KR102500714B1 - Composition for diagnosis of sars-cov-2 infection and diagnostic kit using thereof - Google Patents
Composition for diagnosis of sars-cov-2 infection and diagnostic kit using thereof Download PDFInfo
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
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- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
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- 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
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
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Abstract
Description
본 발명은 검체 채취가 용이한 효과를 갖는 코로나 바이러스 감염 진단을 위한 검체 채취용 조성물 및 이를 이용한 코로나 바이러스 감염 진단 키트에 관한 것이다.The present invention relates to a sample collection composition for diagnosing corona virus infection having an effect of easy sample collection and a coronavirus infection diagnosis kit using the same.
코로나19(COVID-19, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2))는 외피가 있는 양성가닥 RNA 바이러스(non-segmented positive-strand RNA virus)로서 전염성이 높고 병원성인 것으로 보고되어 감염된 환자에게 심각한 폐렴 증상을 유발한다. COVID-19 (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)) is an enveloped, non-segmented positive-strand RNA virus that has been reported to be highly contagious and pathogenic to infected patients. cause severe pneumonia.
계통 분석 결과 SARS-관련 코로나바이러스와 가장 가까운 것으로 확인되었다. 코로나19의 명칭은 감염병을 나타내는 것으로, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)는 바이러스 이름을 나타내는 것으로 각각 분리되어 명명되었다.Phylogenetic analysis identified it as closest to SARS-associated coronaviruses. The name of Corona 19 represents an infectious disease, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) represents the name of the virus, respectively.
코로나19는 감염자의 비말이 호흡기나 눈, 코, 입의 점막으로 침투될 때 전염되는 것으로 알려져 있으며, 특히, 노인 및/또는 심혈관 질환, 당뇨병, 만성 호흡기 질환 및 암과 같은 기저 질환을 가진 사람들에게 생명을 위협할 수 있는 것으로 알려져 있다.COVID-19 is known to be transmitted when droplets from an infected person penetrate the respiratory tract or mucous membranes of the eyes, nose, or mouth, especially in the elderly and/or those with underlying diseases such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer. It is known to be life threatening.
더욱이, 최근 다양한 변이가 속출하며, 감염 속도와 확산 범위 측면에서 기존의 다른 코로나 바이러스과 대비하여 특이점을 가진다. 이는 다른 코로나 바이러스에 비해 잠복기가 14일로 긴 편이어서, 감염되었으나 무증상인 상태에서 다른 사람에게 감염원을 옮길 수 있는 가능성이 높기 때문이다.Moreover, various mutations have recently appeared one after another, and it has a peculiarity compared to other existing coronaviruses in terms of infection rate and spread range. This is because it has a longer incubation period of 14 days than other coronaviruses, so there is a high possibility that it can spread the source of infection to others while being infected but asymptomatic.
SARS-CoV-2는 5 가지 주요 단백질 영역으로서 ORF1ab(replicase complex), 스파이크, 인벨로프, 막 및 뉴클레오캡시드 단백질을 가지고 있다. SARS-CoV-2의 감염 진단을 위한 방법으로는, PCR 검사, 신속 항원 검사 등이 있으며, 간편하고, 대량 검사가 가능하며, 비교적 즉각적인 감염 여부를 확인할 수 있는 신속 항원 검사가 널리 활용되고 있다.SARS-CoV-2 has five major protein regions: ORF1ab (replicase complex), spike, envelope, membrane and nucleocapsid proteins. As methods for diagnosing SARS-CoV-2 infection, there are PCR tests, rapid antigen tests, etc., and rapid antigen tests are widely used because they are simple, mass-testable, and can confirm relatively immediate infection.
신속 항원 검사는 대상의 콧구멍을 통해 검체 채취 면봉으로 비인두에서 분비물을 긁어 검체를 채취함에 따라, 검체의 채취 과정에서 대상(검사 대상자)으로 하여금 불쾌감과 통증을 유발하는 문제가 있어, 신속한 검사법임에도 불구하고, 꺼려지는 검사방법의 하나로 인식되고 있다.The rapid antigen test collects a sample by scraping secretions from the nasopharynx with a sample collection swab through the nostrils of the subject, causing discomfort and pain to the subject (test subject) during the sample collection process. Despite this, it is recognized as one of the reluctant inspection methods.
