WO2022173204A1 - Dispositifs d'écouvillon pour collecter des prélèvements et procédés pour collecter des prélèvements utilisés pour détecter des agents pathogènes respiratoires - Google Patents

Dispositifs d'écouvillon pour collecter des prélèvements et procédés pour collecter des prélèvements utilisés pour détecter des agents pathogènes respiratoires Download PDF

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Publication number
WO2022173204A1
WO2022173204A1 PCT/KR2022/001948 KR2022001948W WO2022173204A1 WO 2022173204 A1 WO2022173204 A1 WO 2022173204A1 KR 2022001948 W KR2022001948 W KR 2022001948W WO 2022173204 A1 WO2022173204 A1 WO 2022173204A1
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WO
WIPO (PCT)
Prior art keywords
specimen
swab
collecting
swab device
oral
Prior art date
Application number
PCT/KR2022/001948
Other languages
English (en)
Inventor
Jong-Yoon Chun
Seong-Youl Kim
Min Cheol Lee
Original Assignee
Seegene, Inc.
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 Seegene, Inc. filed Critical Seegene, Inc.
Priority to KR1020237023624A priority Critical patent/KR20230118173A/ko
Publication of WO2022173204A1 publication Critical patent/WO2022173204A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6888—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms
    • C12Q1/689—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B10/0096—Casings for storing test samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2527/00—Reactions demanding special reaction conditions
    • C12Q2527/125—Specific component of sample, medium or buffer
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2561/00—Nucleic acid detection characterised by assay method
    • C12Q2561/113—Real time assay

