WO2021221198A1 - Personal coronavirus antibody detecting kit set - Google Patents

Personal coronavirus antibody detecting kit set Download PDF

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Publication number
WO2021221198A1
WO2021221198A1 PCT/KR2020/005636 KR2020005636W WO2021221198A1 WO 2021221198 A1 WO2021221198 A1 WO 2021221198A1 KR 2020005636 W KR2020005636 W KR 2020005636W WO 2021221198 A1 WO2021221198 A1 WO 2021221198A1
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Prior art keywords
blood
disposable
personal
corona
user
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PCT/KR2020/005636
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French (fr)
Korean (ko)
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김형곤
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주식회사 메덱스
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Priority to PCT/KR2020/005636 priority Critical patent/WO2021221198A1/en
Publication of WO2021221198A1 publication Critical patent/WO2021221198A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses

Definitions

  • the present invention relates to a personal corona antibody diagnostic kit set, and more particularly, to a personal diagnostic kit set that can be carried and conveniently diagnosed by an individual.
  • Diagnosis of coronavirus is classified into molecular test and serology test.
  • the most commonly used diagnostic method is a molecular diagnostic method, which is performed by PCR or gene sequencing using a virus gene-specific primer from a nasal swap sample.
  • Serological diagnosis of coronavirus uses the principle of antigen-antibody reaction, and there are antibody diagnostic ELISA (enzyme-linked immunosorbent assay, enzyme-linked immunosorbent assay) for S antigen or NC antigen, or microneutralization assay.
  • the antibody diagnostic kit developed by Euroimmune (Germany) is used for diagnosing the coronavirus using the Indirect ELISA method based on the purified S1 antigen.
  • the antigen diagnostic kit is a method to check the presence or absence of N protein that COVID-19 self-replicates, and the test accuracy reaches 85%.
  • RT-PCR Real-Time Reverse Transcription Polymerase Chain Reaction
  • the antigen diagnostic kit can check the presence of infection in just 10 minutes through runny nose and sputum, and the antibody diagnostic kit through blood.
  • antibody diagnosis it is a test method based on serological changes, and since it targets blood, there is no inaccuracy in sample collection, and it has the advantage of low risk like the existing upper airway and lower respiratory tract samples.
  • Antibody test is a method to test the initial antibodies IgM and IgG produced in our body after virus infection in the blood. Antibody diagnosis has the advantage that anyone can do it without having to be an expert.
  • the conventional antibody diagnostic kit has a problem in that it is necessary to visit a hospital for blood collection. Although it takes only 10 minutes to diagnose the test, there is a problem in that the actual test takes a lot of time because it requires a visit to a hospital or a medical team to collect blood.
  • the present invention is to solve this problem, and it is an object of the present invention to provide a personal corona antibody diagnostic kit set that can be easily used by anyone by having a test cassette and a disposable blood collection device integrally.
  • the personal corona antibody diagnostic kit set includes a disposable blood collection device for collecting a user's blood, a disposable dropper for collecting the user's blood; a test cassette for diagnosing corona by analyzing the blood; a disposable reagent for facilitating analysis of blood in the test cassette; alcohol swab to disinfect the blood sampled area; And it is characterized in that the disposable latex gloves for the user to wear when collecting blood is integrally packaged.
  • the disposable blood collection device includes a case; a trigger that is inserted into the case and has a through hole through which a needle can pass, a slit of a long shape is symmetrically formed on the body, and a part protrudes toward the front of the case; a lancet comprising a percussion unit coupled to the needle and coupled to the slit, a spring supporting the percussion unit, and a rear cover supporting the spring and coupled to the rear end of the case; and a lid protecting the trigger, wherein when the trigger is pressed while the lid is removed, the lancet is triggered to collect blood.
  • the disposable reagent comprises deionized water, sodium chloride, and ethanol iodine.
  • a user can easily diagnose whether or not the Corona 19 virus is present without visiting a hospital or medical institution.
  • the present invention it is possible to diagnose whether or not the Corona-19 virus is present in a short time regardless of location, and even asymptomatic infection can be diagnosed in a short time, thereby preventing unnecessary isolation. Therefore, the time and cost required for isolation can be reduced.
  • FIG. 1 shows the configuration of a personal corona antibody diagnostic kit set according to the present invention.