비인두에서 검체의 채취 시 분비물을 긁어낼 필요 없이, 가볍게 접촉하는 것만으로 검체를 채취할 수 있도록 하여 검사를 보다 원활히 수행할 수 있는 기술에 대한 개발이 필요한 실정이다.When collecting a sample from the nasopharynx, there is a need to develop a technology that can more smoothly perform the test by allowing the sample to be collected only by lightly touching it without the need to scrape secretions.
비인두에 가볍게 접촉하여도 코로나 바이러스 진단을 위한 검체의 채취가 가능하여 검체 채취 시의 불쾌감과 불편함을 완화시킬 수 있는 코로나 바이러스 감염 진단을 위한 검체 채취용 조성물을 제공하는 것을 목적으로 한다.It is an object of the present invention to provide a composition for collecting samples for diagnosing coronavirus infection that can relieve discomfort and discomfort during sample collection by allowing samples to be collected for diagnosis of coronavirus even when lightly contacted with the nasopharynx.
본 발명은 또한, 검체의 고정력이 우수한 한편, 추출 버퍼에 넣으면 코로나 바이러스의 추출이 용이하여, 민감도와 특이도가 우수한 효과를 갖는 코로나 바이러스 감염 진단 키트를 제공하는 것을 목적으로 한다.Another object of the present invention is to provide a diagnostic kit for corona virus infection, which has excellent fixation power of a sample, easy extraction of coronavirus when put in an extraction buffer, and excellent sensitivity and specificity.
상기와 같은 과제를 해결하기 위한, 본 발명에 따른 검체 채취용 조성물은, 검사 대상자의 비인두로부터 검체를 채취하는 검체 채취 면봉 검체로부터 코로나바이러스를 추출하기 위한 추출 버퍼가 담긴 추출용 용기 상기 추출 버퍼에 상기 검체 채취 면봉을 침지시켜 얻어진 검출액을 적가하는 검출액 투입부와 코로나 바이러스의 감염 여부를 시각적으로 나타내는 식별부를 구비한 진단 본체를 포함하는, 코로나 바이러스(SARS-CoV-2) 감염 진단 키트에 사용되는 검체 채취용 조성물로서, 생리 식염수 100 중량부, 폴리메틸메타크릴레이트(Polymethylmethacrylate, PMMA) 20 내지 30 중량부, 히알루론산 10 내지 15 중량부 및 펙틴 5 내지 7 중량부를 포함하는 코로나 바이러스 감염 진단 키트에 사용되는 검체 채취용 조성물에 관한 것이다.In order to solve the above problems, the composition for sampling according to the present invention is an extraction container containing an extraction buffer for extracting coronavirus from a specimen collection swab specimen that collects a specimen from the nasopharynx of a test subject. The extraction buffer A coronavirus (SARS-CoV-2) infection diagnosis kit comprising a diagnosis main body having a detection liquid injection unit for dropwise addition of a detection liquid obtained by immersing the sample collection swab in and an identification unit that visually indicates whether or not coronavirus is infected. As a sample collection composition used for corona virus infection, including 100 parts by weight of physiological saline, 20 to 30 parts by weight of polymethylmethacrylate (PMMA), 10 to 15 parts by weight of hyaluronic acid, and 5 to 7 parts by weight of pectin It relates to a composition for sampling used in a diagnostic kit.
본 발명에 있어서, 상기 생리 식염수는 의료기기에 사용될 수 있는 것을 사용하는 것이 바람직하고, 이에 관해서는, 관련 기술분야의 기술을 참고할 수 있다.In the present invention, it is preferable to use the physiological saline solution that can be used in medical devices, and in this regard, reference may be made to techniques in the related art.
상기 폴리메틸메타크릴레이트는 분말 형태로 계량되어 첨가되며, 상기 생리 식염수 100 중량부를 기준으로 20 내지 30 중량부, 보다 바람직하게는, 22 내지 25 중량부로 첨가될 수 있다.The polymethylmethacrylate is metered and added in powder form, and may be added in an amount of 20 to 30 parts by weight, more preferably 22 to 25 parts by weight, based on 100 parts by weight of the physiological saline solution.
