided.
  • the carrier 7 is a porous member for developing the sample applied from the assay application unit 61 so as to exceed the reagent holding units 8A, 8B, 8C in the test device B based on immunochromatography, For example, a belt-shaped member made of nitrocellulose.
  • the carrier 7 indicates a pad made of at least one of a porous material and a polymer compound impregnated with a reagent, or a well itself constituting the cuvette.
  • the reagent holding portions 8A, 8B, and 8C are portions in which a reagent (an immunological substance such as an antibody) is fixed to the carrier 7 in this embodiment using an immunochromatograph as an example.
  • the reagent holding portions 8A and 8B are made by fixing a reagent for determining whether positive or negative in an influenza test, for example, in a linear shape extending in the width direction of the carrier 7, and are generally called test lines.
  • the reagent holders 8A and 8B can be arbitrarily added according to the measurement target. Although it is often referred to as a test line for convenience, it may be fixed in a spot rather than a line.
  • the reagent holding part 8A itself is a reagent pad for detecting one item. For example, if there are ten reagent holding parts, the urine test paper has ten items in principle. Can be measured.
  • the reagent holding unit 8C is used to determine that the sample has passed through the reagent holding units 8A and 8B, which are test lines, and is generally called a control line.
  • the reagent holding unit 8 ⁇ / b> C is formed by fixing a reagent that develops color by reacting with a specimen in a linear shape extending in the width direction of the carrier 7.
  • the reagent holding unit 8C is a control that does not contain any reagent for optically canceling the influence of, for example, dark colored urine or hemolysis when taking a medicine. It can also serve as a pad or control well.
  • the optical measuring apparatus A of this embodiment includes a case 1, a reading unit 2, a controller 3, a printer 4, and an external connector 5, and an immunochromatography method by reading the coloration state of the loaded test device B. It is possible to perform an inspection using In FIG. 7, case 1 is omitted for the sake of understanding.
  • the case 1 of the optical measuring device A is made of, for example, resin or metal, and is a reading unit 2, a controller 3, a printer 4, and an external connector 5 that are other components of the optical measuring device A. Is housed.
  • the case 1 is formed with a loading portion 11.
  • the loading unit 11 is a part for loading the test tool B to which the sample is applied.
  • the loading unit 11 is divided into CH1 to CH6, and six test devices B can be loaded at an arbitrary timing and number.
  • a plurality of LED lamps are provided immediately above the loading unit 11. These LED lamps are lit in a color indicating a loaded state when the test device B is loaded at a position immediately below the loading unit 11.
  • the loading unit 11 is provided with six sensors 12. These sensors 12 are used to detect which of CH1 to CH6 is loaded with the test device B.
  • the reading means 2 includes light emitting modules 21A, 21B, 21C and light receiving sensor modules 22A, 22B.
  • the light emitting modules 21A, 21B and the light receiving sensor module 22A perform a function of reading the reagent holding portions 8A, 8B, 8C through the measurement window 62 of the test tool B and a function of reading the inspection item code 63.
  • the light emitting module 21C and the light receiving sensor module 22B have a function of reading the patient information entry column 64.
  • the reading means 2 in addition to the configuration in which the light emitting modules 21A, 21B, 21C and the light receiving sensor modules 22A, 22B are integrally supported and driven, for example, the light emitting modules 21A, 21B and the light receiving sensor module 22A, The module 21C and the light receiving sensor module 22B may be supported and driven separately. Further, unlike the present embodiment, the configuration may be such that the reagent holding units 8A, 8B, and 8C, the examination item code 63, and the patient information entry column 64 are read by one light receiving sensor module 22A. In this case, the light receiving sensor module 22A having an enlarged light receiving range may be used.
  • the light emitting modules 21A and 21B are modules in which, for example, LEDs are built, and emit light having different wavelengths.
  • the light emitted from the light emitting modules 21 ⁇ / b> A and 21 ⁇ / b> B is linear light extending in the longitudinal direction of the test device B.
