WO2021014216A1 - Lecteur d'immunochromatographie, système d'immunochromatographie et méthode de détection d'hémoglobine - Google Patents

Lecteur d'immunochromatographie, système d'immunochromatographie et méthode de détection d'hémoglobine Download PDF

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Publication number
WO2021014216A1
WO2021014216A1 PCT/IB2020/000612 IB2020000612W WO2021014216A1 WO 2021014216 A1 WO2021014216 A1 WO 2021014216A1 IB 2020000612 W IB2020000612 W IB 2020000612W WO 2021014216 A1 WO2021014216 A1 WO 2021014216A1
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WO
WIPO (PCT)
Prior art keywords
reader
membrane
specimen
data
cartridge
Prior art date
Application number
PCT/IB2020/000612
Other languages
English (en)
Inventor
India ELSDON
Timothy Mcdonald
David cCCOURT
Yasunobu Masuda
Original Assignee
Hitachi Chemical Diagnostics Systems Co., Ltd.
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.)
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Publication date
Application filed by Hitachi Chemical Diagnostics Systems Co., Ltd. filed Critical Hitachi Chemical Diagnostics Systems Co., Ltd.
Publication of WO2021014216A1 publication Critical patent/WO2021014216A1/fr

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Classifications

    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • 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
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • G01N33/721—Haemoglobin
    • 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
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/021—Identification, e.g. bar codes
    • B01L2300/022—Transponder chips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099—Characterised by type of test elements
    • G01N2035/00108—Test strips, e.g. paper
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00009—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones
    • 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
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the present disclosure relates to an immunochromatography reader, an immunochromatography system, and a hemoglobin detection method and more particularly relates to the detection of hemoglobin that may be present in a solution of feces of a specimen.
  • a fecal occult blood test for detecting the blood from the feces has been conducted.
  • a fecal occult blood test for detecting the blood from the feces has been conducted.
  • a feces solution of a specimen has been tested by detecting hemoglobin in the blood by adopting a chemical method and/or an immunological antibody-antigen reaction.
  • a laboratory for analyzing a large number of specimens and pieces of special analytical equipment owned by a large-scaled hospital have been used.
  • Patent Literature 1 discloses an apparatus for testing a large number of patients by using the immuno-chromatography in which an antigen-antibody reaction and the chromatography are combined.
  • the present disclosure is made in consideration of the above described situations, and an object of the present disclosure is to provide an immunochromatography reader, an immunochromatography system, and a hemoglobin detection method that facilitate a fecal occult blood test by using a quick test kit with the immuno-chromatography and improve the precision of the fecal occult blood test.
  • an immunochromatography reader includes: a cartridge arrangement unit to set a cartridge including an immunochromatography membrane to detect hemoglobin which may be present in a solution of feces as a specimen, the cartridge arrangement unit including a reference position and a detection position; a first reading unit disposed at the reference position over the cartridge arrangement unit to read a reference status of the membrane; a second reading unit disposed at the detection position over the cartridge arrangement unit to read a detection status of the membrane; a timer measuring a time passing from an instant when the first reading unit has read that the reference status of the membrane is changed; and a processing unit transforming in a predetermined manner the detection status read by the second reading unit at a predetermined time based on the timer to output the transformed data.
  • the reference position and the detection position may be arranged on an upstream side and a downstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the reference position and the detection position may be arranged on a downstream side and an upstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the first reading unit may read a penetration state of a specimen at the reference position of the membrane as the reference status.
  • the second reading unit may read a coloration state at the detection position of the membrane as the detection status.
  • the reference position and the detection position may be the same position, and a single reading unit may serve both as the first reading unit and the second reading unit.
  • An immunochromatography reader includes: a cartridge arrangement unit to set a cartridge including an immunochromatography membrane to detect hemoglobin which may be present in a solution of feces as a specimen, the cartridge arrangement unit including a reading position; a reading unit disposed at the reading position over the cartridge arrangement unit to read a reference status of the membrane and a detection status of the membrane; a timer measuring a time passing from an instant when the reading unit reads that the reference status of the membrane is changed; and a processing unit transforming in a predetermined manner the detection status read by the reading unit at a predetermined time based on the timer to output the data obtained by the transformation.
  • the reading unit may read a penetration state of a specimen at the reading position of the membrane as the reference status, and may read a coloration state at the reading position of the membrane as the detection status.
  • the data output from the processing unit may include the presence or absence of hemoglobin in the specimen or content thereof.
  • the immunochromatography reader may further include a memory unit storing the data output from the processing unit.
  • the immunochromatography reader may further include a display area showing the data output from the processing unit.
  • the immunochromatography reader may further include an interface intermediating with a network to transmit, to the network, the data output from the processing unit.
  • the interface may transmit, to the network, the data output from the processing unit to store the data in a server in a cloud.
  • the immunochromatography reader may further include an interface intermediating with the network, data output by a processing unit may be transmitted and received via the network, and the interface may transmit, to the network, the data output from the processing unit.
  • An immunochromatography system includes: the immunochromatography reader; and a terminal device including: an interface intermediating with the network; and a display, the terminal device communicating with the reader via the network and showing, on the display, the data output from the processing unit of the reader.
  • the interface of the terminal device may transmit, to the network, the data output from the processing unit of the reader to store the data in a server in a cloud.
  • the immunochromatography system includes the immunochromatography reader; and a terminal device to communicate with the reader via the network, and the terminal device includes: an interface intermediating with the network; a processing unit transforming the data received from the network via the interface to a data including the presence or absence of hemoglobin in the specimen or a content thereof and outputting the data; and a display showing the data output from the processing unit.