  • FIG. 2 shows the detailed configuration of the disposable blood sampling machine.
  • FIG 3 shows the packaging box of the personal corona antibody diagnostic kit set according to the present invention.
  • first, second, A, and B may be used to describe various elements, but the elements should not be limited by the terms. The above terms are used only for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a second component, and similarly, a second component may also be referred to as a first component. and/or includes a combination of a plurality of related listed items or any of a plurality of related listed items.
  • Figure 1 shows a personal corona antibody diagnostic kit set according to the present invention.
  • Figure 1 (a) shows individual components
  • Figure 1 (b) shows a package including these components.
  • FIG. 2 is a detailed view of the blood sampling machine of FIG. 1
  • FIG. 3 is a view showing the packaging box together.
  • a personal corona antibody diagnostic kit set includes a disposable blood sampler 10 for collecting a user's blood, a disposable eyedropper 20 for collecting the user's blood, and a test cassette for diagnosing corona by analyzing the blood. (30), a disposable reagent 40 for facilitating the analysis when the blood of the test cassette is analyzed, and a disposable alcohol swab 50 for sterilizing the blood sample may be integrally packaged.
  • disposable latex gloves 60 for preventing contamination during blood collection may be further added.
  • the disposable blood collection device 10 is a personal blood collection device that can simply collect blood without going to a hospital.
  • the blood collection device 10 includes a case 11 , a trigger 12 , a lancet 13 , a rear cover 14 , and a lid 15 .
  • the trigger 12 is inserted into the case 11 so that a through hole 121 through which a needle can pass is formed, and a slit 122 having an elongated shape is symmetrically formed on the body. A part of the body protrudes toward the front of the case and serves as an operation switch.
  • the lancet 13 includes a percussion part 131 to which a needle is coupled and coupled to the slit, and a spring 132 for supporting the percussion part.
  • the rear cover 14 serves to block the rear of the case and support the spring 132 .
  • the lid 15 is coupled to the front of the case to protect the trigger. It is possible to prevent the protruding trigger from arbitrarily triggering, and it is possible to prevent an accident of being stabbed by a needle.
  • the disposable dropper 20 is for collecting blood collected by a blood collection device. When the disposable dropper 20 is in contact with the blood on the finger, the blood is sucked into the disposable dropper by the pressure difference.
  • the test cassette 30 is a test kit for diagnosing blood, and a general antibody diagnostic cassette sold in the market may be used.
  • the test cassettes are striped in either the M or G regions in response to IgM and IgG antibodies. If the IgM antibody is positive, a stripe is formed in the M region, and if the IgG antibody is positive, a stripe is formed in the G region. Therefore, if both IgM and IgG antibodies are positive, both stripes may be formed.
  • the disposable reagent 40 is for facilitating the antibody diagnosis of the test cassette 30, and a mixed solution composed of deionized water, sodium chloride, and ethanol iodine may be used.
  • deionized water may include 96.55 wt%, sodium chloride 0.85 wt%, and ethanol iodine (Nonylphenoxypoly(ethylenoxy) ethanol) 2.5 wt%.
  • ethanol iodine Nonylphenoxypoly(ethylenoxy) ethanol
  • 0.1% by weight of Kathon 886 may be included.
  • the disposable alcohol swab 50 is to prevent contamination, and is used to disinfect the site to be collected before blood collection.
  • the disposable latex gloves may be provided to prevent infection.
  • the disposable blood sampler, disposable dropper, test cassette, disposable reagent, disposable alcohol swab, and disposable latex gloves are provided as a set and packaged in one box. Corona infection can be easily diagnosed regardless of location.
  • a user may use a disposable alcohol swab to disinfect a blood collection site, and then use a disposable blood collection device to prick a desired area, such as a finger, to collect blood.
  • a disposable blood collection device When blood is collected on the finger by the blood collection device, it is collected using a disposable dropper and dropped into a test cassette.
  • the present invention since a user can easily diagnose whether or not a corona infection is present anywhere, it is possible to easily check for corona infection even at an airport without a separate quarantine measure.
  • the present invention can be applied to the field of COVID-19 virus diagnosis.

Abstract

A personal coronavirus antibody detecting kit set according to the present invention is characterized in that a disposable blood collector for collecting the blood of a user, a disposable pipette for collecting the blood of the user, a test cassette for detecting coronavirus by analyzing the blood, a single-use reagent for promoting analysis when analyzing the blood in the test cassette; an alcohol swab for sterilizing the blood collection site, and disposable latex gloves to be worn by the user during blood collection are integrally packaged.