  • the light receiving sensor module 22A has a configuration in which, for example, a plurality of photodiodes are arranged or an optical sensor such as an area sensor, and generates an output corresponding to the luminance of the received light.
  • the light receiving range of the light receiving sensor module 22 ⁇ / b> A is a thin band extending in the longitudinal direction of the test tool B.
  • the reading means 2 when the reading means 2 is positioned directly above the test device B, the light receiving sensor module 22A faces the measuring window 62, and the light emitting modules 21A and 21B sandwich the light receiving sensor module 22A and the measuring window 62 The light is irradiated at an angle of about 45 degrees.
  • the reagent holding units 8A, 8B, and 8C can be read as image data of at least two types of hues.
  • the light emitting module 21C is a module in which, for example, an LED is built, and irradiates light of a predetermined wavelength.
  • the light emitted from the light emitting module 21 ⁇ / b> C is linear light extending in the longitudinal direction of the test tool B.
  • the light receiving sensor module 22B has, for example, a configuration in which a plurality of photodiodes are arranged, or a configuration having an optical sensor such as an area sensor, and generates an output corresponding to the luminance of the received light.
  • the light receiving range of the light receiving sensor module 22B is a thin band extending in the longitudinal direction of the test device B.
  • the light receiving sensor module 22B faces the patient information entry column 64, and the light emitting module 21C is 45 degrees with respect to the patient information entry column 64. It is arranged to irradiate light at a certain angle.
  • the reading means 2 is capable of reciprocating directly above the six test devices B loaded in the loading unit 11. Specifically, it is slidably supported by a guide bar (not shown) extending in the direction in which the six test devices B are arranged, and driving means such as a motor, a pulley, and a belt (all not shown). Driven by.
  • driving means such as a motor, a pulley, and a belt (all not shown).
  • the reading unit 2 reciprocates directly above the six test tools B
  • the light emitting modules 21A and 21B and the light receiving sensor module 22A alternately change the reagent holding portions 8A, 8B, and 8C of the six test tools B and the inspection item code 63. Can be read.
  • the light emitting module 21C and the light receiving sensor module 22B can sequentially read the patient information entry fields 64 of the six test devices B.
  • the reading unit 2 can perform a reading process on the loaded test tools B.
  • the arrangement of the examination item code 63 and the patient information entry column 64 with respect to the measurement window 62 is arbitrary.
  • the reagent holding units 8A, 8B, 8C and the patient information entry column 64 are read by the light receiving sensor module 22A, and the light receiving sensor module 22B.
  • the inspection item code 63 may be read.
  • the controller 3 includes, for example, a CPU, a ROM, a RAM, and an interface.
  • the CPU controls the entire optical measuring apparatus A.
  • the ROM stores various programs and parameters for processing performed by the CPU.
  • the RAM temporarily stores programs, measurement results, and the like.
  • the interface performs an input / output function of the controller 3.
  • the controller 3 uses the inspection result, which is the result of analyzing the image data obtained by the light receiving sensor module 22A, and the image data obtained from the light receiving sensor module 22B to output the inspection result output data. Generate. This inspection result output data is sent to the printer 4.
  • the printer 4 is a device that outputs an inspection result for the test tool B based on the inspection result output data sent from the controller 3, and includes, for example, a thermal print head.
  • an inspection result corresponding to the inspection item is printed as shown in FIG.
  • the external connector 5 is a terminal for transmitting inspection result output data to the outside of the optical measuring apparatus A, and serial communication based on, for example, the RS-232C standard is possible.
  • an information processing apparatus such as a personal computer Pc is connected to the external connector 5.
  • the personal computer Pc performs processing such as displaying the inspection result output data transmitted from the external connector 5 on a display, or recording it on an internal storage device or a recording medium.
  • FIG. 8 shows an example of inspection using the optical measuring device A.
  • the horizontal axis represents time
  • the reaction progress curve Cv indicates the progress of the reaction for each test device B loaded in CH1 to CH6.
  • the reference level Lv drawn with a dotted line indicates the progress of the reaction that can be inspected.
  • the alternate long and short dash line in this figure shows the locus of the reading means 2 that reciprocates in CH1 to CH6.
