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WO2018143684A1 - Système de lieu d'intervention et procédé de diagnostic de maladie fébrile aiguë - Google Patents

Système de lieu d'intervention et procédé de diagnostic de maladie fébrile aiguë Download PDF

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Publication number
WO2018143684A1
WO2018143684A1 PCT/KR2018/001369 KR2018001369W WO2018143684A1 WO 2018143684 A1 WO2018143684 A1 WO 2018143684A1 KR 2018001369 W KR2018001369 W KR 2018001369W WO 2018143684 A1 WO2018143684 A1 WO 2018143684A1
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WO
WIPO (PCT)
Prior art keywords
diagnostic
diagnostic kit
raman
detecting
disease
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/KR2018/001369
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English (en)
Korean (ko)
Inventor
정두련
강민희
이남용
이민영
이규성
주재범
이상엽
황준기
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.)
Industry University Cooperation Foundation IUCF HYU
Samsung Life Public Welfare Foundation
Original Assignee
Industry University Cooperation Foundation IUCF HYU
Samsung Life Public Welfare Foundation
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 Industry University Cooperation Foundation IUCF HYU, Samsung Life Public Welfare Foundation filed Critical Industry University Cooperation Foundation IUCF HYU
Priority to US16/483,195 priority Critical patent/US11366065B2/en
Priority to CN201880022848.0A priority patent/CN110546484A/zh
Priority claimed from KR1020180012663A external-priority patent/KR102047989B1/ko
Publication of WO2018143684A1 publication Critical patent/WO2018143684A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/65—Raman scattering
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood

Definitions

  • the present invention relates to a system and method for diagnosing acute febrile disease, and more particularly, to a system and method for accurately and quickly diagnosing various kinds of autumn acute febrile disease.
  • Representative acute febrile diseases in the fall season include Tsutsugamus, Leptospirosis, Rash Fever, Nephrotic Syndrome Hemorrhagic Fever.
  • a common symptom of these disorders is a fever that accompanies symptoms such as cold.
  • Fall acute febrile illnesses can lead to complications and, in severe cases, it is important that the patient die and receive appropriate treatment as soon as possible.
  • the present invention has been made to solve the above problems, an object of the present invention is to accurately and quickly identify various acute recessive diseases to improve the efficiency of the on-site diagnosis.
  • the on-site diagnostic system for solving the technical problem is a diagnostic reagent for detecting a target antigen based on an aptamer, a diagnostic device for detecting a Raman signal through a Raman analysis technique, and a lateral flow method based on a diagnostic device.
  • a diagnostic kit for detecting a target antigen based on an aptamer
  • a diagnostic device for detecting a Raman signal through a Raman analysis technique
  • a lateral flow method based on a diagnostic device.
  • a Raman analysis performing unit a disease analyzing unit analyzing the type of acute recessive disease in which the subject is infected according to the detected Raman signal, and an output unit outputting information on the analyzed disease.
  • the diagnostic reagent includes an aptamer for detecting an antigen and a fixed aptamer, and can directly detect an antigen in blood injected into a diagnostic kit.
  • the diagnostic kit seating unit may include at least one of a pressure sensor, an optical sensor, and an electric signal transmitting / receiving means for detecting that the diagnostic kit is disposed.
  • the Raman analysis performer can detect the Raman signal by amplifying the surface enhanced Raman scattering (SERS) technique and gold-silver nanoparticles.
  • SERS surface enhanced Raman scattering
  • the output unit may include a display unit for visually providing information about a disease and a speaker for providing audio information.
  • the on-site diagnostic method for solving the technical problem is a step of detecting that the diagnostic kit for operating the lateral flow method of the diagnostic device for detecting the Raman signal is disposed through the Raman analysis technique, if it is detected that the diagnostic kit is arranged, Detecting the Raman signal generated by reacting the blood injected into the diagnostic kit with the aptamer-based diagnostic reagent, detecting the antigen by analyzing the Raman signal, and detecting the antigen according to the detected antigen. Identifying the type, and outputting information about the analyzed disease.
  • POCT point of care testing
  • 1A is a diagram illustrating a conventional fall acute recessive disease diagnosis method associated with the proposed embodiment.
  • Figure 1b is a diagram showing the change in the concentration of serum IgM, IgG according to the test time.
  • FIG. 2 is a view schematically showing a field diagnosis system according to a proposed embodiment.
  • FIG. 3 is a block diagram illustrating a configuration of a diagnostic device of an on-site diagnosis system according to an exemplary embodiment of the present disclosure.
  • FIG. 4 is a view for explaining a diagnostic reagent of the on-site diagnostic system according to the embodiment.
  • FIG. 5 is a view for explaining a diagnostic kit of the on-site diagnostic system according to an embodiment.
  • FIG. 6 is a flowchart illustrating an on-site diagnosis method according to an exemplary embodiment.
  • the on-site diagnostic system for solving the technical problem is a diagnostic reagent for detecting a target antigen based on an aptamer, a diagnostic device for detecting a Raman signal through a Raman analysis technique, and a lateral flow method based on a diagnostic device.
  • a diagnostic kit for detecting a target antigen based on an aptamer
  • a diagnostic device for detecting a Raman signal through a Raman analysis technique
  • a lateral flow method based on a diagnostic device.
  • a Raman analysis performing unit a disease analyzing unit analyzing the type of acute recessive disease in which the subject is infected according to the detected Raman signal, and an output unit outputting information on the analyzed disease.
  • the diagnostic reagent includes an aptamer for detecting an antigen and a fixed aptamer, and can directly detect an antigen in blood injected into a diagnostic kit.
  • the diagnostic kit seating unit may include at least one of a pressure sensor, an optical sensor, and an electric signal transmitting / receiving means for detecting that the diagnostic kit is disposed.
  • the Raman analysis performer can detect the Raman signal by amplifying the surface enhanced Raman scattering (SERS) technique and gold-silver nanoparticles.
  • SERS surface enhanced Raman scattering
  • the output unit may include a display unit for visually providing information about a disease and a speaker for providing audio information.
  • the on-site diagnostic method for solving the technical problem is a step of detecting that the diagnostic kit for operating the lateral flow method of the diagnostic device for detecting the Raman signal is disposed through the Raman analysis technique, if it is detected that the diagnostic kit is arranged, Detecting the Raman signal generated by reacting the blood injected into the diagnostic kit with the aptamer-based diagnostic reagent, detecting the antigen by analyzing the Raman signal, and detecting the antigen according to the detected antigen. Identifying the type, and outputting information about the analyzed disease.
  • any part of the specification is to “include” any component, this means that it may further include other components, except to exclude other components unless otherwise stated.
  • the terms “... unit”, “module”, etc. described in the specification mean 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. .
  • a part of the specification is “connected” to another part, this includes not only “directly connected”, but also “connected with other elements in the middle”.
  • an on-site diagnostic system for diagnosing acute febrile disease is a co-prompt diagnosis of multiple targets of antigens, antibodies (IgG, IgM) and Raman signals using a Raman diagnostic reagent and a small Raman analyzer.