Description

개인용 코로나 항체 진단 키트 세트Personal Corona Antibody Diagnostic Kit Set
본 발명은 개인용 코로나 항체 진단 키트 세트에 관한 것으로, 보다 구체적으로 개인이 휴대하면서 간편하게 코로나 바이러스를 진단할 수 있는 개인용 진단 키트 세트에 관한 것이다. The present invention relates to a personal corona antibody diagnostic kit set, and more particularly, to a personal diagnostic kit set that can be carried and conveniently diagnosed by an individual.
코로나 바이러스의 진단은 분자적 진단(Molecular Test)과 혈청학적 진단(Serology Test)으로 분류된다. 가장 흔히 사용하는 진단법은 분자적 진단법으로, 콧물(nasal swap) 검체로부터의 바이러스 유전자 특이적 프라이머(primer)를 이용한 PCR이나 유전자 염기 서열 분석에 의한 것이다. 코로나 바이러스의 혈청학적 진단법은 항원-항체 반응의 원리를 이용한 것으로, S 항원 또는 NC 항원에 대한 항체 진단 ELISA(enzyme-linked immunosorbent assay, 효소결합면역측정법), 또는 microneutralization 분석법 등이 있다. Euroimmune사(독일)에서 개발된 항체 진단 키트는, 정제된 S1 항원에 기초한 Indirect ELISA 방법을 이용하여 코로나 바이러스를 진단하는 용도로 사용되고 있다. Diagnosis of coronavirus is classified into molecular test and serology test. The most commonly used diagnostic method is a molecular diagnostic method, which is performed by PCR or gene sequencing using a virus gene-specific primer from a nasal swap sample. Serological diagnosis of coronavirus uses the principle of antigen-antibody reaction, and there are antibody diagnostic ELISA (enzyme-linked immunosorbent assay, enzyme-linked immunosorbent assay) for S antigen or NC antigen, or microneutralization assay. The antibody diagnostic kit developed by Euroimmune (Germany) is used for diagnosing the coronavirus using the Indirect ELISA method based on the purified S1 antigen.
항원 진단키트는 코로나19가 자가 복제하는 N단백질 유무를 확인하는 방식으로, 검사 정확도는 85%에 달한다. 정부에서 시행하는 유전자 검사 RT-PCR(실시간 역전사 중합효소연쇄반응) 대비 정확도가 다소 떨어지지만, RT-PCR은 검체운반 이동·검사 사전준비 시간 등을 포함해 결과를 6시간이나 기다려야 하는 치명적인 단점이 있었다. The antigen diagnostic kit is a method to check the presence or absence of N protein that COVID-19 self-replicates, and the test accuracy reaches 85%. Although the accuracy of the RT-PCR (Real-Time Reverse Transcription Polymerase Chain Reaction) gene test conducted by the government is somewhat lower, RT-PCR has a fatal disadvantage in that it has to wait for 6 hours, including the time for specimen transport and test preparation time. there was.
항원 진단키트는 콧물·가래, 항체 진단키트는 혈액을 통해 단 10분 만에 감염여부를 확인할 수 있다. The antigen diagnostic kit can check the presence of infection in just 10 minutes through runny nose and sputum, and the antibody diagnostic kit through blood.
항체진단의 경우 혈청학적 변화를 근거로 하는 검사법으로 혈액을 대상으로 하므로 검체 채취의 부정확성도 없으며 기존의 상기도 하기도 검체채취처럼 위험도도 낮다는 장점이 있다. 항체 검사는 바이러스 감염 후 우리몸에서 만들어지는 초기 항체 IgM, IgG를 혈액에서 검사하는 방법이다. 항체 진단은 전문가가 아니어도 누구나 할 수 있다는 장점이 있다. In the case of antibody diagnosis, it is a test method based on serological changes, and since it targets blood, there is no inaccuracy in sample collection, and it has the advantage of low risk like the existing upper airway and lower respiratory tract samples. Antibody test is a method to test the initial antibodies IgM and IgG produced in our body after virus infection in the blood. Antibody diagnosis has the advantage that anyone can do it without having to be an expert.