  • influenza tests were performed on six patients. Samples collected from these patients were applied to the test tool B, and the work of loading the test tool B into the loading unit 11 was sequentially performed. In the six test devices B, the names of the patients are entered in the patient information entry column 64.
  • the test device B to which the specimen was first applied was loaded into CH1 of the loading unit 11.
  • a loading signal is sent from the sensor 12 that has detected this loading to the controller 3.
  • the reading means 2 reads the inspection item code 63 in the reading process Pf when passing for the first time directly above the test tool B of CH1.
  • the controller 3 sets a reaction completion time Tr1 corresponding to the inspection item described in the inspection item code 63 for CH1.
  • a plurality of reading processes Pt are performed each time the reading unit 2 crosses CH1 from the CH1 loading time determined by the detection of the sensor 12 until the reaction completion time Tr1 elapses. In the reading process Pt, reading of the reagent holding units 8A, 8B, and 8C is repeated.
  • the result read within the reaction completion time Tr1 is not used for the inspection. And after reaction completion time Tr1 passes, the reading result of reagent holding part 8A, 8B, 8C obtained by the reading process P performed initially is used for an influenza test
  • the inspection processes for CH2 to CH6 are performed.
  • the inspection items of the test device B loaded in CH1 to CH6 are the same, and the reaction completion times Tr1 to Tr6 are the same. For this reason, reading processing used for inspection is performed in the order of loading for CH1 to CH6.
  • the controller 3 generates test result output data for each of CH1 to CH6 using the test items and test results of each test tool B and the image data read from the patient information entry column 64. These inspection result output data are sequentially printed by the printer 4 as shown in FIG.
  • the contents to be printed include date and time, identification number, loading position (any one of CH1 to CH6), examination item, examination result, and name written in the patient information entry column 64.
  • This printed name is the image data printed in the patient information entry field 64 read by the light receiving sensor module 22B of the reading means 2 as it is.
  • image processing such as binarization processing is appropriately performed on the image data in the patient information entry field 64 for the purpose of clear printing.
  • FIG. 10 shows another example of the inspection using the optical measuring apparatus A.
  • the program executed by the controller 3 is different from that in the above-described embodiment.
  • This program is configured to perform a preliminary inspection using the result of the reading process Pt from when the test tool B is loaded until the reaction completion time Tr1 to Tr6 elapses.
  • a preliminary inspection is performed on the result of the reading process Pt after the reading process Pf is performed.
  • the reaction progress curve Cv of CH2 progresses more steeply than a general reaction progress curve Cv (a two-dot chain line curve in the figure). This is because the specimen applied to the test device B loaded in CH2 tends to react with the reagent at a reaction rate faster than usual. For this reason, it is recognized by the preliminary inspection using the result of the second reading process Pt that the reaction exceeds the reference level Lv. Then, the controller 3 determines that the reaction in the test device B has been completed earlier than the assumed reaction completion time Tr2, and outputs that effect by the printer 4. In other words, the second reading process Pt is replaced with the reading process P described above. Then, the controller 3 ends the inspection process for the test tool B.
  • FIG. 11 shows a print example of the inspection result according to this embodiment.
  • six test pieces are loaded in the order of CH1 to CH6.
  • the inspection process of the test tool B loaded in CH2 is completed by the preliminary inspection described above, the result of CH2 is printed before the result of CH1.
  • the name of the patient is recorded for each examination result printed from the printer 4. For this reason, it is possible to easily collate with which patient the result of the test continuously performed on several patients.
  • the optical measuring device A can be loaded with a plurality of test devices B.
  • the inspection is automatically performed after the reaction completion times Tr1 to Tr6 corresponding to the test items have elapsed. For this reason, the user of the optical measuring apparatus A does not need to perform time management from when the specimen is applied to each test tool B until the examination can be performed.
  • This is suitable for a test performed in a short time on a large number of patients, for example, an influenza test. Since the name of the patient is written in each test result, it is possible to prevent the test result of one patient from being collated as that of another patient.