  • the terminal device may further include a memory unit storing the data output from the processing unit of the terminal device.
  • the interface of the terminal device may transmit the data output from the processing unit of the terminal device to the network to store the data in a server in a cloud.
  • the interface of the terminal device may receive, from the network, information transmitted from a server in a cloud for identifying the specimen.
  • a method of detecting hemoglobin includes the steps of: setting a cartridge in a reader, the cartridge including an immunochromatography membrane to detect hemoglobin which may be present in a solution of feces as a specimen, the reader including a reference position and a detection position; adding the specimen to the specimen adding position of the cartridge disposed in the reader to cause the specimen to be penetrated in the membrane; reading a reference status of the membrane at the reference position; reading a detection status of the membrane at the detection position; measuring a time passing from an instant when a change of the reference status is read; and transforming the detection status in which the passed time is a predetermined time to data for hemoglobin in the specimen and outputting the data.
  • the reference position and the detection position may be arranged on an upstream side and a downstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the reference position and the detection position may be arranged on a downstream side and an upstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the reference position and the detection position may be the same position.
  • a method of detecting hemoglobin includes the steps of: setting a cartridge in a reader, the cartridge including an immunochromatography membrane to detect hemoglobin which may be present in a solution of feces as a specimen, the reader including a reading position; adding the specimen to a specimen adding position of the cartridge disposed in the reader to cause the specimen to be penetrated in the membrane; reading a reference status of the membrane at the reading position; reading a detection status of the membrane at the reading position; measuring a time passing from an instant when a change of the reference status is read; and transforming the detection status in which the passed time is a predetermined time to data for hemoglobin in the specimen and outputting the data.
  • the step of reading the reference status may comprise a step of reading a penetration state of the specimen into the membrane.
  • the step of reading the detecting status may comprise a step of reading a coloration of the membrane.
  • the data for hemoglobin in the specimen may include the presence or absence of hemoglobin in the specimen or content thereof.
  • the present disclosure may facilitate a fecal occult blood test by using a quick test kit with the immuno-chromatography and improve the precision of the fecal occult blood test.
  • FIG. 1 is a diagram illustrating a schematic configuration of an immunochromatography system.
  • FIG. 2 is a diagram illustrating a cartridge.
  • FIG. 3 is a three-view drawing illustrating an appearance of a reader.
  • FIG. 4 is a schematic cross sectional view of a reader.
  • FIG. 5 is a block diagram schematically illustrating functions of a reader.
  • FIG. 6 is a block diagram schematically illustrating functions of a tablet.
  • FIG. 7 is a flowchart illustrating a series of steps of a hemoglobin detection method.
  • the present embodiment is supposed to be used for a screening test (a fecal occult blood test) applied to the bleeding from a lower digestive tract by dripping a solution of feces as a specimen (hereinafter referred to as a feces solution) to on a membrane incorporated in a cartridge and analyzing whether hemoglobin is present in the feces solution based on the immuno-chromatography.
  • a screening test a fecal occult blood test
  • a solution of feces as a specimen hereinafter referred to as a feces solution
  • ischemic enteritis As a disease involving the bleeding from the lower digestive tract, in addition to bowel cancers, ischemic enteritis, drug-induced bowel inflammations, infectious enteritis, colitis ulcerosa, Crohn’s diseases and the like are taken as examples.
  • the fecal occult blood test can be used for a diagnosis and a prediction of these diseases and the like.
  • the diagnosis of the diseases using the fecal occult blood test can be combined with a medical treatment of the diseases.
  • surgical operations, administrations of a medicine, diet restrictions and the like are taken as examples.
  • FIG. 1 is a diagram schematically illustrating a configuration of an immunochromatography system according to the present embodiment.
  • the system includes, in a testing spot 101 where a fecal occult blood test is conducted such as a medical examination room or a test room in a clinic 102, a reader 10 of an immunochromatography reader used for reading the cartridge 30 used for conducting a fecal occult blood test by users such as doctors or nurses, and a tablet 50 that is a terminal device that can communicate with the reader 10 and display the fecal occult blood test result.
  • a testing spot 101 where a fecal occult blood test is conducted such as a medical examination room or a test room in a clinic 102
  • a reader 10 of an immunochromatography reader used for reading the cartridge 30 used for conducting a fecal occult blood test by users such as doctors or nurses
  • a tablet 50 that is a terminal device that can communicate with the reader 10 and display the fecal occult
  • the reader 10 is set with a different cartridge 30 for each specimen, and in a case where the feces solution of the specimen is dripped on the cartridge 30, the reader 10 automatically reads a coloration by the immuno-chromatography, and transforms the read data to data of an analysis result of a fecal occult blood test including a positive result or a negative result of a fecal occult blood test, hemoglobin content and the like.
  • the reader 10 may read identification data of the cartridge 30.
  • the reader 10 stores the read data of the cartridge 30 and the data of the analysis result of the fecal occult blood test and transmits the data to a network.
  • the feces solution of the specimen may be a solution in which feces are dissolved or the mixture of the solution in which feces are dissolved and a diluted solution.
  • a solution is for stably preserving a feces specimen and may include a buffer solution, a stabilizer and the like.
  • the cartridge 30 is used for analyzing the hemoglobin in the feces solution of the specimen for conducting the fecal occult blood test and incorporates the membrane that shows a color in a case where, by the immuno-chromatography, the hemoglobin is detected.
  • the cartridge 30 is set to the reader 10 and the feces solution of the specimen is dripped on the cartridge 30.