하지만, 종래의 항체 진단 키트는 혈액 채취를 위해서 병원을 방문해야 하는 문제점이 있다. 검사 진단에 소요되는 시간은 10분에 불과하지만 병원을 방문하거나 의료진이 혈액을 채취해야 하기 때문에 실제 검사에는 많은 시간이 소요된다는 문제점이 있다. However, the conventional antibody diagnostic kit has a problem in that it is necessary to visit a hospital for blood collection. Although it takes only 10 minutes to diagnose the test, there is a problem in that the actual test takes a lot of time because it requires a visit to a hospital or a medical team to collect blood.
본 발명은 이러한 문제점을 해결하기 위한 것으로, 테스트 카세트와 일회용 채혈기를 일체로 구비하여 누구나 손쉽게 사용할 수 있는 개인용 코로나 항체 진단 키트 세트를 제공하고자 한다. The present invention is to solve this problem, and it is an object of the present invention to provide a personal corona antibody diagnostic kit set that can be easily used by anyone by having a test cassette and a disposable blood collection device integrally.
본 발명에 개인용 코로나 항체 진단 키트 세트는, 사용자의 혈액을 채취하는 일회용 채혈기, 상기 사용자의 혈액을 수거하기 위한 일회용 스포이드; 상기 혈액을 분석하여 코로나 여부를 진단하는 테스트 카세트; 상기 테스트 카세트의 혈액을 분석시 분석을 촉진하도록 하는 일회용 시약; 채혈된 부분을 소독하기 위한 알코올 솜; 및 사용자가 채혈시 착용하기 위한 일회용 라텍스 장갑이 일체로 포장되어 있는 것을 특징으로 한다.The personal corona antibody diagnostic kit set according to the present invention includes a disposable blood collection device for collecting a user's blood, a disposable dropper for collecting the user's blood; a test cassette for diagnosing corona by analyzing the blood; a disposable reagent for facilitating analysis of blood in the test cassette; alcohol swab to disinfect the blood sampled area; And it is characterized in that the disposable latex gloves for the user to wear when collecting blood is integrally packaged.
본 발명의 실시예에서, 상기 일회용 채혈기는 케이스; 상기 케이스에 삽입되어 바늘이 관통할 수 있는 관통공이 형성되고, 몸체에는 기다란 형상의 슬릿이 대칭되어 형성되고, 케이스 전방으로 일부가 돌출되어 있는 트리거; 바늘이 결합되어 상기 슬릿에 결합되는 격발부, 상기 격발부를 지지하는 스프링, 및 상기 스프링을 지지하고 상기 케이스의 후단에 결합되어 후방 덮게를 포함하는 란셋; 및 상기 트리거를 보호하는 뚜껑을 포함하고, 뚜껑이 제거된 상태에서 상기 트리거가 눌려지면 란셋이 격발되어 채혈하는 것을 특징으로 한다. In an embodiment of the present invention, the disposable blood collection device includes a case; a trigger that is inserted into the case and has a through hole through which a needle can pass, a slit of a long shape is symmetrically formed on the body, and a part protrudes toward the front of the case; a lancet comprising a percussion unit coupled to the needle and coupled to the slit, a spring supporting the percussion unit, and a rear cover supporting the spring and coupled to the rear end of the case; and a lid protecting the trigger, wherein when the trigger is pressed while the lid is removed, the lancet is triggered to collect blood.
본 발명의 실시예에서, 상기 일회용 시약은 탈이온수, 소듐 클로라이드, 에탄올요오드를 포함하는 것을 특징으로 한다.In an embodiment of the present invention, the disposable reagent comprises deionized water, sodium chloride, and ethanol iodine.
본 발명에 의하면, 사용자는 병원이나 의료기관에 방문하지 않고도 손쉽게 코로나-19 바이러스 여부를 진단할 수 있다. According to the present invention, a user can easily diagnose whether or not the Corona 19 virus is present without visiting a hospital or medical institution.
또한, 본 발명에 의하면 장소에 구애받지 않고 빠른 시간내에 코로나-19 바이러스 여부를 진단할 수 있고, 무증상 감염까지도 빠른 시간 안에 진단할 수 있어 불필요한 격리를 막을 수 있다. 따라서 격리에 소요되는 시간과 비용을 절감할 수 있다.In addition, according to the present invention, it is possible to diagnose whether or not the Corona-19 virus is present in a short time regardless of location, and even asymptomatic infection can be diagnosed in a short time, thereby preventing unnecessary isolation. Therefore, the time and cost required for isolation can be reduced.
