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WO2013070032A1 - Système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses, et procédé associé - Google Patents

Système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses, et procédé associé Download PDF

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Publication number
WO2013070032A1
WO2013070032A1 PCT/KR2012/009487 KR2012009487W WO2013070032A1 WO 2013070032 A1 WO2013070032 A1 WO 2013070032A1 KR 2012009487 W KR2012009487 W KR 2012009487W WO 2013070032 A1 WO2013070032 A1 WO 2013070032A1
Authority
WO
WIPO (PCT)
Prior art keywords
bone
osteoporosis
cartridge
bone turnover
light
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2012/009487
Other languages
English (en)
Korean (ko)
Inventor
이상대
김경식
백준흠
김은정
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
IM HEALTHCARE CO Ltd
Original Assignee
IM HEALTHCARE 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.)
Filing date
Publication date
Application filed by IM HEALTHCARE CO Ltd filed Critical IM HEALTHCARE CO Ltd
Priority claimed from KR1020120126709A external-priority patent/KR20130051428A/ko
Publication of WO2013070032A1 publication Critical patent/WO2013070032A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/475—Assays involving growth factors
    • G01N2333/51—Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/10—Musculoskeletal or connective tissue disorders
    • G01N2800/108—Osteoporosis

Definitions

  • the present invention relates to a system and method for diagnosing osteoporosis and bone turnover rate.
  • the diagnosis of osteoporosis and bone turnover rate using the conventional bone markers is mainly dependent on biochemistry, and usually takes the Enzyme-Linked Immunosorbent Assay (ELISA) method.
  • ELISA Enzyme-Linked Immunosorbent Assay
  • the bone marker can be quantified.
  • the result can be obtained through various spectral analysis and calibration curve.
  • the present invention is to provide a system and method for diagnosing osteoporosis and bone turnover rate using a bone marker.
  • the osteoporosis and bone turnover diagnostic system An insertion unit into which a cartridge reacting the bone markers included in the blood and urination of the patient is inserted, a light emitting unit for irradiating light to the control line and the test line, and a light receiving unit collecting light reflected from the control line and the test line And a controller configured to detect the bone marker by measuring the reaction degree based on the amount of light collected by the light receiver.
  • the cartridge may include a sample port for injecting blood and urination samples collected from a patient, and a control line and a test line in which a degree of response between the antigen and the antibody is displayed.
  • the antigen may comprise a gold nano-particle antibody.
  • the bone markers may include NTX (N-terminal telopeptide), CX (CTx, C-terminal telopeptide), and OC (Osteocalcin).
  • the cartridge is produced for each of the bone markers, and includes a bar code or QR code containing information indicating a corresponding bone marker on one side, and the control unit is connected to an external reader that recognizes the barcode or QR code
  • the bone marker of the cartridge may be identified through information recognized by an external reader.
  • a method for diagnosing osteoporosis and bone turnover may include inserting a cartridge in which a bone marker and gold marker included in the blood and urination of the patient reacted, and antibody in the cartridge using optical technology. And measuring a degree of response between antigens, and detecting a bone marker for diagnosing osteoporosis and bone turnover rate based on the result of the measurement of the degree of response.
  • the measuring may include irradiating light to a control line and a test line showing a degree of reaction between the antigen and the antibody, collecting light reflected from the control line and the test line, and collecting the collected light amount. Based on the reaction degree may be measured.
  • the reacting step further comprising the step of identifying from the external reader the bone markers included in the barcode or QR code included in one side of the cartridge recognized by the external reader,
  • the detecting may detect the identified bone marker.
  • osteoporosis and bone turnover treatment may help in selecting a medicine, and monitoring for osteoporosis and bone turnover treatment is possible.
  • a low cost cartridge when diagnosing the bone turnover rate can be a regular inspection, it may be possible to determine the presence of disease and quantitative determination of the extent of symptoms.
  • FIG. 1 is a schematic diagram of a system for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • FIG. 2 is a view schematically showing a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • FIG. 3 is a block diagram of a osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention.
  • Figure 4 is an exploded side perspective view of the osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention.
  • FIG. 5 is a schematic internal configuration of the osteoporosis and bone turn rate diagnostic apparatus according to an embodiment of the present invention.
  • FIG. 6 is a block diagram of an optical system for diagnosing osteoporosis and bone turnover according to an embodiment of the present invention.
  • Figure 7 shows the measuring principle of the osteoporosis and bone turnover diagnostic according to an embodiment of the present invention.
  • FIG. 8 is a flowchart illustrating a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • ... unit described in the specification means a unit for processing at least one function or operation, which may be implemented in hardware or software or a combination of hardware and software.
