WO2022040785A1 - Dispositif de prélèvement soluble dans un liquide pour le criblage de micro-organismes - Google Patents

Dispositif de prélèvement soluble dans un liquide pour le criblage de micro-organismes Download PDF

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Publication number
WO2022040785A1
WO2022040785A1 PCT/CA2021/051163 CA2021051163W WO2022040785A1 WO 2022040785 A1 WO2022040785 A1 WO 2022040785A1 CA 2021051163 W CA2021051163 W CA 2021051163W WO 2022040785 A1 WO2022040785 A1 WO 2022040785A1
Authority
WO
WIPO (PCT)
Prior art keywords
soluble
swab
collection
solubilizing
coating
Prior art date
Application number
PCT/CA2021/051163
Other languages
English (en)
Inventor
Seyed Hassan Hosseini
Deryck Francis HART Jr.
Scott O'HEARN
Original Assignee
Green Belting Industries Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Green Belting Industries Ltd. filed Critical Green Belting Industries Ltd.
Publication of WO2022040785A1 publication Critical patent/WO2022040785A1/fr

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Classifications

    • 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
    • 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
    • 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0216—Sampling brushes

Definitions

  • This invention pertains generally to methods and devices for detecting and/or identifying microorganisms in a biological sample and, more particularly to a liquid soluble collection device for microorganism screening.
  • sample collection from the mouth, nose, throat, and other locations may be accomplished by brushing or wiping a body surface with a swab.
  • some diseases may be detected by analysis of swabs, or fluid obtained from swabs, such as throat swabs, nasal swabs, cheek swabs, or other swabs, such as, COVID-19, influenza and other respiratory disorders; tuberculosis; bacterial infections such as diphtheria, whooping cough, and those caused be caused by staphylococcus, streptococcus, pneumococcus, and other bacteria; viral infections, such as, e.g., adenovirus infections; some genetic diseases caused by or related to a subject's genetic characteristics; and other diseases and disorders.
  • Analysis of the sample typically requires that the collected fluid or tissue be transferred from the swab to a vessel, slide, or analysis device. However, such transfer is often incomplete, and loss or degradation of the sample may occur before analysis. Accordingly, improved swabbing methods and swab collection devices are required.
  • An object of the present invention is to provide a liquid soluble collection device for microorganism screening.
  • a biological specimen collection swab comprising a rod, terminating in a tip; and a soluble layer coating said tip.
  • a biological specimen collection system comprising the swab of the invention and a container for receiving a swab, optionally the container comprises a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer.
  • a collection swab comprising: a substrate comprising paper or an aramid polymer, the substrate comprising a surface having a collection area to be placed against a surface from which a sample is collected; and a soluble coating disposed on the surface of the substrate in the collection area.
  • a collection card comprising a substrate comprising paper or an aramid polymer, the substrate comprising a surface having a plurality of collection areas marked thereon; and a soluble coating disposed on the surface of the substrate in each collection area.
  • a method of collecting a biological sample for analysis comprising, contacting a biological surface with the tip of the swab of the invention, and solubilizing or dissolving the soluble layer with a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer and; wherein the biological surface is optionally a nasal or oral surface.
  • a method of collecting a sample for analysis comprising, contacting a surface with the collection swab of the invention, and solubilizing or dissolving the soluble layer with a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer.
  • the surface is a non-biological surface and optionally a frequent contact surface such a door knob.
  • FIG. 1 illustrates a biological specimen collection swab in accordance with an aspect of the invention.
  • FIG. 2 illustrates a biological specimen collection system in accordance with an aspect of the invention.
  • FIG. 3 illustrates a collection swab in accordance with an aspect of the invention.
  • FIG. 4 illustrates a collection card for multiple samples.
  • the specimens or samples are collected from humans. In other embodiments, the specimens or samples are collected from animals.
  • the present invention provides an improved swab and collection system for specimen or sample collection.
  • Specimen or samples collected include those obtained by nasal or throat swabs, saliva, blood or serum.
  • the specimens or samples are collected from humans. In other embodiments, the specimens or samples are collected from animals.
  • samples include surface wipes including surface wipes of high touch areas such as door handles.
  • the swabs of the invention can be used in screening for microorganisms including bacteria, virus and fungi.
  • the swabs of the invention can be used in routine sample collection including blood and saliva collection.