도 1은 본 발명에 따른 개인용 코로나 항체 진단 키트 세트의 구성을 나타낸 것이다. 1 shows the configuration of a personal corona antibody diagnostic kit set according to the present invention.
도 2는 일회용 채혈기의 상세 구성을 나타낸 것이다. Figure 2 shows the detailed configuration of the disposable blood sampling machine.
도 3은 본 발명에 따른 개인용 코로나 항체 진단 키트 세트의 포장 박스를 함께 나타낸 것이다. 3 shows the packaging box of the personal corona antibody diagnostic kit set according to the present invention.
본 발명은 다양한 변경을 가할 수 있고 여러 가지 실시예를 가질 수 있는 바, 특정 실시예들을 도면에 예시하고 상세한 설명에 상세하게 설명하고자 한다. 그러나, 이는 본 발명을 특정한 실시 형태에 대해 한정하려는 것이 아니며, 본 발명의 사상 및 기술 범위에 포함되는 모든 변경, 균등물 내지 대체물을 포함하는 것으로 이해되어야 한다. 본 발명을 설명함에 있어서 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 흐릴 수 있다고 판단되는 경우 그 상세한 설명을 생략한다.Since the present invention can have various changes and can have various embodiments, specific embodiments are illustrated in the drawings and described in detail in the detailed description. However, this is not intended to limit the present invention to specific embodiments, and it should be understood to include all modifications, equivalents and substitutes included in the spirit and scope of the present invention. In describing the present invention, if it is determined that a detailed description of a related known technology may obscure the gist of the present invention, the detailed description thereof will be omitted.
제1, 제2, A, B 등의 용어는 다양한 구성요소들을 설명하는데 사용될 수 있지만, 상기 구성요소들은 상기 용어들에 의해 한정되어서는 안 된다. 상기 용어들은 하나의 구성요소를 다른 구성요소로부터 구별하는 목적으로만 사용된다. 예를 들어, 본 발명의 권리 범위를 벗어나지 않으면서 제1 구성요소는 제2 구성요소로 명명될 수 있고, 유사하게 제2 구성요소도 제1 구성요소로 명명될 수 있다. 및/또는 이라는 용어는 복수의 관련된 기재된 항목들의 조합 또는 복수의 관련된 기재된 항목들 중의 어느 항목을 포함한다.Terms such as first, second, A, and B may be used to describe various elements, but the elements should not be limited by the terms. The above terms are used only for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, a first component may be referred to as a second component, and similarly, a second component may also be referred to as a first component. and/or includes a combination of a plurality of related listed items or any of a plurality of related listed items.
본 출원에서 사용한 용어는 단지 특정한 실시예를 설명하기 위해 사용된 것으로, 본 발명을 한정하려는 의도가 아니다. 단수의 표현은 문맥상 명백하게 다르게 뜻하지 않는 한, 복수의 표현을 포함한다. 본 출원에서, "포함하다" 또는 "가지다" 등의 용어는 명세서상에 기재된 특징, 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것이 존재함을 지정하려는 것이지, 하나 또는 그 이상의 다른 특징들이나 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것들의 존재 또는 부가 가능성을 미리 배제하지 않는 것으로 이해되어야 한다.The terms used in the present application are only used to describe specific embodiments, and are not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly dictates otherwise. In the present application, terms such as “comprise” or “have” are intended to designate that a feature, number, step, operation, component, part, or combination thereof described in the specification exists, but one or more other features It should be understood that this does not preclude the existence or addition of numbers, steps, operations, components, parts, or combinations thereof.
이하 첨부된 도면을 참조하여 본 발명의 구성을 상세히 살펴보기로 한다. Hereinafter, the configuration of the present invention will be described in detail with reference to the accompanying drawings.
도 1은 본 발명에 따른 개인용 코로나 항체 진단 키트 세트를 나타낸 것으로 도 1의 (a)는 개별 구성을 나타낸 것이고, 도 1의 (b)는 이들 구성을 포함하는 포장을 나타낸 것이다. 도 2는 도 1의 채혈기의 상세도를 나타낸 것이이고, 도 3은 포장 박스를 함께 나타낸 것이다. Figure 1 shows a personal corona antibody diagnostic kit set according to the present invention. Figure 1 (a) shows individual components, and Figure 1 (b) shows a package including these components. FIG. 2 is a detailed view of the blood sampling machine of FIG. 1 , and FIG. 3 is a view showing the packaging box together.