  • High-sensitivity and quantitative analysis through amplification have the advantage of improving diagnostic criteria and test accuracy.
  • Figure 1a is a diagram showing a conventional fall acute recessive disease diagnosis method associated with the proposed embodiment
  • Figure 1b is a view showing the change in the concentration of serum IgM, IgG according to the test time.
  • Tsutsugamus As a representative fall acute recessive disease, Tsutsugamus, Leptospirosis, Rash fever and Nephrotic syndrome hemorrhagic fever have been described as an example. These acute recessive diseases are increasing in frequency due to the increase in outdoor activities in autumn, and the distribution of incidence is also increasing due to rising national temperatures in autumn.
  • IFA indirect immunofluorescent antibody test
  • ICA immunochromatography
  • PCR polymerase chain reaction
  • FIG. 2 is a view schematically showing a field diagnosis system according to a proposed embodiment.
  • the on-site diagnostic system according to the proposed embodiment includes a diagnostic reagent (FIG. 2 (a)), a diagnostic kit (FIG. 2 (b)), and a diagnostic device (FIG. 2 (c)).
  • the on-site diagnostic system shown is a system for rapid and accurate diagnosis in the field, and includes an aptamer based diagnostic reagent, a Raman analysis based high sensitivity lateral flow diagnostic kit, and a miniaturized Raman analysis instrument as element technology. Is implemented.
  • the aptamer is a polymer material having a three-dimensional binding property with a target protein
  • the aptamer-based diagnostic reagent (FIG. 2 (a)) binds to the target antigen with high specificity and affinity.
  • serological methods have been relied on to diagnose autumn diseases (Tsutsugamosis, Leptospirosis, Rash, Renal Syndrome, Hemorrhagic Fever, etc.), and serological methods do not detect pathogens themselves. It took essentially seven to seven days.
  • aptamer-based diagnostic reagents can detect pathogens (ie, antigens) themselves and do not have to wait for the production of antibodies. The time to wait is reduced, enabling real-time diagnosis of the disease.
  • the aptamer-based diagnostic reagent has the advantage of directly detecting the antigen in the blood, unlike the conventional method of detecting the antibody indirectly for antigen detection. Promptness can be ensured.
  • the aptamer-based diagnostic reagent to the Raman analysis technique to be described later, it is possible to diagnose a high specificity to minimize cross-reaction.
  • the proposed diagnostic kit is based on a lateral flow assay analysis technique.
  • the diagnostic kit using lateral flow is very suitable for on-site diagnosis because it can quickly diagnose a disease with only one or two drops of blood.
  • diagnostic kits using lateral flow analysis techniques are advantageous in terms of analysis cost and do not require professional personnel.
  • This lateral flow based diagnostic kit utilizes the capillary forces of paper resulting from the high density volume, hydrophilic environment, and micro / nano pores resulting from the three-dimensional hierarchical structure of the cellulose fiber network.
  • Raman analysis method is suitable for field diagnostic equipment because it requires less power than fluorescence diagnostic method.
  • the Raman analysis technique has a sensitivity that is several tens of times or more than the conventional immune-based diagnostic method has the advantage of obtaining a high sensitivity diagnostic results.
  • the portability can be improved to improve the suitability to the POCT.
  • the on-site diagnostic system consisting of the above-described aptamer-based diagnostic reagents, lateral flow-based diagnostic kits, and Raman analysis-based diagnostic instruments enables the diagnosis of high specificity and high sensitivity to acute recessive diseases.
  • in situ diagnostic systems are particularly important for their specificity and sensitivity, as well as their rapidity.As mentioned above, aptamer-based reagents, lateral flow-based diagnostic kits, and Raman analysis-based diagnostic instruments are integrated into the site in a timely manner. The diagnostic system utilized may be implemented.
  • FIG. 3 is a block diagram illustrating a configuration of a diagnostic device of an on-site diagnostic system according to an exemplary embodiment
  • FIG. 7 is a diagram illustrating a Raman signal analysis result for (a) a positive sample and (b) a negative sample.
  • the diagnostic device 1000 will be described in detail among diagnostic reagents, diagnostic kits, and diagnostic devices configuring the proposed on-site diagnostic system.
  • the diagnostic device 1000 may include a diagnostic kit seating unit 110, a Raman analysis performing unit 120, a disease analysis unit 130, an output unit 140, a communication unit 150, a memory 160, It is composed of the power supply unit 170, the control unit 180, but is not limited to such a configuration, it may be implemented by including a further general configuration or fewer configurations.
  • the diagnostic kit seating unit 110 is a member in which the diagnostic kit is disposed, and detects that the diagnostic kit into which the blood of the examinee is placed is placed on the diagnostic device.
  • the diagnostic kit seating unit 110 may detect an arrangement of the diagnostic kit by using a predetermined sensor. For example, a pressure sensor, an optical sensor, or the like may be used to detect that the diagnostic kit is disposed in the diagnostic device 1000. Can be.
  • the diagnostic kit seating unit 110 may detect that the diagnostic kit is disposed by exchanging an electrical signal with the diagnostic kit.
  • the Raman analysis performing unit 120 performs a Raman analysis on blood introduced into the diagnostic kit as the diagnostic kit seating unit 110 detects that the diagnostic kit is disposed.
  • SERS Surface Enhanced Raman Scattering
  • the Raman signal may be obtained by measuring the Raman intensity ratio by polynomial fitting after multi-line scan. This scan can be performed continuously from the Control (C) line to the Test (T) line.
  • signals of a control line (CL) and a test line (TL) of the diagnostic kit may appear.
  • (a) is the analysis result of the positive sample
  • (b) is the analysis result of the negative sample.
  • Positive / negative can be determined by the ratio of the Raman signals of the control and test lines.