상기 함량보다 과다하게 첨가되는 경우에는, 검체 채취 면봉에 코팅할 때, 얇은 두께로 코팅하기 어려운 문제가 있고, 헤드부의 질감이 저하되어 비인두에 접촉 시 검사 대상자로 하여금 불편함과 비인두 통증을 유발할 수 있는 문제가 있다.If it is added in excess of the above content, there is a problem that it is difficult to coat the sample collection swab with a thin thickness, and the texture of the head part is deteriorated, causing discomfort and nasopharyngeal pain to the test subject when in contact with the nasopharynx. There are problems that can cause it.
상기 함량보다 소량으로 첨가되는 경우에는, 검체 채취 면봉에 코팅은 가능하나, 검체와의 결합력이 낮아, 가벼운 접촉 만으로는 검체의 채취가 어려운 문제가 있어, 일반 시판 신속 항원 검사 키트에 포함된 검체 채취 면봉과 대비하여 효과 차이가 현저하지 않은 문제가 있다.When added in a smaller amount than the above, it is possible to coat the sample collection swab, but the binding force with the sample is low, making it difficult to collect the sample with only light contact. There is a problem that the difference in effect is not remarkable in comparison with
한편, 상기 히알루론산은 10 내지 15 중량부로 첨가될 수 있고, 보다 바람직하게는, 11 내지 14 중량부로 첨가될 수 있다. On the other hand, the hyaluronic acid may be added in 10 to 15 parts by weight, more preferably, 11 to 14 parts by weight.
상기 함량보다 과다한 경우에는, 친수성 용액에서 쉽게 코팅이 벗겨지는 등의 품질 안정성에 문제가 있을 수 있다.If the content exceeds the above, there may be problems with quality stability, such as easy peeling off of the coating in a hydrophilic solution.
상기 함량보다 소량으로 첨가되는 경우에는, 검체와의 결합력 향상 효과가 미미하여, 가벼운 접촉으로 검체의 채취가 어려운 문제가 있다.When added in a smaller amount than the above content, the effect of improving the binding force with the sample is insignificant, and thus, there is a problem in that it is difficult to collect the sample by light contact.
상기 히알루론산은 분자량이 50,000 내지 70,000 Da인 것을 사용할 수 있는데, 상기 분자량보다 큰 경우에는, 점도의 증가로 조성물을 제조하더라도 얇은 두께로 코팅하기 어려운 문제가 있고, 상기 분자량보다 작은 경우에는, 친수성의 저하로 인하여, 검체와의 결합력이 저하되는 문제가 있다.The hyaluronic acid may have a molecular weight of 50,000 to 70,000 Da. If the molecular weight is greater than the molecular weight, it is difficult to coat the composition with a thin thickness even if the composition is prepared due to an increase in viscosity. Due to the decrease, there is a problem that the binding force with the specimen is reduced.
상기 펙틴은 5 내지 7 중량부로 포함될 수 있으며, 상기 함량보다 과량으로 첨가되는 경우에는, 점도의 증가로 인하여 스프레이 코팅방법으로 검체 채취 면봉을 코팅하기 어려워지는 문제가 있고, 상기 함량보다 소량으로 첨가되는 경우에는, 검체와의 결합력이 저하되는 문제가 있다.The pectin may be included in 5 to 7 parts by weight, and when added in excess of the above content, there is a problem in that it is difficult to coat the sample collection swab by the spray coating method due to the increase in viscosity, and added in a smaller amount than the above content In this case, there is a problem in that the binding force with the specimen is lowered.
본 발명에 있어서, 상기 상기 검체 채취 면봉은, 원통형 봉 형태를 가지는 몸체부와 상기 몸체부의일측 단부를 나일론 섬유로 덮어 상기 몸체부보다 두껍게 형성되는 헤드부를 포함하고, 상기 헤드부는 상기 나일론 섬유의 표면에 상기 검체 채취용 조성물이 코팅된 것일 수 있다.In the present invention, the sample collection swab includes a body portion having a cylindrical rod shape and a head portion formed thicker than the body portion by covering one end of the body portion with nylon fiber, and the head portion includes a surface of the nylon fiber. It may be coated with the composition for sampling.