본 발명에 따른 하는 개인용 코로나 항체 진단 키트 세트는 사용자의 혈액을 채취하는 일회용 채혈기(10), 상기 사용자의 혈액을 수거하기 위한 일회용 스포이드(20), 상기 혈액을 분석하여 코로나 여부를 진단하는 테스트 카세트(30), 상기 테스트 카세트의 혈액을 분석시 분석을 촉진하도록 하는 일회용 시약(40), 및 채혈된 부분을 소독하기 위한 일회용 알코올 솜(50)이 일체로 포장될 수 있다. A personal corona antibody diagnostic kit set according to the present invention includes a disposable blood sampler 10 for collecting a user's blood, a disposable eyedropper 20 for collecting the user's blood, and a test cassette for diagnosing corona by analyzing the blood. (30), a disposable reagent 40 for facilitating the analysis when the blood of the test cassette is analyzed, and a disposable alcohol swab 50 for sterilizing the blood sample may be integrally packaged.
그리고 채혈시 오염을 방지하기 위한 일회용 라텍스 장갑(60)이 더 추가될 수 있다. And disposable latex gloves 60 for preventing contamination during blood collection may be further added.
상기 일회용 채혈기(10)는 개인용 채혈기로 병원에 가지 않고도 간단하게 채혈할 수 있는 구조이다. The disposable blood collection device 10 is a personal blood collection device that can simply collect blood without going to a hospital.
도 2를 참조하면, 상기 채혈기(10)는 케이스(11), 트리거(12), 란셋(13), 후방덮개(14), 및 뚜겅(15)을 포함한다.Referring to FIG. 2 , the blood collection device 10 includes a case 11 , a trigger 12 , a lancet 13 , a rear cover 14 , and a lid 15 .
상기 트리거(12)는 케이스(11)에 삽입되어 바늘이 관통할 수 있는 관통공(121)이 형성되고, 몸체에는 기다란 형상의 슬릿(122)이 대칭되어 형성되다. 몸체의 일부는 케이스 전방으로 돌출되어 작동 스위치 역할을 한다. The trigger 12 is inserted into the case 11 so that a through hole 121 through which a needle can pass is formed, and a slit 122 having an elongated shape is symmetrically formed on the body. A part of the body protrudes toward the front of the case and serves as an operation switch.
상기 란셋(13)은 바늘이 결합되어 상기 슬릿에 결합되는 격발부(131) 및 상기 격발부를 지지하는 스프링(132)을 포함한다. The lancet 13 includes a percussion part 131 to which a needle is coupled and coupled to the slit, and a spring 132 for supporting the percussion part.
상기 후방 덮개(14)는 케이스의 후방을 막고 상기 스프링(132)을 지지하는 기능을 한다.The rear cover 14 serves to block the rear of the case and support the spring 132 .
상기 뚜껑(15)은 케이스 전방에 결합되어 트리거를 보호한다. 돌출된 트리거가 임의로 격발시키는 것을 방지하고, 바늘에 찔리는 사고를 방지할 수 있다. The lid 15 is coupled to the front of the case to protect the trigger. It is possible to prevent the protruding trigger from arbitrarily triggering, and it is possible to prevent an accident of being stabbed by a needle.
상기 일회용 스포이드(20)는 채혈기에 의해 채혈된 혈액을 수거하기 위한 것이다. 손가락 상의 혈액에 일회용 스포이드(20)를 접촉하면 혈액은 압력차에 이해 일회용 스포이드 안으로 빨려들어가게 된다. The disposable dropper 20 is for collecting blood collected by a blood collection device. When the disposable dropper 20 is in contact with the blood on the finger, the blood is sucked into the disposable dropper by the pressure difference.