  • the Raman analysis performing unit 120 analyzes the Raman signal amplified by the composite nanoparticles such as gold, silver nanoparticles, and gold (core) -silver (shell), and then amplifies the signal once more using a silver structure to quantify high sensitivity. Perform the analysis. At this time, the Raman analysis performing unit 120 detects the antigen with high sensitivity by fixing the aptamer of the above-described diagnostic reagent to the nanoparticles for the selective detection of the antigen.
  • the composite nanoparticles such as gold, silver nanoparticles, and gold (core) -silver (shell
  • the disease analyzer 130 determines the type of the disease corresponding to the antigen or the antigen. The disease analyzer 130 determines which disease is detected based on the aptamer-based diagnostic reagent used in the process of detecting the antigen through the Raman analysis performer 120.
  • the output unit 140 outputs and provides the detected type of disease to a user, and may include at least one of a display unit for providing by visual means or a speaker for providing by an audio means.
  • the communication unit 150 transmits and receives data with an external device or server of the diagnostic apparatus 1000, and communicates information about the type of disease detected along with personal information of the examinee, for example, a server of a hospital server or a diagnostic institution. It may be transmitted to, or transmitted to the doctor's portable terminal can be confirmed in the application installed on the portable terminal.
  • the memory 160 not only stores data and values generated by the diagnostic device 1000, but also stores various information such as programs, algorithms, and software used in the diagnostic device 1000.
  • the memory 160 may be implemented in hardware in the diagnostic device 1000 or in the form of an external cloud server.
  • the power supply unit 170 supplies power for the operation of the diagnostic device 1000.
  • the power supply unit 170 may receive external power through a wire, but when the diagnostic device 1000 is portable, it may be implemented in the form of a rechargeable battery.
  • the controller 180 controls the diagnostic device 1000 to operate according to its function and purpose by controlling an organic connection relationship between the components included in the diagnostic device 1000.
  • the diagnosis device 1000 may quickly analyze the infected acute recessive disease in the field, and even the non-expert may analyze the disease with high accuracy and sensitivity, thereby ensuring accessibility.
  • the diagnostic apparatus 1000 may be implemented in a form that is further miniaturized to be portable to further improve the field application.
  • FIG. 4 is a view for explaining a diagnostic reagent of the on-site diagnostic system according to the embodiment.
  • aptamer-based diagnostic reagents bind with high specificity and affinity with antigens, allowing direct detection of antigens without going through antibodies.
  • the nano probe 410 binds to the antigen 440 in the blood. Will be detected directly.
  • the proposed aptamer-based diagnostic reagent compared to indirectly detecting the presence of an antigen through detection of an antibody, the proposed aptamer-based diagnostic reagent enables direct detection of a target antigen without waiting for the production of the antibody. It produces a shrinking effect. Such rapidity enables accurate and rapid analysis and diagnosis of autumn disease in comparison with the prior art, so that a diagnosis system specialized for the field manifestation (POCT) can be implemented.
  • POCT field manifestation
  • FIG. 5 is a view for explaining a diagnostic kit of the on-site diagnostic system according to an embodiment.
  • 5 (a) depicts a diagnostic kit for antibody detection and
  • FIG. 5 (b) shows a diagnostic kit for antigen detection.
  • the diagnostic kit for antibody detection is divided into two parts so as to detect IgM antibody and IgG antibody at the same time, and the diagnostic kit for antigen detection is configured as a single unit.
  • the diagnostic kit seating part of the diagnostic device described above is configured to separately detect two different types of diagnostic kits.
  • the diagnostic kit seating part may include a part where the diagnostic kit for antibody detection is seated and a part where the diagnostic kit for antigen detection is seated separately, respectively, and two different diagnostic kits may be seated on one seating part. It may be.
  • FIG. 6 is a flowchart illustrating an on-site diagnosis method according to an exemplary embodiment. 6 illustrates the embodiments described with reference to FIGS. 2 through 5 according to a time series flow. Therefore, although the detailed description is omitted in FIG. 6, the above description may be applied to the same or similarly.
  • the diagnostic device of the on-site diagnostic system detects that the lateral flow diagnostic kit is disposed (S610).
  • the diagnostic kit disposed may be at least one of a diagnostic kit for detecting an antibody and a diagnostic kit for detecting an antigen.
  • the diagnostic device detects the Raman signal by reacting the blood injected into the diagnostic kit with the aptamer-based diagnostic reagent, and performs the Raman spectroscopy-based analysis according to the Raman signal (S620).
  • nanoparticles and surface-enhanced Raman scattering techniques can be used to amplify Raman signals.
  • the diagnostic device detects the antigen from the blood put in the diagnostic kit, and confirms the type of disease according to the antigen (S630). Alternatively, when the Raman signal is detected as a result of the Raman analysis, the diagnostic device may identify the type of disease based on the type of diagnostic reagent used for the detection of the antigen. The diagnosis device outputs the confirmed information when the type of the disease is identified, and provides the user with the type of disease in which the examinee is infected (S640).
  • the on-site diagnostic method described above can be written as a program that can be executed in a computer, it can be implemented in a general-purpose digital computer to operate the program using a computer readable medium.
  • the structure of the data used in the above-described method can be recorded on the computer-readable medium through various means.
  • a recording medium for recording an executable computer program or code for performing various methods of the present invention should not be understood to include temporary objects, such as carrier waves or signals.
  • the computer readable medium may include a storage medium such as a magnetic storage medium (eg, a ROM, a floppy disk, a hard disk, etc.), an optical reading medium (eg, a CD-ROM, a DVD, etc.).