  • the tablet 50 communicates with the reader 10, receives the data read by the reader 10 and data of an analysis result of a fecal occult blood test, displays the data for a user who conducts the fecal occult blood test in the testing spot 101 by using the reader 10, and provides data after applying the predetermined processing thereto.
  • the data read by the reader 10 received from the reader 10 may be transformed to the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like.
  • the reader 10 and the tablet 50 can communicate via, for example, a wireless LAN such as Bluetooth and Wi-Fi.
  • the system may include a personal computer 60 that is present in a spot different from the testing spot 101 where the fecal occult blood test is conducted in the clinic 102.
  • the personal computer 60 communicates with the reader 10 and the tablet 50 that are present in the testing spot 101 and receives, from the reader 10 and the tablet 50, the data of the analysis result of the fecal occult blood test to display it, or provides data after applying the predetermined processing to it.
  • the analysis result of the fecal occult blood test may be taken in a patient’s electronic health record and the result may be referred to in a case where a doctor makes a diagnosis of a patient.
  • a premises LAN can be established by a wireless LAN such as Wi-Fi and a wired LAN such as Ethernet.
  • the reader 10 and the tablet 50 that are present in the testing spot 101 can communicate with the personal computer 60 present in the spot different from the testing spot 101 in the clinic 102 via the network of such premises LAN.
  • the premises network of the clinic 102 can be connected with a cloud 110 via the Internet.
  • the tablet 50 and the personal computer 60 in the clinic 102 may store, in a server 111 in the cloud 110, the data of the analysis result of the fecal occult blood test and the data of the electronic health record or the like taking in the analysis result of the fecal occult blood test through the premises network and the Internet. Further, the tablet 50 and the personal computer 60 in the clinic 102 may read the data of the analysis result of the fecal occult blood test and the data of the electronic health record or the like taking in the analysis result of the fecal occult blood test stored in the server 111 in the cloud 110 when necessary.
  • the server 111 in the cloud 110 may store the identification data of the cartridge 30 when the reader 10 reads the cartridge 30, the data of a read coloration and the like, and the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like that is subjected to the transformation.
  • the server 111 in the cloud 110 is connected with a database of patient history data 120 and a database of market information 130.
  • the tablet 50 and the personal computer 60 in the clinic 102 may access these databases via the server 111 in the cloud 110 and may use the patient history data 120 and the market information 130 by cooperating them to the data of the analysis result of the fecal occult blood test and the data of the electronic health record or the like taking in the analysis result of the fecal occult blood test.
  • the past patient history data 120 may be taken into data of an electronic health record of a patient who is decided to be positive in the fecal occult blood test and the data of the analysis result of the fecal occult blood test may be added to the patient history data 120.
  • a written report of the analysis result of the fecal occult blood test may be prepared by referring to updated information obtained from the market information 130.
  • the immunochromatography system according to the present embodiment can be used for other facilities such as a hospital, a laboratory for analysis, and a research institution without being limited to a clinic, and can be used to a spot outside a facility such as an outdoor spot.
  • the personal computer 60 does not need to be present in the same facility as the testing spot 101 in the clinic 102, and the personal computer 60 can be used through the Internet even if a user is present in another facility or a different spot such as a private home and a visiting destination.
  • FIG. 2 is a diagram illustrating a cartridge used for conducting a fecal occult blood test.
  • FIG. 2 (a) is a perspective view of a cartridge and
  • FIG. 2 (b) is a schematic diagram schematically illustrating a configuration of a membrane of the immuno chromatography incorporated in a cartridge.
  • the cartridge 30 has predetermined width and thickness so that the elongated membrane 40 of the immuno-chromatography can be clamped and housed and has a slightly flat and roughly rectangular parallelepiped shape that extends in a long side direction of the membrane 40 and surrounds and supports the membrane 40.
  • the cartridge 30 has at one end thereof, a head 32 that extends from one end of the membrane 40 in the long side direction and houses a predetermined portion of the membrane 40.
  • the head 32 has, at both sides, blades 34 and is formed to be thick to facilitate gripping of the cartridge 30, and in the center of an upper surface of head 32, formed is a specimen dripping unit 33 formed with an opening so that the feces solution of the specimen can be dripped on the membrane 40.
  • a main body 31 extends from the head 32 of the cartridge 30 along the long side direction of the membrane 40.
  • a window 37 formed with an opening so that the coloration by the immuno-chromatography of the membrane 40 can be observed.
  • a test line 44 is provided at a prescribed position on the membrane 40 that can be viewed through the window 37 of the main body 31.
  • a control line 45 may be provided at a prescribed position on the membrane 40 that can be viewed through the window 37 of the main body 31.
  • a tip of the main body 31 may be formed with an RFID embedding unit 38 in which an RFID chip that stores the identification data of the cartridge 30 is embedded. Identification data of the cartridge 30 is unique for each cartridge 30.
  • projections 39 are provided that engage with the reader 10 and support the cartridge 30 in a case where the cartridge 30 is set to the reader 10.
  • the projections 39 interlocking with the blade 34 come to be unengaged with the reader 10.
  • the cartridge 30 may be made of a black resin so that an observation is facilitated by differentiating from colors of a labeled substance such as those exhibited by the test line 44 and the control line 45, which are described later.
  • a base substrate 41 extending from one end of the membrane 40 to the other end is made of porous materials so that the feces solution of the specimen can be penetrated thereto from one end on the upstream side to the other end on the downstream side by a capillary action.
  • One end of the membrane 40 is formed with a sample pad 42 that is positioned immediately below the specimen dripping unit 33 of the cartridge 30, temporarily absorbs the dripped feces solution of the specimen, and gradually supplies it toward the downstream side.