  • the swabs of the invention comprise material that dissolves or is solubilized when immersed in a solubilizing liquid or solution thereby substantially transferring the majority or all of the collected material to the solution.
  • the material dissolves at a lower temperature, for example, about 5°C to about 40°C, in some embodiments, material dissolves at room temperature.
  • the solubilizing liquid or solution is water or an aqueous solution.
  • the aqueous solutions pH is adjusted to promote solubilizing of the material.
  • the dissolvable or soluble material may be any material that dissolves and does not impact the downstream diagnostic testing.
  • the material can be in the form of a coating, a fabric (either woven or non-woven) or a film (including 1 to 250 gsm basis weight).
  • the material can be spun, optionally into filaments, into a padding or cotton ball like material.
  • the dissolvable or soluble material includes aqueous-soluble polymer, Alkali-soluble polymer including but not limited to Ethylene-vinyl acetate (EVA), Polyvinyl Alcohol (PVA), Polyamide (PA), Polyester (PET) or protein base fiber.
  • EVA Ethylene-vinyl acetate
  • PVA Polyvinyl Alcohol
  • PA Polyamide
  • PET Polyester
  • the material is ethylene-vinyl acetate (EVA).
  • the biological specimen collection swab comprises a rod, terminating in a tip; and a soluble layer comprising ethylene-vinyl acetate (EVA) coating the tip.
  • the materials are hydrophilic in nature to facilitate water permeation through the material.
  • the swab may be coated with a material that absorbs and attracts microorganisms.
  • the swabs may have an electrostatic surface coating to attract more microorganisms to improve harvesting and detection accuracy.
  • the swab may be stored for a period of time prior to processing.
  • the swab may be stored in the solubilizing liquid.
  • the solubilizing liquid will depend on the material used.
  • the solubilizing liquid is an aqueous solution, the pH of which may be adjusted based on the characteristics of the material.
  • the material is soluble at an alkaline pH.
  • Specimen or samples collected by the improved swab or collection system are processable by means known in the art including PCR based methods, antibody, antigen or proteinbased methods.
  • the swab is part of a kit that includes detection reagents.
  • the solubilizing solution is specifically configured for the screening or testing protocol used. Accordingly, in some embodiments, the solution includes one or more of buffer agents, alcohol, surfactants, chaotropes, detergents, defoaming agents and reducing agents.
  • the solubilizing solution includes one or more primers, probes, labels, enzymes and other reagents known in the art.
  • the invention provides a biological specimen collection swab (10).
  • the swab includes a rod (12) and head or tip.
  • the rod may be manufactured from rolled paper, plastic, wood or material that would be known in the art.
  • the head includes a substrate (14) that is coated with the dissolvable or soluble material (16).
  • the entire head is manufactured from the dissolvable or soluble material.
  • the head is coated with an electrostatic material.
  • the invention provides biological specimen collection system (20) comprising a collection swab (10), storage container (15) with lid or cap (30).
  • the cap (30) includes a hole, optionally with a seal, for the rod of the swab. In alterative embodiments, the cap completely closes the container.
  • the storage container (15) is optionally filed with the solubilizing solution (25) or alternative storage solution.
  • the invention provides collection swab (40) comprising a substrate (45) and dissolvable or soluble material coating (50).
  • the substrate is generally flexible and may be manufactured from a variety of woven and non-woven materials.
  • the substrate is paper product.
  • the invention provides a collection card (60) for multiple samples comprising a generally stiff or non-flexible substrate (70) printed with marked and optionally perforated sample spots (65). Each sample is coated with the dissolvable or soluble material. During processing, individual sample spots are placed in the solubilizing material.
  • This embodiment is specifically designed for screening large number of animals, for example, in a farm setting where blood samples from animals are blotted on the sample spot for later processing.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

L'invention concerne un écouvillon et un système de prélèvement d'échantillon biologique comprenant une matière qui se dissout ou est solubilisée lorsqu'elle est immergée dans une solution, ce qui permet de transférer sensiblement la majorité ou la totalité de la matière prélevée dans la solution pour en faciliter le traitement. La matière soluble comprend de l'éthylène-acétate de vinyle (EVA), de l'alcool polyvinylique (PVA), du polyamide (PA) ou du polyester (PET).
PCT/CA2021/051163 2020-08-28 2021-08-23 Dispositif de prélèvement soluble dans un liquide pour le criblage de micro-organismes WO2022040785A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063071425P 2020-08-28 2020-08-28
US63/071,425 2020-08-28

Publications (1)

Publication Number Publication Date
WO2022040785A1 true WO2022040785A1 (fr) 2022-03-03