본 발명은 또한, 상술한 검체 채취용 조성물을 이용한 코로나 바이러스 감염 진단 키트로서, 검체 채취용 조성물이 헤드부에 코팅된 검체 채취 면봉, 검체로부터 코로나바이러스를 추출하기 위한 추출 버퍼가 담긴 추출용 용기, 상기 추출 버퍼에 상기 검체 채취 면봉을 침지시켜 얻어진 검출액을 적가하는 검출액 투입부와 코로나 바이러스의 감염 여부를 시각적으로 나타내는 식별부를 구비한 진단 본체를 포함하고, 상기 검체 채취용 조성물은 생리 식염수 100 중량부, 폴리메틸메타크릴레이트(Polymethylmethacrylate, PMMA) 20 내지 30 중량부, 히알루론산 10 내지 15 중량부 및 펙틴 5 내지 7 중량부를 포함하며, 상기 검체 채취 조성물은 상기 검체 채취 면봉의 헤드부에 포함되는 나일론 섬유의 단위 길이당 2 내지 4 mg/m로 코팅된 것인 코로나 바이러스 감염 진단 키트를 제공한다.The present invention is also a coronavirus infection diagnosis kit using the above-described sample collection composition, a sample collection swab coated with the sample collection composition on the head, an extraction container containing an extraction buffer for extracting coronavirus from a sample, A diagnostic main body including a detection solution input unit for dropwise addition of a detection solution obtained by immersing the sample collection swab in the extraction buffer and an identification unit for visually indicating whether or not coronavirus is infected, and the sample collection composition is physiological saline solution 100 20 to 30 parts by weight of polymethylmethacrylate (PMMA), 10 to 15 parts by weight of hyaluronic acid, and 5 to 7 parts by weight of pectin, and the sample collection composition is included in the head of the sample collection swab It provides a coronavirus infection diagnostic kit that is coated with 2 to 4 mg / m per unit length of nylon fiber to be.
상기 검체 채취 조성물은 상기 검체 채취 면봉의 헤드부에 포함되는 나일론 섬유의 단위 길이당 2 내지 4 mg/m로 코팅되는 것이 바람직한데, 상기 코팅량보다 과다하게 코팅되는 경우에는, 추출 버퍼에 넣어 코로나 바이러스를 추출하는 과정에서 추출 버퍼에 검체가 용해되지 못하게 되어, 코로나 바이러스의 추출이 어려워지는 문제가 있을 수 있고, 상기 코팅량보다 소량으로 코팅하는 경우에는, 코팅하지 않은 검체 채취 면봉을 사용하는 경우와 대비하여 효과 차이가 미미한 문제가 있다.The sampling composition is preferably coated at 2 to 4 mg/m per unit length of the nylon fibers included in the head of the sampling swab. In the process of extracting the virus, the sample cannot be dissolved in the extraction buffer, which may make it difficult to extract the corona virus. In contrast, there is a problem that the effect difference is insignificant.
본 발명에 따른 코로나 바이러스 감염 진단 키트에 있어서, 상기 코로나 바이러스 감염 진단 키트는 코로나 바이러스 단백질과 특이적으로 결합하는 항체를 이용한 것이고, 상기 항체는 셀룰로오즈 나노입자가 결합되어 코로나 바이러스 단백질과 항체의 결합 시, 시각적으로 감염 여부의 확인이 가능한 것일 수 있다.In the coronavirus infection diagnosis kit according to the present invention, the coronavirus infection diagnosis kit uses an antibody that specifically binds to a corona virus protein, and the antibody is bound to cellulose nanoparticles and when the corona virus protein and antibody bind , it may be possible to visually confirm the presence of infection.
기존의 대부분 COVID-19 항원 검사의 경우, 면봉을 콧구멍 깊숙이 삽입하여 비인두에서 분비물을 긁어 검체를 채취하는 방식으로 진행됨에 따라 채취 과정에서 환자가 불쾌감을 호소하는 경우가 있었으나, 본 발명은 검체의 고정력이 우수하고, 검체와의 친화력이 보다 향상되어, 비인두를 긁지 않고 간단히 접촉하여 검체를 채취할 수 있으므로, 검체 채취가 상대적으로 용이한 효과를 갖는다.In the case of most existing COVID-19 antigen tests, a cotton swab is inserted deep into the nostril to scrape the secretion from the nasopharynx to collect the sample, so there were cases in which patients complained of discomfort during the collection process. It has excellent fixing power and more improved affinity with the specimen, so that the specimen can be collected by simply contacting the nasopharynx without scratching, so the specimen collection is relatively easy.