  • FIG. 2 (b) illustrates a droplet of specimen 200 dripped to the membrane 40 through the specimen dripping unit 33 and hemoglobin (Hb) 201 that may be included in the specimen 200.
  • a conjugate pad 43 that is in contact with the sample pad 42 and is applied with mouse anti-human HblgG of a labeled antibody 202 labeled with red latex of a labeled substance.
  • the test line 44 applied with the mouse anti-human HblgG of the first capture antibody 203.
  • the control line 45 applied with goat anti-mouse IgG of a second capture antibody 204 may be formed.
  • the other end of the membrane 40 is provided with an absorption pad 46 for absorbing the specimen arriving from the upstream side of the membrane 40 through the penetration.
  • the labeled substance is not limited to red latex, and may be gold colloids, colored particles such as colored latexes, fluorescent particles, chromogenic substances, and fluorescent substances.
  • An antibody used for the conjugate pad 43 may be an antibody to hemoglobin, or a fragment of the antibody, or aptamer.
  • a capture antibody used for the test line 44 may be the antibody to the hemoglobin, or the fragment of the antibody, or the aptamer, and it may be the same or different to/from that used for the conjugate pad 43.
  • An antibody to an antibody used for the conjugate pad 43, or a fragment of the antibody, or aptamer is also possible.
  • An antibody used for the conjugate pad 43 and an antibody used for the test line 44 are not limited to a mouse-derived antibody, and may be a rat-derived antibody, a hamster-derived antibody, a rabbit-derived antibody, a camel-derived antibody, an alpaca- derived antibody, and a goat-derived antibody.
  • the antibody may be a polyclonal antibody or may be a monoclonal antibody, and as the monoclonal antibody, the monoclonal antibody produced by the hybridoma, a genetic modification monoclonal antibody and the like are taken as examples.
  • antibody fragments antibody fragments from which Fc parts are removed such as the Fab obtained by a papain treatment, the F(ab’)2 obtained by a pepsin treatment, the Fab’ obtained by the pepsin treatment-reduction treatment are taken as an example.
  • the labeled antibody applied to the conjugate pad 43 traps the hemoglobin in the antigenic agent and forms an antigen- antibody complex.
  • the antigen-antibody complex is supplemented by the first capture antibody 203 applied to the test line 44 and the test line 44 shows a color.
  • the labeled antibody that does not form the antigen- antibody complex is not supplemented by the first capture antibody 203 applied to the test line 44, and instead is supplemented by the second capture antibody 204 applied to the control line 45 present on the downstream side, and the control line 45 shows a color.
  • the coloration of the test line 44 is optically read by the reader 10.
  • An analysis by the immuno-chromatography uses a penetration in which the feces solution of the specimen advances on the membrane toward the downstream side by the capillary action, and thus, to detect the coloration of the test line 44, a time management is necessary. For example, in a case where a measurement timing is too early, the coloration becomes insufficient and alternatively, in a case where the measurement timing is too late, there is a risk of fading. Further, in a case where the hemoglobin concentration or the like in the specimen is analyzed in a quantitative way, the analysis by a visual observation is difficult because it is necessary to read intensity of the coloration.
  • the present embodiment allows enhancing the precision of the analysis by managing a measurement time by the reader 10 and the analysis of the specimen in a quantitative way by reading the intensity of the coloration of the membrane 40 by an optical sensor of the reader 10.
  • FIG. 3 is a three-view drawing illustrating an appearance of the reader 10.
  • FIG. 3(a) is a top view of the reader 10
  • FIG. 3(b) is a front view of the reader 10
  • FIG. 3(c) is a left side-view of the reader.
  • the reader 10 has a left side surface formed with an opening 11 to receive the main body 31 of the cartridge 30, and from the opening 11, a cartridge housing unit 12 that is a cartridge arrangement unit that forms hollow space to house the main body 31 of the cartridge 30 extends.
  • the reader 10 has a roughly rectangular parallelepiped shape that extends along the long side direction of the cartridge housing unit 12 so as to surround the cartridge housing unit 12.
  • the reader 10 has a first display area 13 and a second display area 14 across a front surface to both an upper surface and a lower surface.
  • the first display area 13 has two display subareas that are drawn with a symbol“+” and a symbol respectively, and the analysis result of the fecal occult blood test is represented by, in a case where the analysis result of the fecal occult blood test is positive, turning on the light of the + display subarea and alternatively, in a case where the analysis result is negative, tuning the light of the - display subarea.
  • the second display area 14 has two display subareas that are drawn with a droplet symbol and a clock symbol respectively.
  • Turning on the light of the droplet symbol subarea indicates, for example, that the feces solution of the specimen is in a status of readiness to be dripped in a case where the cartridge 30 is set to the reader 10, and the light is turned off after the detection of the dripping of the specimen.
  • the clock symbol subarea is lighted on, for example, during a time period in which a time is measured by a timer described later.
  • FIG. 4 is a cross sectional view illustrating a schematic structure of the reader 10.
  • FIG. 4 schematically illustrates a cross section of the reader 10 corresponding to a section line III-III in the top view of FIG. 3(a).
  • the cartridge housing unit 12 extends from the opening 11 of the left side surface to inside.
  • the cartridge housing unit 12 houses the main body 31 of the cartridge 30 inserted through the opening 11 and fixes the cartridge 30 by removably engaging with the projection 39 of the cartridge 30 at an unillustrated engagement.
  • a first reading unit 15 is provided to a reference position that is distant from the opening 11 by a predetermined distance.