Definitions

  • the present inventors have endeavored to overcome the problems of conventional swab devices for collecting a specimen described above and to develop a swab device for collecting a specimen capable of effectively collecting a nostril swab specimen and/or an oral swab specimen.
  • the present invention is characterized by enabling self-sampling by ordinary persons as non-experts as well as sampling by experts.
  • the gripping part having the above length ranges transmits the force of a specimen collector to the head part through the supporting part, thereby collecting a specimen through the head part.
  • the ratio of the sum of the lengths of the head part 11 and the supporting part 10 to the length of the gripping part 13 may be 1.4-2.9:1, 1.4-2.8:1, 1.4-2.6:1, 1.4-2.5:1, 1.4-2.4:1, 1.4-2.2:1, 1.4-2.0:1, 1.4-1.9:1, 1.6-2.9:1, 1.6-2.8:1, 1.6-2.6:1, 1.6-2.5:1, 1.6-2.4:1, 1.6-2.2:1, 1.6-2.0:1, 1.6-1.9:1, 1.8-2.9:1, 1.8-2.8:1, 1.8-2.6:1, 1.8-2.5:1, 1.8-2.4:1, 1.8-2.2:1, 1.8-2.0:1, 1.8-1.9:1, 1.9-2.9:1, 1.9-2.8:1, 1.9-2.6:1, 1.9-2.5:1, 1.9-2.4:1, 1.9-2.2:1, 2.0:1, 1.8-1.9:1, 1.9-2.9:1, 1.9-2.8:1, 1.9-2.6:1, 1.9-2.5:1, 1.9-2.4:1, 1.9-2.2:
  • the ratio of the lengths of the supporting part 10 , the head part 11 , and the gripping part 13 is 3-5:1:2-2.8.
  • the nostril and/or oral swab specimens can be easily collected by configuring the length of the gripping part to be shorter than the length of the supporting part.
  • the ratio of the lengths of the supporting part, the head part, and the gripping part is 3-5:1:2.0-2.6, 3-5:1:2.0-2.4, 3-5:1:2.0-2.3, 3-5:1:2.1-2.8, 3-5:1:2.1-2.6, 3-5:1:2.1-2.4, 3-5:1:2.1-2.3, 3-5:1:2.2-2.8, 3-5:1:2.2-2.6, 3-5:1:2.2-2.4, 3-5:1:2.2-2.3, 3-5:1:2.3-2.8, 3-5:1:2.3-2.6, 3-5:1:2.3-2.4, 3-5:1:2.4-2.8, 3-5:1:2.4-2.6, 3.1-5:1:2.0-2.8, 3.1-4.7:1:2.0-2.8, 3.1-4.5:1:2.0-2.8, 3.1-4.2:1:2.0-2.8, 3.1-3.9:1:2.0-2.8, 3.1-3.6:1:2.0-2.8, 3.1-3.3:1:2.0-2.8, 3.2-5:1:2.0-2.8, 3.1-
  • the limit length of insertion of the swab device need not be considered since the swab device collects specimens from the posterior walls of the nasopharynx and oropharynx.
  • the delicate positioning of the head part of the swab device at a site of sampling is important for self-sampling by non-experts as well as sampling by experts.
  • a plurality of grooves, protrusions, color bands, or a combination thereof included in the indicating part 14 may be comprised considering the predetermined intervals.
  • the number of grooves, protrusions, color bands, or a combination thereof may be 1-5, 2-5, 2-4, or 3-4.
  • a specimen is collected using the swab device for collecting a specimen and the swab device for collecting a specimen is immersed in a container comprising a specimen transport medium, and then the gripping part is cut at the break point and removed, thereby preventing the contamination of the specimen caused by the gripping part.
  • the ratio of the distance (or length) between the point of action and the point of fulcrum and the distance (or length) between the point of fulcrum and the point of force is 1.4-3.0:1.
  • a swab device for collecting a specimen having a ratio of the predetermined distances on the basis of the point of fulcrum, that is, 1.4-3.0:1, is adopted, so the gripping part can be cut and removed by minimum force after the swab device collecting a specimen is immersed in a container comprising a specimen transport medium.
  • the indicating part indicates a limit length of nasal insertion for each age group.
  • a limit length of nasal insertion for each age group is indicated in the indicating part.
  • the kit for collecting a specimen of the present invention includes the above-described swab device for collecting a specimen of the present invention, the common descriptions between them are omitted in order to avoid undue redundancy leading to the complexity of the present specification.
  • the kit for detecting a respiratory pathogen of the present invention includes the above-described kit for collecting a specimen of the present invention, the common descriptions between them are omitted in order to avoid undue redundancy leading to the complexity of the present specification.
  • nostril swab specimen refers to a swab specimen, which is obtained by applying the swab device to the nostrils and onto which a biopsy specimen from the nostrils is adsorbed, and the term is distinguished from a nasopharyngeal swab specimen.
  • a swab device is inserted into the nostril ( e.g. , insert 2-3 cm) and then a biopsy specimen is collected from the inner portion of the nostril while the swab is smoothly rotated for 10-15 seconds.
  • examples of the buffer include tris(hydroxymethyl)aminomethane, citrate, 2-(N-morpholino)ethanesulfonic acid, N,N-Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid, 1,3-bis(tris(hydroxymethyl)methyl amino)propane, 4-(2-hydroxyethyl)-1-piperazine ethanesulfonic acid, 3-(N-morpholino)propanesulfonic acid, hydroxyethyl piperazine ethane sulfonic acid, bicarbonate, and phosphate.
  • the sequence of the primer is not required to have a perfectly complementary sequence to a partial sequence of the template, and it is enough that the sequence of the primer may have sufficient complementarity within a range in which the primer can do an intrinsic action when hybridized with the template. Therefore, the primers of the present invention do not need to have a perfectly complementary sequence to the above-described nucleotide sequence as a template, and it is sufficient that the primers have sufficient complementarity within a range in which the primers can be hybridized with the gene sequence to act as primers.
  • Such primers can be designed with reference to the above-described nucleotide sequence by a person skilled in the art, and for example, the design may be carried out using a computer program for primer design (e.g. , PRIMER 3 program).
  • influenza viruses e.g. , influenza A virus and influenza B virus
  • RSV respiratory syncytial viruses
  • adenoviruses enteroviruses
  • PIV parainfluenza viruses
  • MPV metapneumoviruses
  • bocaviruses rhinoviruses
  • coronaviruses e.g.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Analytical Chemistry (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Medical Informatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