본 발명은 또한, 가벼운 접촉으로 검체를 채취하더라도 기존의 신속 항원 검사 키트와 동등한 수준의 진단 성능을 갖는다.In addition, the present invention has diagnostic performance equivalent to that of conventional rapid antigen test kits even when samples are taken by light contact.
이하, 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있도록 본 발명의 각 구성을 보다 상세히 설명하나, 이는 하나의 예시에 불과할 뿐, 본 발명의 권리범위가 다음 내용에 의해 제한되지 아니한다.Hereinafter, each configuration of the present invention will be described in more detail so that those skilled in the art can easily practice it, but this is only one example, and the scope of the present invention is Not limited.
본 발명에 사용된 "바람직한" 또는 "바람직하게는"은 특정 조건에서 특정 장점을 갖는 본 발명의 실시예를 나타낸다. 그러나, 다른 실시예 또한 동일 조건 또는 다른 조건에서 바람직할 수 있다. 또한, 하나 이상의 바람직한 실시예는 다른 실시예가 유용하지 않다는 것을 의미하는 것은 아니며, 본 발명의 범위 내에 있는 다른 실시예를 배제하는 것도 아니다.“Preferred” or “preferably” as used herein refers to embodiments of the present invention that have particular advantages under particular conditions. However, other embodiments may also be preferred under the same or different conditions. Also, the presence of one or more preferred embodiments does not imply that other embodiments are not useful, nor does it exclude other embodiments from being within the scope of the present invention.
본 명세서에 사용된 "포함한다"는 용어는 본 발명에 유용한 재료, 조성물, 장치, 및 방법들을 나열할 때 사용되며 그 나열된 예에 제한되는 것은 아니다.As used herein, the term "comprising" is used when listing materials, compositions, devices, and methods useful in the present invention and is not limited to the examples listed.
본 발명은 코로나 바이러스의 감염 진단을 위한 키트에 적용되는 검체 채취용 조성물에 관한 것으로서, 특히, 검체 채취 도구에 적용하여 사용함으로써, 검체와의 결합력이 우수하여, 가벼운 접촉으로도 검체의 채취가 용이한 장점을 갖는다.The present invention relates to a composition for sampling that is applied to a kit for diagnosing coronavirus infection, and in particular, by applying and using a sample collection tool, it has excellent binding force with a sample, making it easy to collect the sample even with light contact. has one advantage.
이하에서는, 본 발명의 내용을 실시예에 기초하여 보다 상세히 설명한다.Hereinafter, the content of the present invention will be described in more detail based on examples.
제조예manufacturing example
하기 표 1을 참고하여 검체 채취용 조성물을 제조하고, 시판 신속 항원 검사 키트의 검체 채취 면봉(나일론 섬유)의 헤드부에 코팅하여 준비한다. 코팅은 스프레이 코팅하여 얇은 두께로 형성될 수 있도록 하였다.A composition for sampling was prepared with reference to Table 1 below, and prepared by coating the head of a sampling swab (nylon fiber) of a commercially available rapid antigen test kit. The coating was spray coated so that it could be formed in a thin thickness.
비교예 3과 6의 경우, 코팅액의 점도가 높아 스프레이 코팅이 불가함에 따라 코팅 불가함을 별도 표시하였다.In the case of Comparative Examples 3 and 6, since the viscosity of the coating solution is high, spray coating is not possible, so the coating is not possible.