  • the first reading unit 15 is provided immediately above the main body 31 of the cartridge 30 so that the membrane 40 can be read through the window 37 of the cartridge 30.
  • the reference position corresponds to a predetermined position that is on the downstream side from the sample pad 42 of the membrane 40 in the cartridge 30 housed in the cartridge housing unit 12.
  • the reference status may indicate either one of a status where the feces solution of the specimen is not penetrated in the membrane 40 at the reference position and a status where the feces solution of the specimen is penetrated in the membrane 40 at the reference position. Further, the reference status may be quantitative data such as the reflectance of the membrane 40 at the reference position.
  • a second reading unit 16 is provided to a detection position at the position distant from the opening 11 by the predetermined distance.
  • the second reading unit 16 is provided immediately above the main body 31 of the cartridge 30 so that the membrane 40 can be read through the window 37 of the cartridge 30.
  • the detection position corresponds to a position of the test line 44 provided to the membrane 40 in the cartridge 30 housed in the cartridge housing unit 12.
  • the second reading unit 16 can optically read the intensity of the coloration of the test line 44 at the detection position as a detection status.
  • the reference position and the detection position are arranged on an upstream side and a downstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the reference position and the detection position may be arranged on a downstream side and an upstream side in a penetration direction of the specimen on the membrane of the set cartridge, respectively.
  • the followings are taken as examples: 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1,
  • the reference position and the detection position may be the same position, and a single reading unit may serve both as the first reading unit and the second reading unit.
  • the first reading unit 15 and the second reading unit 16 include a photo-detection element such as a photodiode and light sources such as an LED and a laser diode so as to be able to read the reference status and the detection status respectively.
  • the first reading unit 15 and the second reading unit 16 may further include optical elements such as a collecting lens and a filter.
  • the first reading unit 15 and the second reading unit 16 may read the reference status and the detection status respectively by using visible light or by using infrared light and/or ultraviolet light.
  • the second reading unit 16 may read the fluorescent substance by irradiating the fluorescent substance with the ultraviolet light.
  • an RFID reader 18 may be provided at the deep side of the first reading unit 15 and the second reading unit 16.
  • the RFID reader 18 is provided to face the RFID embedding unit 38 so as to be able to communicate with the RFID chip embedded in the RFID embedding unit 38 formed to the edge of the main body 31 of the cartridge 30.
  • the RFID reader 18 causes an electromagnetic field to be generated and causes the RFID chip embedded in the RFID embedding unit 38 of the cartridge 30 to be excited to receive a response of the identification data of the cartridge 30 from the RFID chip.
  • a deepest portion of the cartridge housing unit 12 may be provided with a cartridge detection sensor 17 that detects the insertion of the main body 31 of the cartridge 30 up to the deepest portion of the cartridge housing unit 12.
  • the cartridge detection sensor 17 may be a sensor such as a micro-switch that mechanically detects an arrival of the cartridge 30 to the deepest portion of the cartridge housing unit 12 or may be a sensor that optically detects the arrival of the cartridge 30.
  • the reader 10 includes a circuit board 19 constituted from an electronic circuit that controls each unit of the reader 10 and processes the data handled by the reader 10 and a battery 20 that supplies a power source for driving the reader 10.
  • the circuit board 19 includes a processor, a memory and the like for realizing functions of the reader 10 described later.
  • the battery 20 can drive the reader 10 over a predetermined period of time and may be a primary battery such as, for example, a lithium battery.
  • FIG. 5 is a block diagram schematically illustrating the functions of the reader 10.
  • the reader 10 includes a processing unit 21 that includes a processor and memories such as a ROM and a RAM, controls operations of the reader 10 and applies predetermined processing to the data handled by the reader 10.
  • the processing unit 21 is formed to the circuit board 19 illustrated in FIG. 4 and an IP (Internet Protocol) address may be stored in a memory as the identification data of the reader 10.
  • IP Internet Protocol
  • the reader 10 includes the first reading unit 15, the second reading unit 16, and the cartridge detection sensor 17 and may further include the RFID reader 18.
  • the first reading unit 15 and the second reading unit 16 read, from the cartridge 30, data of the reference status and data of the detection status respectively and transmit the data to the processing unit 21.
  • the cartridge detection sensor 17 After the arrival of the main body 31 of the cartridge 30 to the deepest portion of the cartridge housing unit 12, the cartridge detection sensor 17 turns on the power source and notifies the processing unit 21 of the detection result.
  • the RFID reader 18 reads the identification data from the cartridge 30 and transmits the identification data to the processing unit 21.
  • the reader 10 may include a timer 23 that measures a time, a memory unit 24 that stores and reads data, a display unit 25 that displays data, and an interface 26.
  • the timer 23, based on the control of the processing unit 21, measures a specified length of time.
  • the memory unit 24 stores the data such as, for example, the data of the reference status and the detection status from the first reading unit 15 and the second reading unit 16 and the identification data of the cartridge 30 from the RFID reader 18.
  • the display unit 25 corresponds to the first display subarea 13 and the second display subarea 14 provided to a front surface of the reader 10.
  • the interface 26 transmits data from the processing unit 21 to the network and receives data from the network to transmit the data to the processing unit 21.
  • the timer 23, the memory unit 24, and the interface 26 may be formed to the circuit board 19 illustrated in FIG. 4 together with the processing unit 21.
  • the timer 23 and the memory unit 24 may be realized as functions of the processing unit 21
  • the reader 10 may be sold as a disposable reader as a set combined with the predetermined number of cartridges 30. In this case, it is sufficient if the reader 10 has the durability that enables reading of the predetermined number of cartridges 30. For example, it is sufficient if the battery 20 of the reader 10 has the capacity necessary for reading the predetermined number of cartridges 30.