  • FIG. 1 is a schematic diagram of a system for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • an osteoporosis and bone turnover diagnostic system includes an osteoporosis and bone turnover diagnostic apparatus 100 and a cartridge 200.
  • the osteoporosis and bone turnover diagnostic system uses human blood and urination as specimens. And antigen-antibody reactions against gold nano-particles (Gold nano-particles) of a randomly set wavelength range.
  • the cartridge 200 may be manufactured separately for specific bone markers for diagnosing osteoporosis and bone turnover rate. That is, it may be separately manufactured to measure NT-terminal telopeptide (NTx), C-terminal telopeptide (CTx), and osteocalcin (OC).
  • NTx NT-terminal telopeptide
  • C-terminal telopeptide CTx
  • osteocalcin OC
  • a barcode or QR code may be attached to one side of the cartridge 200 to include measurement marker information of the cartridge 200.
  • the osteoporosis and bone turn rate diagnostic apparatus 100 may be connected to a reader unit (not shown) capable of reading a barcode or a QR code of the cartridge 200.
  • the cartridge 200 may be a lateral flow immunochromatography. And the reaction time can be different depending on the sample.
  • osteoporosis and bone turnover diagnostic systems are lateral flow systems using antigen and antibody responses.
  • it is an immunodiagnostic kit for detecting biochemical markers of three species, namely NTx, CTx, and OC using trace amounts of blood and urination.
  • POCT point of care
  • FIG. 2 is a view schematically showing a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • the cartridge 200 is injected into the blood and urination through the collector 300, and then inserted into the osteoporosis and bone turn rate diagnostic apparatus 100.
  • Osteoporosis and bone turnover rate diagnosis device 100 diagnoses osteoporosis and bone turnover rate by measuring the antigen antibody response of blood and urination collected by the cartridge 200 using an optical system.
  • FIG. 3 is a configuration diagram of the osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention, showing a state equipped with a diagnostic strip.
  • the cartridge 200 includes a control line 201 and a test line 203 for measuring the antigen-antibody response, and a sample port for injecting urine and blood. (sample port) 205.
  • the control line 201 and the test line 203 are the configuration of the diagnostic strip.
  • the control line 201 and the test line 203 are integrated with antibodies.
  • the conjugate pad 209 of the diagnostic strip is integrated with gold nano-particle antibodies.
  • the gold nado-particles react with the blood and urine injected through the sample port 205, and the degree of response is displayed on the control line 201 and the test line 203.
  • Figure 4 is an exploded side perspective view of the osteoporosis and bone turnover diagnostic cartridge according to an embodiment of the present invention.
  • the diagnostic strip mounted on the cartridge 200 may include a control line 201, a test line 203, a sample port 205, a sample pad 207, and a conjugate pad. 209, a membrane 211, an absorbent pad 213, and the cartridge includes a housing 215 on which the diagnostic strip is mounted.
  • control line 201 and the test line 203 is formed on the membrane 211.
  • the sample pad 207 is positioned below the sample port 205.
  • the sample pad 207 and the membrane 211 sandwich the conjugate pad 209.
  • An absorbent pad 213 is attached to the rear end of the membrane 211.
  • FIG. 5 is a schematic internal configuration diagram of an osteoporosis and bone turnover diagnosis device according to an embodiment of the present invention
  • FIG. 6 is an optical system diagram of an osteoporosis and bone turnover diagnosis device according to an embodiment of the present invention
  • FIG. The measuring principle of the osteoporosis and bone turn rate diagnostic apparatus according to the embodiment is shown.
  • the osteoporosis and bone turn rate diagnostic apparatus 100 includes an insertion unit 101, a light emitting unit 103, a light receiving unit 105, a control unit 107, a liquid crystal display (LCD) 109, a power supply. And a supply unit 111, a battery 113, and a commercial power input unit 115.
  • the insertion unit 101 provides a space in which the cartridge 200 can be inserted so that the cartridge 200 is inserted and fixed.
  • the insertion unit 101 may be implemented as a configuration means for mounting a sensor (not shown) that determines whether the cartridge 200 is inserted, and automatically transfers the cartridge 200 to the measurement point.
  • the osteoporosis and bone turnover rate diagnosis device 100 includes a light emitting unit 103 and a light receiving unit 105 to perform diagnosis of osteoporosis and bone turnover rate using urination and blood using an optical system.
  • the optical system may be configured as an active optical system for auto focus imaging in designing an optical system for optical scanning.
  • the light emitter 103 irradiates light to the control line 201 and the test line 203 of the cartridge 200.
  • the light emitting unit 103 may be a green laser diode (LD).
  • the light receiver 105 collects light reflected from the control line 201 and the test line 203.
  • the light receiving unit 105 may be a photo diode IC (PDIC) to which an amplification circuit is applied.
  • the light emitting unit 103 and the light receiving unit 105 may use a specific wavelength band, for example, gold nano-particles of 532 nm.