Family

ID=80353971

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2021/051163 WO2022040785A1 (fr) 2020-08-28 2021-08-23 Dispositif de prélèvement soluble dans un liquide pour le criblage de micro-organismes

Country Status (1)

Country Link
WO (1) WO2022040785A1 (fr)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070255175A1 (en) * 2006-04-14 2007-11-01 Sangha Jangbir S Low pressure sample collection apparatus
JP2008132011A (ja) * 2006-11-27 2008-06-12 Glory Sangyo Kk 親水性連続多孔質体からなる綿棒
WO2011133129A1 (fr) * 2010-04-21 2011-10-27 Puritan Medical Products Company, Llc Dispositif et matériaux de collecte
US8911680B2 (en) * 2006-12-29 2014-12-16 Preanalytix Gmbh Device for collecting and triggered release of a biological sample
CN204106050U (zh) * 2013-09-06 2015-01-21 特斯托股份公司 拭子
JP2016109590A (ja) * 2014-12-08 2016-06-20 広陵化学工業株式会社 生物学的検体採取用スワブ及びその製造方法
US20180021771A1 (en) * 2015-02-17 2018-01-25 Bio-Marketing-T, Ltd. (BMT) Devices for biological sample collection and analysis and methods of use thereof
US20180127740A1 (en) * 2012-07-13 2018-05-10 Diomics Corporation Biologic sample collection devices and methods of production and use thereof
US20180361375A1 (en) * 2015-11-03 2018-12-20 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
CN110384522A (zh) * 2018-04-16 2019-10-29 南京福怡科技发展股份有限公司 一种全新功能的细胞学dna检测样本采集拭子
US20200088607A1 (en) * 2017-01-13 2020-03-19 Luna Innovations Incorporated Dissolvable nanofiber materials and specimen recovery kits including the same for high efficiency specimen recovery
JP2020060397A (ja) * 2018-10-05 2020-04-16 広陵化学工業株式会社 検体採取スワブ

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070255175A1 (en) * 2006-04-14 2007-11-01 Sangha Jangbir S Low pressure sample collection apparatus
JP2008132011A (ja) * 2006-11-27 2008-06-12 Glory Sangyo Kk 親水性連続多孔質体からなる綿棒
US8911680B2 (en) * 2006-12-29 2014-12-16 Preanalytix Gmbh Device for collecting and triggered release of a biological sample
WO2011133129A1 (fr) * 2010-04-21 2011-10-27 Puritan Medical Products Company, Llc Dispositif et matériaux de collecte
US20180127740A1 (en) * 2012-07-13 2018-05-10 Diomics Corporation Biologic sample collection devices and methods of production and use thereof
CN204106050U (zh) * 2013-09-06 2015-01-21 特斯托股份公司 拭子
JP2016109590A (ja) * 2014-12-08 2016-06-20 広陵化学工業株式会社 生物学的検体採取用スワブ及びその製造方法
US20180021771A1 (en) * 2015-02-17 2018-01-25 Bio-Marketing-T, Ltd. (BMT) Devices for biological sample collection and analysis and methods of use thereof
US20180361375A1 (en) * 2015-11-03 2018-12-20 Copan Italia S.P.A. Device for collecting, transferring, and storing samples of a biological and/or chemical material
US20200088607A1 (en) * 2017-01-13 2020-03-19 Luna Innovations Incorporated Dissolvable nanofiber materials and specimen recovery kits including the same for high efficiency specimen recovery
CN110384522A (zh) * 2018-04-16 2019-10-29 南京福怡科技发展股份有限公司 一种全新功能的细胞学dna检测样本采集拭子
JP2020060397A (ja) * 2018-10-05 2020-04-16 広陵化学工業株式会社 検体採取スワブ

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
NATARAJAN ARUNKUMAR: "Photo-dissolvable Swabs for Improved Recovery of Forensic Samples", NCJRS NATIONAL CRIMINAL JUSTICE REFERENCE SERVICE, 21 July 2019 (2019-07-21), XP055909295, Retrieved from the Internet <URL:https://www.ojp.gov/pdffiles1/nij/grants/253069.pdf> *
TROTT P. A., WILLIAMS G., ATTRIDGE P. W.: "Use of soluble swabs in the diagnosis of bladder neoplasia", JOURNAL OF CLINICAL PATHOLOGY, BMJ PUBLISHING GROUP, GB, vol. 22, no. 6, 1 November 1969 (1969-11-01), GB , pages 731 - 736, XP055909296, ISSN: 0021-9746, DOI: 10.1136/jcp.22.6.731 *

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