  • the reader 10 By setting the reader 10 as a disposable reader, the reliability of the reader 10 can be improved and the burden caused for maintaining the reader 10 can be reduced.
  • FIG. 6 is a block diagram schematically illustrating functions of the tablet 50.
  • the tablet 50 that is a terminal device of the reader 10 includes a processing unit 51 that includes a processor and memories such as a ROM and a RAM, controls operations of the tablet 50, and applies predetermined processing to data handled by the tablet 50.
  • the tablet 50 may include a display 53 such as an LCD, an input unit 54 realized by a touch panel or the like formed to the display 53, a memory unit 52 formed from a flash memory and the like, and an interface 55 communicating with the network.
  • the tablet 50 may store in advance, in the memory unit 52, a table in which a test subject to whom the fecal occult blood test is conducted is associated with identification data of a container of the specimen.
  • FIG. 7 is a flowchart illustrating a series of steps of the hemoglobin detection method.
  • the hemoglobin detection method is used for the fecal occult blood test in which, in the testing spot 101 of the clinic 102 in the immunochromatography system illustrated in FIG. 1, users such as doctors or nurses read the cartridge 30 by using the reader 10.
  • the series of steps are performed by the users operating the tablet 50 together with the reader 10 in the testing spot 101.
  • the reader 10 and the tablet 50 are connected via a wireless LAN such as Wi-Fi and Bluetooth.
  • the tablet 50 is constantly notified of a status of the reader 10 and a read status of the cartridge 30 and an updated status of the reader 10 is set to be reflected to the display 53 of the tablet 50.
  • the users set the cartridge 30 to the reader 10.
  • the reader 10 may be configured such that the power source thereof is turned off and the reader 10 is in a standby mode in which the electric power consumption is suppressed.
  • the tablet 50 recognizes that the cartridge 30 is not set to the reader 10 from a fact that no communication is received from the reader 10 and may display, on the display 53, an image indicating that the cartridge 30 is not set to the reader 10 and a message to urge setting of the cartridge 30.
  • the reader 10 is started up by the cartridge detection sensor 17 detecting a fact that the cartridge 30 has been set, and the processing unit 21 starts a series of procedures.
  • the cartridge detection sensor 17 may be a sensor such as a micro-switch that mechanically detects the setting of the cartridge 30, and may turn on a switch and turn on the power source by the setting of the cartridge 30.
  • the cartridge detection sensor 17 may be a sensor that optically detects the setting of the cartridge 30, notify the processing unit 21 of the setting of the cartridge 30, and may start up the reader from the standby mode.
  • the processing unit 21 may control the RFID reader 18 and read the identification data of the cartridge 30 from the RFID chip embedded in the RFID embedding unit 38 of the cartridge 30.
  • the processing unit 21 stores the read identification data of the cartridge 30 in the memory unit 24, transmits the data to the network via the interface 26, and notifies the tablet 50 of the data.
  • the processing unit 51 of the tablet 50 After receiving the identification data of the cartridge 30 from reader 10 via the interface 55, stores the identification data of the cartridge 30 in the memory unit 52 and displays, on the display 53, an image and a message showing that the cartridge 30 has been set to the reader 10.
  • the tablet 50 illustrated in FIG. 1 displays the image showing that the cartridge 30 has been set to the reader 10.
  • the processing unit 21 of the reader 10 controls the display unit 25 so as to, for example, turn on the light of the display subarea of the droplet symbol of the second display subarea 14 that notifies a fact that the feces solution of the specimen is in a status of readiness to be dripped.
  • step S2 the users drip the specimen on the cartridge 30.
  • the users mount the reader 10 on a horizontal plan such as a desk so that the feces solution of the specimen can be dripped on the specimen dripping unit 33 of the cartridge 30 set to the reader 10. Then, the users drip the feces solution of the specimen on the specimen dripping unit 33 of the cartridge 30 of the mounted reader 10 from the container of the specimen.
  • the users use a predetermined adapter and may drip the feces solution of the specimen by perforating the container of the specimen.
  • the identification data of the container of the specimen may be read and the identification data may be associated with the identification data of the cartridge 30.
  • Such reading of the identification data of the container of the specimen may be performed by using an RFID reader and a barcode reader attached to the tablet 50 or may be performed by a sensor incorporated in the tablet 50.
  • the tablet 50 can associate the identification data of the cartridge 30 to the identification data of the container of the specimen, because in step SI, the tablet 50 has already received, from the reader 10, the identification data of the cartridge 30 and has stored the data in the memory unit 52.
  • a table in which the identification data of the test subject to whom the fecal occult blood test is conducted is associated with the identification data of the container of the specimen, by using data in which the identification data of the cartridge 30 is associated with the identification data of the container of the specimen, the identification data of the test subject can be associated with the identification data of the cartridge.
  • a table in which such identification data of the test subject is associated with the identification data of the container of the specimen may be stored in the server 111 in the cloud 110 and may be referred to by the tablet 50 when necessary.
  • the tablet 50 may update a table with the identification data of the cartridge and the identification data of the test subject that are associated.
  • step S3 the reader 10 reads a reference status of the membrane 40 by using the first reading unit 15.
  • the first reading unit 15 of the reader 10 detects the arrival of the feces solution of the specimen that drips, in step S2, penetrates to the membrane 40, is directed to the downstream side, and is at a reference position that is the predetermined position of the cartridge housing unit 12 and the change of the reference status of the membrane 40 at the reference position from an impenetrated status to a penetrated status. After detecting the change of the reference status, the first reading unit 15 notifies the processing unit 21 of the detection.