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Abstract

L'invention concerne un système et un procédé de lieu d'intervention, le système comprenant : un réactif de diagnostic à base d'aptamères; un instrument de diagnostic permettant de détecter un signal Raman par l'intermédiaire d'une technique d'analyse Raman; et un kit de diagnostic à utiliser conformément à un procédé d'écoulement latéral, le sang et le réactif de diagnostic étant mis en réaction de façon à détecter un signal Raman lorsque le placement du kit de diagnostic est détecté, ce qui permet d'identifier le type de maladie fébrile aiguë.
PCT/KR2018/001369 2017-02-03 2018-02-01 Système de lieu d'intervention et procédé de diagnostic de maladie fébrile aiguë Ceased WO2018143684A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US16/483,195 US11366065B2 (en) 2017-02-03 2018-02-01 Point-of-care system and method for diagnosing acute febrile illness
CN201880022848.0A CN110546484A (zh) 2017-02-03 2018-02-01 用于诊断急性发热性疾病的现场即时系统和方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2017-0015390 2017-02-03
KR20170015390 2017-02-03
KR1020180012663A KR102047989B1 (ko) 2017-02-03 2018-02-01 급성 열성 질환을 진단하기 위한 현장 진단 시스템 및 방법
KR10-2018-0012663 2018-02-01

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20110019843A (ko) * 2009-08-21 2011-03-02 엘지이노텍 주식회사 면역진단키트의 검출시스템
KR20150104076A (ko) * 2015-08-28 2015-09-14 재단법인 아산사회복지재단 육안식별이 가능한 현장검사장치의 검사결과 관리 시스템 및 검사결과 관리 애플리케이션의 제어 방법
JP2016029400A (ja) * 2007-03-20 2016-03-03 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ 表面増強ラマン分光法（ｓｅｒｓ）活性粒子を使用するアッセイ
KR20160047890A (ko) * 2014-10-23 2016-05-03 주식회사 이뮨메드 의료용 진단 키트의 형광리더기
WO2016134214A1 (fr) * 2015-02-19 2016-08-25 Ionica Sciences Réactifs et procédés de détection de maladies infectieuses

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016029400A (ja) * 2007-03-20 2016-03-03 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ 表面増強ラマン分光法（ｓｅｒｓ）活性粒子を使用するアッセイ
KR20110019843A (ko) * 2009-08-21 2011-03-02 엘지이노텍 주식회사 면역진단키트의 검출시스템
KR20160047890A (ko) * 2014-10-23 2016-05-03 주식회사 이뮨메드 의료용 진단 키트의 형광리더기
WO2016134214A1 (fr) * 2015-02-19 2016-08-25 Ionica Sciences Réactifs et procédés de détection de maladies infectieuses
KR20150104076A (ko) * 2015-08-28 2015-09-14 재단법인 아산사회복지재단 육안식별이 가능한 현장검사장치의 검사결과 관리 시스템 및 검사결과 관리 애플리케이션의 제어 방법

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