  • the inspection process is performed before the entire reaction completion time Tr2 has elapsed. Can be completed. Thereby, the inspection time of the test tool B can be shortened reasonably. Further, when the inspection is completed in a shorter time than usual by the preliminary inspection, the order in which the inspection results of the plurality of test devices B are printed is different from the order assumed from the order in which these test devices B are loaded. Sometimes. However, according to this embodiment, for example, the name entered in the patient information entry column 64 is printed as it is together with each test result.
  • the test result and the patient can be appropriately verified. Furthermore, even when the influenza test and the allergy test are mixed, even when the reaction completion times Tr1 to Tr6 of CH1 to CH6 are different from each other, the order of loading in CH1 to CH6 and the order in which the tests are completed, that is, the test results are The order of printing can be very different. Even in such a case, since the name and the like entered in the patient information entry column 64 are printed as they are along with the examination result, it is possible to easily collate the examination result with the patient.
  • the patient information entry column 64 of the test device B bulges in a plateau shape. For this reason, when a user or a patient enters his / her name, it can be prevented that the user or patient enters information in an area other than the patient information entry field 64 by mistake. Further, by making the surface of the patient information entry column 64 a relatively rough textured surface, it is possible to facilitate entry with a felt pen, for example.
  • test piece and the optical measurement device according to the present invention are not limited to the above-described embodiments.
  • the specific configuration of each part of the test piece and the optical measuring device according to the present invention can be varied in design in various ways.
  • the number of reagent holding units is not limited to three types of 8A, 8B, and 8C, and can be further increased.
  • the shape of the patient information entry column 64 is not limited to a rectangular shape, but may be any shape as long as patient specific information such as a name can be easily entered. Instead of making the surface of the patient information entry field 64 a textured surface, for example, a white paint suitable for absorbing ink may be applied.
  • the swelling of the patient information entry column 64 is suitable for entering so as not to protrude from the patient information entry column 64, but the test piece according to the present invention is not limited to this, for example, on a flat surface. An area bordered by the boundary line may be used as the patient information entry field 64.
  • the reading unit 2 is not limited to the configuration in which the light emitting modules 21A and 21B and the light receiving sensor module 22A, the light emitting module 21C and the light receiving sensor module 22B are scanned integrally.
  • the light emitting module 21C and the light receiving sensor module 22B for reading the patient information entry column 64 may be scanned independently of the light emitting modules 21A and 21B and the light receiving sensor module 22A.
  • the reading means 2 is not limited to the configuration including the read-only light emitting module 21C and the light receiving sensor module 22B in the patient information entry column 64, and at least one or all of the light emitting modules 21A and 21B and the light receiving sensor module 22A are included. The configuration may also be used for reading the patient information entry column 64.
  • Either the printer 4 or the external connector 5 as output means may alternatively be provided. Further, a liquid crystal display for displaying inspection result output data on the optical measuring device A may be provided.
  • the test device and the optical measurement device according to the present invention are not limited to influenza tests, and can be used for various tests using immunochromatography, and for various optical measurement methods.

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PCT/JP2008/071138 2008-11-20 2008-11-20 試験具および光学的測定装置 WO2010058471A1 (ja)

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EP08878268A EP2367002A4 (en) 2008-11-20 2008-11-20 TEST TOOL AND OPTICAL MEASURING DEVICE
CN2008800080174A CN101790686B (zh) 2008-11-20 2008-11-20 试验器具和光学测定装置
US12/517,776 US8182761B2 (en) 2008-11-20 2008-11-20 Test instrument and optical measurement apparatus
PCT/JP2008/071138 WO2010058471A1 (ja) 2008-11-20 2008-11-20 試験具および光学的測定装置
US13/455,253 US8574511B2 (en) 2008-11-20 2012-04-25 Test instrument and optical measurement apparatus

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CN101790686B (zh) 2013-10-16
US20110058994A1 (en) 2011-03-10
US8182761B2 (en) 2012-05-22
US20120207653A1 (en) 2012-08-16
EP2367002A4 (en) 2012-07-11

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