(중량부)content
(parts by weight)
(Da)Molecular Weight
(Da)
실험예 1. 결합력 평가Experimental Example 1. Evaluation of binding force
코로나 바이러스 감염자(신속 항원 검사 5회 수행하여 양성 반응 3회 이상 확인된 감염자)의 비인두 분비물을 1) 원액, 2) 5배 희석액(정제수 희석) 3) 10배 희석액 및 4) 20배 희석액으로 제조하고, 이를 대상 검체로 하여 상기 실시예와 비교예의 검체 채취 면봉를 사용하여 진단 검사를 수행한다.Nasopharyngeal secretions from patients infected with coronavirus (those who tested positive by performing 5 rapid antigen tests and confirmed at least 3 times) were mixed into 1) stock solution, 2) 5-fold dilution (diluted with purified water), 3) 10-fold dilution, and 4) 20-fold dilution. prepared, and a diagnostic test is performed using the sample collection swabs of Examples and Comparative Examples using this as a target sample.
준비된 시판 신속 항원 검사 키트를 활용하여 감염 진단 평가를 진행하고, 양성 반응 여부를 확인하여 하기 표 2에 기재하였다. Infection diagnosis was evaluated using a prepared commercially available rapid antigen test kit, and a positive reaction was confirmed and listed in Table 2 below.
신속 항원 검사 수행방법은 키트에 권고된 방법과 동일한 방법으로 수행하였다.The rapid antigen test was performed in the same way as the method recommended in the kit.
신속 항원 검사의 신뢰도를 고려하여, 각 실시예와 비교예의 키트를 각각 10세트씩 제조하여 준비하고, 실험을 진행한 뒤, 6회 이상 양성인 경우에 (+), 음성인 경우에는 (-)로 표시하였다.Considering the reliability of the rapid antigen test, 10 sets of each of the kits of each example and comparative example were prepared and prepared, and after the experiment, if it was positive 6 or more times, (+), if it was negative, (-) indicated.
(코팅X)reference example
(Coating X)
불가coating
not allowed
불가coating
not allowed
실험예 2. 패널 테스트Experimental Example 2. Panel Test
실시예와 비교예 1 및 2에 대하여, 촉감에 문제가 없으며, 비인두에 특이 질병이 없는 20-30대 성인 남녀 20명을 대상으로 비인두에 가볍게 접촉하였을 때(접촉하는 느낌만 나는 정도)의 촉감을 중심으로 평가를 진행하고 그 결과를 하기 표 3에 기재하였다.With respect to Examples and Comparative Examples 1 and 2, 20 adult men and women in their 20s and 30s without a problem with touch and no specific disease in the nasopharynx were lightly contacted with the nasopharynx (to the extent that they only felt the contact) The evaluation was conducted centering on the tactile sensation of and the results are shown in Table 3 below.
0점(불편함, 아픔)~10점(불편함 없음)으로 점수를 부여하고, 가장 높은 점수와 가장 낮은 점수를 제외하고, 그 외 점수의 평균을 기재하였다.Scores were given on a scale of 0 (discomfort, pain) to 10 (no discomfort), excluding the highest and lowest scores, and the average of the other scores was described.
상기 표 1 내지 3을 참고하면, 실시예의 검체 채취용 조성물을 코팅한 경우에, 희석된 검체로부터 코로나 바이러스의 감염 진단이 가능함을 확인할 수 있다.Referring to Tables 1 to 3, it can be confirmed that the diagnosis of corona virus infection is possible from the diluted specimen when the composition for sampling of the Example is coated.
즉, 비인두에 가벼운 접촉만으로도, 코로나 바이러스의 진단 검사가 가능한 효과를 갖는 것을 확인할 수 있다.That is, it can be confirmed that a diagnostic test for coronavirus has an effect that is possible only by light contact with the nasopharynx.
한편, 실시예의 키트는 패널의 비인두 촉감 평가에서도 좋은 평가를 받았는 바, 검사 대상자의 불편함을 완화할 수 있도록 가벼운 접촉으로 검체의 채취가 가능하여, 코로나 바이러스 진단 검사가 가능한 효과를 가짐을 확인할 수 있다.On the other hand, the kit of the embodiment received a good evaluation in the panel's nasopharyngeal tactile evaluation, and it was confirmed that the sample can be collected by light contact to alleviate the discomfort of the test subject, so that the coronavirus diagnostic test has an effect that can be performed. can
Claims (5)
생리 식염수 100 중량부, 폴리메틸메타크릴레이트(Polymethylmethacrylate, PMMA) 24 중량부, 히알루론산 11 중량부 및 펙틴 5 중량부를 포함하고,
상기 검체 채취 면봉은, 원통형 봉 형태를 가지는 몸체부와 상기 몸체부의 일측 단부를 나일론 섬유로 덮어 상기 몸체부보다 두껍게 형성되는 헤드부를 포함하고,
상기 헤드부는 상기 나일론 섬유의 표면에 상기 검체 채취용 조성물이 나일론 섬유의 단위 길이당 2 mg/m로 코팅된 것이며,
상기 히알루론산은 분자량이 50,000 Da인,
코로나 바이러스 감염 진단 키트에 사용되는 검체 채취용 조성물.