상기 테스트 카세트(30)는 혈액을 진단하는 테스트 키트로 시중에서 판매되고 있는 일반적인 항체 진단 카세트가 사용될 수 있다. 상기 테스트 카세트는 IgM 및 IgG 항체에 반응하여 M 또는 G 부분에 스트라이프가 생긴다. IgM 항체 양성이면 M 부분에 줄이 생기고 IgG 항체 양성이면 G 부분에 스트라이프가 생긴다. 따라서 IgM, IgG 항체 모두 양성이면 양쪽 다 스트라이프가 생길 수 있다. The test cassette 30 is a test kit for diagnosing blood, and a general antibody diagnostic cassette sold in the market may be used. The test cassettes are striped in either the M or G regions in response to IgM and IgG antibodies. If the IgM antibody is positive, a stripe is formed in the M region, and if the IgG antibody is positive, a stripe is formed in the G region. Therefore, if both IgM and IgG antibodies are positive, both stripes may be formed.
상기 일회용 시약(40)은 상기 테스트 카세트(30)의 항체 진단을 촉진하기 위한 것으로, 탈이온수, 소듐 클로라이드, 및 에탄올요오드로 구성된 혼합액이 사용될 수 있다. 구체적으로 탈이온수(Deionized Water)는 96.55중량%, 소듐 클로라이드(Sodium chloride)는 0.85 중량%, 에탄올요오드(Nonylphenoxypoly(ethylenoxy) ethanol)는 2.5 중량%를 포함할 수 있다. 이외에 Kathon 886 0.1중량%를 포함할 수 있다. The disposable reagent 40 is for facilitating the antibody diagnosis of the test cassette 30, and a mixed solution composed of deionized water, sodium chloride, and ethanol iodine may be used. Specifically, deionized water may include 96.55 wt%, sodium chloride 0.85 wt%, and ethanol iodine (Nonylphenoxypoly(ethylenoxy) ethanol) 2.5 wt%. In addition, 0.1% by weight of Kathon 886 may be included.
상기 일회용 알코올 솜(50)은 오염을 방지하기 위한 것으로, 채혈전 채혈될 부위를 소독하기 위해 사용된다. The disposable alcohol swab 50 is to prevent contamination, and is used to disinfect the site to be collected before blood collection.
상기 일회용 라텍스 장갑은 감염 방지를 위해 구비될 수 있다. The disposable latex gloves may be provided to prevent infection.
상기와 같이 일회용 채혈기, 일회용 스포이드, 테스트 카세트, 일회용 시약, 일회용 알코올 솜, 일회용 라텍스 장갑이 세트로 구비되어 하나의 박스에 포장되어 있으므로 사용자는 개인용 코로나 항체 진단 키트 세트를 구입함으로써 병원이나 의료기관 방문없이 장소에 구애받지 않고 손쉽게 코로나 감염 여부를 진단할 수 있다. As described above, the disposable blood sampler, disposable dropper, test cassette, disposable reagent, disposable alcohol swab, and disposable latex gloves are provided as a set and packaged in one box. Corona infection can be easily diagnosed regardless of location.
상기 진단 키트 세트를 이용한 검진 방법을 간략히 살펴보면 아래와 같다. The examination method using the diagnostic kit set will be briefly described as follows.
먼저, 사용자는 일회용 알코올 솜을 이용하여 채혈 부위를 소독한 후, 일회용 채혈기를 이용하여 손가락 등 채혈하고자 하는 부위를 찔러 채혈할 수 있다. 채혈기에 의해 혈액이 손가락에 맺히면 일회용 스포이드를 이용하여 이를 수거하여 테스트 카세트에 떨어트린다. First, a user may use a disposable alcohol swab to disinfect a blood collection site, and then use a disposable blood collection device to prick a desired area, such as a finger, to collect blood. When blood is collected on the finger by the blood collection device, it is collected using a disposable dropper and dropped into a test cassette.
혈액을 떨어트린 후 일회용 시약을 일정량 떨어트린 후 10분 정도 경과하면 코로나-19 바이러스 감염 여부를 확인할 수 있다. After dropping a certain amount of disposable reagent after dropping blood, it is possible to check whether or not the corona-19 virus is infected after about 10 minutes have elapsed.
본 발명에 따르면 사용자는 어디서든지 쉽게 코로나 감염 여부를 진단할 수 있으므로, 공항에서도 별도의 격리 조치 없이 손쉽게 코로나 여부를 검진할 수 있다. According to the present invention, since a user can easily diagnose whether or not a corona infection is present anywhere, it is possible to easily check for corona infection even at an airport without a separate quarantine measure.