  • the processing unit 21 recognizes that, for example, the feces solution of the specimen has already been dripped, and controls the display unit 25 so as to turn off the light of the display subarea of the droplet symbol of the second display 14 that makes the notification that the feces solution of the specimen is in a status of readiness to be dripped.
  • step S4 the reader 10 sets the timer 23.
  • the processing unit 21 of the reader 10 controls the timer 23 to start measuring a predetermined time.
  • the predetermined time is a time during which the feces solution of the specimen is penetrated from the reference position to the detection position, and the predetermined time is set in advance to the memory unit 24 of the reader 10.
  • the followings are taken as examples: 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430 ,440, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, and 600 seconds, and 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and 30 minutes.
  • the time measured by the timer 23 is transmitted from the processing unit 21 to the tablet 50 via the interface 26, and the tablet 50 that has received the time from the interface 55 may display a remaining time of the timer 23 on the display 53.
  • the processing unit 21 may control the display unit 25 so as to represent that the timer 23 is in the middle of measuring the time by turning on the light of the display subarea drawn with the clock symbol of the second display area 14 of the reader 10.
  • step S5 the reader 10 reads the detection status of the membrane 40 by using the second reading unit 16.
  • step S4 in a case where the time whose measurement is started reaches a predetermined time, the timer 23 of the reader 10 notifies the processing unit 21 of the result.
  • the processing unit 21 controls the second reading unit 16 to read a coloration of the detection position of the membrane 40.
  • the second reading unit 16 of the reader 10 detects, as a detection status, the coloration intensity of the test line 44 at the detection position that is a position corresponding to a position immediately above the test line 44 of the membrane 40 in the cartridge housing unit 12, and notifies the processing unit 21 of the detection result.
  • the second reading unit 16 may notify the processing unit 21 of the detection result after, for example, transforming data of the coloration intensity detected by a photodiode as the current to digital data by using an analog-digital converter.
  • the processing unit 21 stores data of the detection status detected by the second reading unit 16 in the memory unit 24. Further, the processing unit 21 may transmit the detection status to the tablet 50 via the interface 26.
  • the processing unit 21 may control the display unit 25 so as to represent that the measurement of the time by the timer 23 has ended by turning off the light of the display subarea drawn with the clock symbol of the second display area 14 of the reader 10.
  • step S6 the reader 10 applies a predetermined transformation to the data of the detection status.
  • the processing unit 21 of the reader 10 reads, from the memory unit 24, the data of the coloration intensity as the detection status received from the second reading unit 16, applies the predetermined processing to the data, and transforms the data to the data of the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like.
  • the data of the coloration intensity may be decided that the hemoglobin is detected and the result of the fecal occult blood test is decided as positive, and alternatively, in a case where the data of the coloration intensity does not exceed the threshold value, it may be decided that the hemoglobin has not been detected and the result of the fecal occult blood test may be decided as negative. Further, by referring to a predetermined standard curve, the data of the coloration intensity may be transformed to the data of the hemoglobin content.
  • the processing unit 21 stores, in the memory unit 24, and also transmits to the table 50, via the interface 26, the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like that has been subjected to the transformation.
  • the processing unit 21 may transmit the data of the coloration intensity as the detection status to the tablet 50 together with or instead of the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like.
  • the processing unit 21 may not only transmit the data to the tablet 50 but also may store the data in the server 111 in the cloud 110.
  • the processing unit 21 controls the display unit 25 so as to display the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test by turning on the light of the display subarea drawn with a“+” symbol or a symbol of the first display area 13.
  • the tablet 50 After receiving, from the reader 10 via the interface 55, the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like, the tablet 50 stores the data in the memory unit 52 and displays the data on the display 53.
  • the processing unit 51 of the tablet 50 may apply the predetermined processing to the data of the detection status and transform the data to the data including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like.
  • the transformation performed by the processing unit 51 of the tablet 50 may be the same/ different to/from the transformation performed by the processing unit 21 of the reader 10.
  • step S2 in a case where the memory unit 52 stores a created table in which the identification data of the test subject is associated with the identification data of the cartridge 30, the processing unit 51 of the tablet 50 may control the display 53 to display the analysis result of the fecal occult blood test together with the data of the test subject by referring to the table.
  • the processing unit 51 of the tablet 50 by similarly referring to the table stored in the server 111 in the cloud 110, may control the display 53 to display the analysis result of the fecal occult blood test together with the data of the test subject.
  • the processing unit 21 of the reader 10 may control the display unit 25 so as to make the notification that the fecal occult blood test has ended by turning off the light of the display subarea drawn with the droplet symbol of the second display area 14.
  • step SI After a series of steps of the fecal occult blood test from step SI to step S6 end, the users remove the cartridge 30 set to the reader 10 from the reader 10.
  • the cartridge detection sensor 17 detects the removal of the cartridge 30, and on the contrary to the process in step SI, the power source of the reader 10 is turned off and a mode is shifted to the standby mode in which the electric power consumption is suppressed.
  • another cartridge 30 is set to the reader 10. This causes a series of steps at or after step SI to be restarted.
  • the processing unit 51 of the tablet 50 may store, in the server 111 in the cloud 110, the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like that has been stored in the memory unit 52.
  • the server in the cloud 110 may store the data of the coloration intensity as the detection status that is not transformed to the data of the analysis result of the fecal occult blood test.