  • the optical system structure of the osteoporosis and bone turnover rate analyzer 100 is shown in FIG. That is, the light emitting unit 103, the light receiving unit 105, and three lenses 117 are included.
  • the first lens 117-1 is positioned at the lower end of the light emitting unit 103 to transmit the light irradiated toward the cartridge 200.
  • the second lens 117-2 and the third lens 117-3 are positioned at the lower end of the light receiving unit 105 to transmit the reflected light.
  • the optical system principle of the osteoporosis and bone turn rate diagnostic apparatus 100 is as shown in FIG. That is, the light irradiated by the laser diode (LD) 103 is reflected by the control line 201 and the test line 203 of the cartridge 200 and collected by the photodiode IC (PDIC) 105.
  • LD laser diode
  • PDIC photodiode IC
  • the controller 107 measures the amount of light collected by the light receiving unit 105 or the photodiode IC (PDIC) 105 and compares the result of the osteoporosis and bone turnover rate measurement with an LCD. 109).
  • PDIC photodiode IC
  • the LCD 109 may be implemented as a user interface (UI) designed in consideration of the convenience of the user (medical agent and medical inspector).
  • UI user interface
  • the controller 107 measures the antigen-antibody reaction result for the gold nanoparticles based on the amount of light.
  • the degree of antigen antibody response in the control line 201 may be measured by a predetermined time unit to determine the antigen antibody reaction in the cartridge 200 and the test line measurement may be performed. In this case, the test line may be measured and corrected based on the control line 201 to obtain a result value.
  • the power supply 111 supplies power to the controller 107 and is connected to the battery 113 and the commercial power input 115 to receive power and provide the power to the controller 107.
  • FIG. 8 is a flowchart illustrating a process for diagnosing osteoporosis and bone turnover rate in accordance with an embodiment of the present invention.
  • the cartridge 200 injecting blood and urination of the patient is inserted into the insertion unit 101 of the osteoporosis and bone turnover rate analyzer 100 (S101).
  • An external reader (not shown) connected to the osteoporosis and bone turn rate diagnosis apparatus 100 reads a barcode or QR code printed on the surface of the cartridge 200 (S103).
  • the barcode or QR code includes information indicating whether the measurement indicator of the cartridge 200 is NTx, CTx, or OC. Therefore, the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 confirms the measurement marker based on the information read through step S103 (S105).
  • the osteoporosis and bone turn rate diagnostic apparatus 100 is in a standby state until the reaction in the cartridge 200 is made (S107).
  • the blood injected into the sample port 205 of the cartridge 200 and the antigen contained in the urine are in a waiting state to react with the antibodies accumulated in the control line 201 and the test line 203.
  • the optical system of the osteoporosis and bone turn rate diagnostic apparatus 100 measures the control line 201 (S109) to determine whether the chemical reaction is completed (S111).
  • the light emitting unit 103 of the osteoporosis and bone turnover rate diagnosis apparatus 100 determines the completion of the chemical reaction by measuring the amount of light reflected from the control line 201. For example, three minutes after the cartridge 200 is inserted, the control line 201 is measured to determine whether the chemical reaction is completed.
  • step S107 if the chemical reaction is not completed, starting from step S107.
  • the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 measures and corrects the test line 203 based on the result measured in the control line 201 to obtain a result value.
  • the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 first measures the amount of light reflected from the control line 201 and compares it with a predefined threshold value. Based on the comparison result, the controller 107 measures the antigen-antibody reaction result for the gold nanoparticles (S113). For example, the numerical values of NTx, CTx, and OC may be mapped and stored for each threshold of light quantity.
  • control unit 107 of the osteoporosis and bone turnover rate diagnosis apparatus 100 may measure the antigen-antibody reaction result by measuring and correcting the amount of light reflected from the test line 203 based on the value measured in the control line. At this time, the reaction time can be confirmed by the test line 203 and repeated measurement is also possible.
  • the insertion unit 101 protrudes the cartridge 200 (S115).
  • the control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 determines whether the new cartridge 200 is inserted into the insertion unit 101 (S117). In other words, it is determined whether there is an additional measurement.
  • step S101 if there is an additional measurement, it starts again from step S101.
  • control unit 107 of the osteoporosis and bone turn rate diagnostic apparatus 100 outputs the measurement result of the degree of antigen antibody response of the control line and the test line through the display unit 109 (S119).
  • the embodiments of the present invention described above are not only implemented through the apparatus and the method, but may be implemented through a program for realizing a function corresponding to the configuration of the embodiments of the present invention or a recording medium on which the program is recorded.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Food Science & Technology (AREA)
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  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