La présente invention concerne un dispositif d'écouvillon pour collecter un prélèvement et un procédé pour détecter un agent pathogène respiratoire. La présente invention peut facilement et précisément collecter des prélèvements par écouvillonnage nasal et/ou oral à partir de sites de collecte de prélèvements (en particulier, les narines et/ou la cavité orale), peut collecter des quantités suffisantes de prélèvements pour détecter des agents pathogènes respiratoires, peut être utilisée en autonomie par des personnes ordinaires non expertes ainsi que de manière classique par des experts, et peut détecter des agents pathogènes respiratoires à partir des prélèvements collectés par écouvillonnage nasal et oral, par réduction, à une longueur particulière, de la longueur totale du dispositif d'écouvillonnage pour collecter un prélèvement ou par adoption, à une valeur particulière, du rapport de la somme des longueurs d'une partie de tête et d'une partie de support à la longueur d'une partie de préhension, qui constituent le dispositif d'écouvillonnage pour collecter un prélèvement.
PCT/KR2022/001948 2021-02-10 2022-02-09 Dispositifs d'écouvillon pour collecter des prélèvements et procédés pour collecter des prélèvements utilisés pour détecter des agents pathogènes respiratoires WO2022173204A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
KR1020237023624A KR20230118173A (ko) 2021-02-10 2022-02-09 검체 채취 스왑 도구 및 호흡기 병원체를 검출하기위한 검체 채취 방법

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KR20210019204 2021-02-10
KR10-2021-0019204 2021-02-10

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WO2022173204A1 true WO2022173204A1 (fr) 2022-08-18

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PCT/KR2022/001948 WO2022173204A1 (fr) 2021-02-10 2022-02-09 Dispositifs d'écouvillon pour collecter des prélèvements et procédés pour collecter des prélèvements utilisés pour détecter des agents pathogènes respiratoires

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023248098A1 (fr) * 2022-06-21 2023-12-28 Copan Italia S.P.A. Dispositif de collecte d'échantillons biologiques et procédé de collecte d'échantillons biologiques

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120088231A1 (en) * 2007-10-01 2012-04-12 Longhorn Vaccines & Diagnostics, Llc Biological Specimen Collection/Transport Compositions and Methods
US20170231603A1 (en) * 2016-01-13 2017-08-17 The Procter & Gamble Company Oral Sampling Swab And Uses Thereof
KR101786506B1 (ko) * 2009-02-03 2017-10-18 네트바이오, 인코포레이티드 핵산 정제
CN212037598U (zh) * 2020-07-17 2020-12-01 上海市嘉定区安亭医院 一种鼻咽拭子采样管

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120088231A1 (en) * 2007-10-01 2012-04-12 Longhorn Vaccines & Diagnostics, Llc Biological Specimen Collection/Transport Compositions and Methods
KR101786506B1 (ko) * 2009-02-03 2017-10-18 네트바이오, 인코포레이티드 핵산 정제
US20170231603A1 (en) * 2016-01-13 2017-08-17 The Procter & Gamble Company Oral Sampling Swab And Uses Thereof
CN212037598U (zh) * 2020-07-17 2020-12-01 上海市嘉定区安亭医院 一种鼻咽拭子采样管

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
LEE SH , KIM JM: "Coronavirus Disease 2019 (COVID-19): Pandemic and the Challenge of Public Health", KOREAN JOURNAL OF FAMILY PRACTICE, vol. 10, no. 2, 1 April 2020 (2020-04-01), pages 87 - 95, XP009532619, ISSN: 2233-9019, DOI: 10.21215/kjfp.2020.10.2.87 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023248098A1 (fr) * 2022-06-21 2023-12-28 Copan Italia S.P.A. Dispositif de collecte d'échantillons biologiques et procédé de collecte d'échantillons biologiques

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