A swab for collecting a sample from the nasopharynx of a test subject; An extraction container containing an extraction buffer for extracting coronavirus from a sample; Corona virus (SARS-CoV-2, ) A composition for sampling used in an infection diagnosis kit,
100 parts by weight of physiological saline, 24 parts by weight of polymethylmethacrylate (PMMA), 11 parts by weight of hyaluronic acid and 5 parts by weight of pectin,
The sample collection swab includes a body portion having a cylindrical rod shape and a head portion formed thicker than the body portion by covering one end of the body portion with nylon fiber,
The head part is coated with the composition for sampling on the surface of the nylon fiber at 2 mg/m per unit length of the nylon fiber,
The hyaluronic acid has a molecular weight of 50,000 Da,
A composition for sampling used in a coronavirus infection diagnostic kit.
검체 채취용 조성물이 헤드부에 코팅된 검체 채취 면봉; 검체로부터 코로나바이러스를 추출하기 위한 추출 버퍼가 담긴 추출용 용기; 상기 추출 버퍼에 상기 검체 채취 면봉을 침지시켜 얻어진 검출액을 적가하는 검출액 투입부와 코로나 바이러스의 감염 여부를 시각적으로 나타내는 식별부를 구비한 진단 본체;를 포함하고,
상기 검체 채취용 조성물은 생리 식염수 100 중량부, 폴리메틸메타크릴레이트(Polymethylmethacrylate, PMMA) 24 중량부, 히알루론산 11 중량부 및 펙틴 5 중량부를 포함하며,
상기 검체 채취 면봉은, 원통형 봉 형태를 가지는 몸체부와 상기 몸체부의 일측 단부를 나일론 섬유로 덮어 상기 몸체부보다 두껍게 형성되는 헤드부를 포함하고,
상기 헤드부는 상기 나일론 섬유의 표면에 상기 검체 채취용 조성물이 나일론 섬유의 단위 길이당 2 mg/m로 코팅된 것이며,
상기 히알루론산은 분자량이 50,000 Da인,
코로나 바이러스 감염 진단 키트.
As a coronavirus infection diagnostic kit,
A sample collection swab coated with a composition for sample collection on the head; An extraction container containing an extraction buffer for extracting coronavirus from a sample; A diagnosis main body having a detection solution injection unit for dropwise addition of a detection solution obtained by immersing the sample collection swab in the extraction buffer and an identification unit for visually indicating whether or not coronavirus is infected;
The sample collection composition includes 100 parts by weight of physiological saline, 24 parts by weight of polymethylmethacrylate (PMMA), 11 parts by weight of hyaluronic acid, and 5 parts by weight of pectin,
The sample collection swab includes a body portion having a cylindrical rod shape and a head portion formed thicker than the body portion by covering one end of the body portion with nylon fiber,
The head part is coated with the composition for sampling on the surface of the nylon fiber at 2 mg/m per unit length of the nylon fiber,
The hyaluronic acid has a molecular weight of 50,000 Da,
Corona virus infection diagnostic kit.
상기 코로나 바이러스 감염 진단 키트는 코로나 바이러스 단백질과 특이적으로 결합하는 항체를 이용한 것이고,
상기 항체는 셀룰로오즈 나노입자가 결합되어 코로나 바이러스 단백질과 항체의 결합 시, 시각적으로 감염 여부의 확인이 가능한 코로나 바이러스 감염 진단 키트.According to claim 4,
The coronavirus infection diagnosis kit uses an antibody that specifically binds to a coronavirus protein,
The antibody is a corona virus infection diagnosis kit that can visually confirm infection when cellulose nanoparticles are bound and when the corona virus protein and antibody are combined.
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