L'invention concerne un système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses, et un procédé associé. Le système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses comprend: une partie d'insertion dans laquelle est insérée une cartouche ayant réagi avec un marqueur osseux présent dans le sang ou l'urine d'un patient; une partie électroluminescente pour irradier de la lumière sur une ligne de contrôle et une ligne de test; une partie réceptrice de lumière pour recueillir la lumière réfléchie par la ligne de contrôle et la ligne de test; et une partie de contrôle pour mesurer le degré de réaction en fonction de la quantité de lumière recueillie par la partie réceptrice de lumière, et détecter le marqueur osseux.
PCT/KR2012/009487 2011-11-09 2012-11-09 Système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses, et procédé associé Ceased WO2013070032A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2011-0116571 2011-11-09
KR20110116571 2011-11-09
KR10-2012-0126709 2012-11-09
KR1020120126709A KR20130051428A (ko) 2011-11-09 2012-11-09 골다공증 및 골회전율 진단 시스템 및 그 방법

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WO2013070032A1 true WO2013070032A1 (fr) 2013-05-16

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PCT/KR2012/009487 Ceased WO2013070032A1 (fr) 2011-11-09 2012-11-09 Système de diagnostic de l'ostéoporose et du taux de renouvellement des cellules osseuses, et procédé associé

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5965136A (en) * 1992-12-28 1999-10-12 Baylink; David J. Bone resorption assay
KR100934286B1 (ko) * 2008-01-04 2009-12-28 경북대학교병원 골다공증 예측용 다형성 마커 및 이를 이용한 골다공증예측 방법
KR20100137092A (ko) * 2009-06-22 2010-12-30 주식회사 메디칼써프라이 광을 이용한 골다공증 측정 방법 및 장치
KR20110051891A (ko) * 2009-11-11 2011-05-18 전자부품연구원 골다공증 진단용 배뇨 분석 장치 및 방법

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5965136A (en) * 1992-12-28 1999-10-12 Baylink; David J. Bone resorption assay
KR100934286B1 (ko) * 2008-01-04 2009-12-28 경북대학교병원 골다공증 예측용 다형성 마커 및 이를 이용한 골다공증예측 방법
KR20100137092A (ko) * 2009-06-22 2010-12-30 주식회사 메디칼써프라이 광을 이용한 골다공증 측정 방법 및 장치
KR20110051891A (ko) * 2009-11-11 2011-05-18 전자부품연구원 골다공증 진단용 배뇨 분석 장치 및 방법

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