  • the tablet 50 and the personal computer 60 present in a spot different from the testing spot in the clinic 102 may read the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like and the data of the coloration intensity not being transformed to the data of the analysis result of the fecal occult blood test, that have been stored in the server 111 in the cloud 110.
  • the reader 10 manages a time necessary for measuring the detection status. Accordingly, the burden of users can be reduced and also the precision of the analysis can be enhanced because the time management by users such as doctors or nurses who conduct the fecal occult blood test is not necessary. Further, the coloration intensity of the membrane 40 is read by using the second reading unit 16 of the reader 10. Accordingly, based on the coloration intensity, a quantitative analysis of the fecal occult blood test can be performed promptly on site.
  • the reader 10 and the tablet 50 are used in a cooperated manner, and an updated status of the reader 10 and the analysis result of the fecal occult blood test are set to be immediately reflected to the display 53 of the tablet 50.
  • the users who conduct the fecal occult blood test can operate the reader 10 and the cartridge 30 by referring to the display 53 of the tablet 50. Accordingly, the operating efficiency can be raised and the burden of the users can be reduced.
  • the reader 10 and the tablet 50 can store the data of the analysis result of the fecal occult blood test including the positive result or the negative result of the fecal occult blood test, the hemoglobin content and the like and the data of the coloration intensity as the detection status, in the server 111 in the cloud 110 via the network. Accordingly, a new insight can be gained by causing by the data to be interfaced with big data such as the patient history data 120 or the market information 130.
  • the reader 10 can be sold as a disposable reader as a set combined with the predetermined number of cartridges 30. It is sufficient if the reader 10 possesses the durability that enables reading of the predetermined number of cartridges 30 and the repairs of the failure, the calibration and the like are not necessary. Accordingly, the reliability of the reader 10 can be improved and also the cost of the reader 10 can be reduced. [0084] In the present embodiment, only a single test line 44 is formed to the membrane 40 incorporated in the cartridge 30, but the number of the test line 44 is not limited to one and a plurality of test lines 44 may be formed.
  • the present disclosure can be used for the screening test (the fecal occult blood test) conducted for the bleeding from the lower digestive tract caused by a bowel cancer and the like.

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Abstract

L'invention concerne un lecteur 10 qui utilise une cartouche 30 servant à effectuer un test de sang occulte dans les selles, dans laquelle est incorporée une membrane d'immunochromatographie 40, comprenant : une unité de logement de cartouche 12 ayant une position de référence et une position de détection; une première unité de lecture 15 disposée à la position de référence et effectuant la lecture d'un état de référence de la membrane 40; une seconde unité de lecture disposée à la position de détection et effectuant la lecture d'un état de détection de la membrane; une minuterie 23 qui mesure un temps qui s'écoule à partir d'un instant où l'état de référence de la membrane est modifié; et une unité de traitement 21 qui transforme de manière prédéterminée l'état de détection lu par la seconde unité de détection à un temps prédéterminé sur la base de la minuterie 23 pour produire les données transformées.
PCT/IB2020/000612 2019-07-23 2020-07-23 Lecteur d'immunochromatographie, système d'immunochromatographie et méthode de détection d'hémoglobine WO2021014216A1 (fr)

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1183745A (ja) * 1997-09-10 1999-03-26 Matsushita Electric Ind Co Ltd 排泄物成分検査装置
WO2004070353A2 (fr) * 2003-01-30 2004-08-19 Mizuho Usa Inc. Procede et dispositif pour le traitement de resultats de tests d'analyse
WO2013158505A1 (fr) * 2012-04-17 2013-10-24 Ehrenkranz Joel R L Dispositif pour effectuer un test diagnostique à base d'enzyme et procédés pour l'utilisation de celui-ci
JP2014006269A (ja) 2013-10-17 2014-01-16 Arkray Inc イムノクロマトグラフィ装置
US9417235B2 (en) * 2008-11-20 2016-08-16 Arkray, Inc. Optical measurement apparatus
WO2017127349A1 (fr) * 2016-01-18 2017-07-27 Jana Care, Inc. Analyseur de test d'analytes multiples à dispositif mobile à utiliser pour la surveillance et le criblage de diagnostic médical
US20180188170A1 (en) * 2003-06-04 2018-07-05 Alere Switzerland Gmbh Assay devices and methods
US20190187139A1 (en) * 2016-06-22 2019-06-20 Becton, Dickinson And Company Modular assay reader device

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH1183745A (ja) * 1997-09-10 1999-03-26 Matsushita Electric Ind Co Ltd 排泄物成分検査装置
WO2004070353A2 (fr) * 2003-01-30 2004-08-19 Mizuho Usa Inc. Procede et dispositif pour le traitement de resultats de tests d'analyse
US20180188170A1 (en) * 2003-06-04 2018-07-05 Alere Switzerland Gmbh Assay devices and methods
US9417235B2 (en) * 2008-11-20 2016-08-16 Arkray, Inc. Optical measurement apparatus
WO2013158505A1 (fr) * 2012-04-17 2013-10-24 Ehrenkranz Joel R L Dispositif pour effectuer un test diagnostique à base d'enzyme et procédés pour l'utilisation de celui-ci
JP2014006269A (ja) 2013-10-17 2014-01-16 Arkray Inc イムノクロマトグラフィ装置
WO2017127349A1 (fr) * 2016-01-18 2017-07-27 Jana Care, Inc. Analyseur de test d'analytes multiples à dispositif mobile à utiliser pour la surveillance et le criblage de diagnostic médical
US20190187139A1 (en) * 2016-06-22 2019-06-20 Becton, Dickinson And Company Modular assay reader device

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