따라서 격리에 발생되는 시간과 비용의 손실을 방지할 수 있다. Therefore, it is possible to prevent the loss of time and money caused by isolation.
이상에서 실시예를 중심으로 설명하였으나 이는 단지 예시일 뿐 본 발명을 한정하는 것이 아니며, 본 발명이 속하는 분야의 통상의 지식을 가진 자라면 본 실시예의 본질적인 특성을 벗어나지 않는 범위에서 이상에 예시되지 않은 여러 가지의 변형과 응용이 가능함을 알 수 있을 것이다. 예를 들어, 실시예에 구체적으로 나타난 각 구성 요소는 변형하여 실시할 수 있는 것이다. 그리고 이러한 변형과 응용에 관계된 차이점들은 첨부된 청구 범위에서 규정하는 본 발명의 범위에 포함되는 것으로 해석되어야 할 것이다.Although the embodiment has been described above, it is only an example and does not limit the present invention, and those of ordinary skill in the art to which the present invention pertains are not exemplified above in a range that does not depart from the essential characteristics of the present embodiment. It will be appreciated that various modifications and applications are possible. For example, each component specifically shown in the embodiment can be implemented by modification. And differences related to such modifications and applications should be construed as being included in the scope of the present invention defined in the appended claims.
본 발명은 코로나-19 바이러스 진단 분야에 적용될 수 있다. The present invention can be applied to the field of COVID-19 virus diagnosis.

Claims (3)

  1. 사용자의 혈액을 채취하는 채혈기, a blood sampler that collects the user's blood;
    상기 사용자의 혈액을 수거하기 위한 일회용 스포이드;a disposable dropper for collecting the user's blood;
    상기 혈액을 분석하여 코로나 여부를 진단하는 테스트 카세트;a test cassette for diagnosing corona by analyzing the blood;
    상기 테스트 카세트의 혈액을 분석시 분석을 촉진하도록 하는 일회용 시약; a disposable reagent for facilitating analysis of blood in the test cassette;
    채혈된 부분을 소독하기 위한 알코올 솜; 및alcohol swab to disinfect the blood sampled area; and
    사용자가 채혈시 착용하기 위한 일회용 라텍스 장갑이 일체로 포장되어 있는 것을 특징으로 하는 개인용 코로나 항체 진단 키트 세트. A personal corona antibody diagnostic kit set, characterized in that disposable latex gloves to be worn by the user when collecting blood are packaged in one piece.
  2. 제1항에 있어서, 상기 채혈기는 The method of claim 1, wherein the blood collection device
    케이스, case,
    상기 케이스에 삽입되어 바늘이 관통할 수 있는 관통공이 형성되고, 몸체에는 기다란 형상의 슬릿이 대칭되어 형성되고, 케이스 전방으로 일부가 돌출되어 있는 트리거;a trigger that is inserted into the case and has a through hole through which a needle can pass, a slit of a long shape is symmetrically formed on the body, and a part protrudes toward the front of the case;
    바늘이 결합되어 상기 슬릿에 결합되는 격발부, 상기 격발부를 지지하는 스프링, 및 상기 스프링을 지지하고 상기 케이스의 후단에 결합되어 후방 덮게를 포함하는 란셋;a lancet comprising a percussion unit coupled to the needle and coupled to the slit, a spring supporting the percussion unit, and a rear cover supporting the spring and coupled to the rear end of the case;
    상기 트리거를 보호하는 뚜껑을 포함하고, a lid protecting the trigger;
    뚜껑이 제거된 상태에서 상기 트리거가 눌려지면 란셋이 격발되어 채혈하는 것을 특징으로 하는 개인용 코로나 항체 진단 키트 세트. A personal corona antibody diagnostic kit set, characterized in that when the trigger is pressed while the lid is removed, the lancet is triggered to collect blood.
  3. 제1항에 있어서, According to claim 1,
    상기 일회용 시약은 탈이온수, 소듐 클로라이드, 에탄올요오드를 포함하는 것을 특징으로 하는 개인용 코로나 항체 진단 키트 세트. The disposable reagent is a personal corona antibody diagnostic kit set, characterized in that it comprises deionized water, sodium chloride, ethanol iodine.
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WO2023077483A1 (en) * 2021-11-06 2023-05-11 江汉大学 Mnp marker combination of human coronavirus hcov-hku1, primer pair combination, kit and uses thereof

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