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WO1994003111A1 - Procede d'obtention d'un echantillon cellulaire non liquide - Google Patents

Procede d'obtention d'un echantillon cellulaire non liquide Download PDF

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Publication number
WO1994003111A1
WO1994003111A1 PCT/US1993/007382 US9307382W WO9403111A1 WO 1994003111 A1 WO1994003111 A1 WO 1994003111A1 US 9307382 W US9307382 W US 9307382W WO 9403111 A1 WO9403111 A1 WO 9403111A1
Authority
WO
WIPO (PCT)
Prior art keywords
brush
cells
bristles
membrane
animal
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/US1993/007382
Other languages
English (en)
Inventor
Katherine W. Klinger
Brenda L. Richards
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.)
Genzyme Corp
Original Assignee
Genzyme Corp
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 Genzyme Corp filed Critical Genzyme Corp
Priority to JP6505572A priority Critical patent/JPH08501228A/ja
Priority to EP93919898A priority patent/EP0653920A1/fr
Publication of WO1994003111A1 publication Critical patent/WO1994003111A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/24Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING 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
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6806Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/0051Devices for taking samples of body liquids for taking saliva or sputum samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0216Sampling brushes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/32Surgical cutting instruments
    • A61B2017/320004Surgical cutting instruments abrasive
    • A61B2017/320012Brushes

Definitions

  • cervicovaginal lavage was found to be superior to scrape, swab or brush methods for obtaining cervicovaginal cells (Goldberg, GL et. al., Am. J. Obstet. Gynecol. 161 : 1169-72 (1989); Vermund, SH et. al., Ann. J. Obstet. Gynecol. 160: 304-8 (1989)).
  • cervicovaginal cells obtained by lavage are in a liquid format and therefore present the same problems with handling, processing and contamination as samples obtained by mouthwashing techniques.
  • DNA has been obtained from epithelial cells, spun from urine (Gasparinin, P. et. al., N. Engl. J. Med. 320: 809 (1989)); and from root and surrounding sheath cells obtained from plucked hairs (Higuchi, R. et. al.. Nature 332:543-6 (1988)).
  • samples so obtained often do not contain enough DNA for genetic analysis. Therefore hair and urine samples are not optimal for clinical analysis.
  • a simple, noninvasive technique for obtaining a non-liquid cell sample having an appropriate amount of genetic material for clinical analysis would be useful.
  • the invention relates to a simple, noninvasive process for obtaining a non- liquid cell sample from an animal for genetic analysis.
  • the process involves inserting an appropriately sized brush into an animal's oral cavity, contacting the brush with an oral membrane, agitating the brush against the membrane so that cells are captured within the bristles of the brush, removing the brush, which contains the captured cells and isolating the cells from the bristles of the brush for use in genetic analysis.
  • the brush is spiral, so that cells can be obtained by rotating the brush against an oral membrane.
  • Cells so obtained can then be analyzed using any of a number of known genetic techniques. For example, cells obtained according to the disclosed method can be lysed and the cell's DNA can be contacted with a suitable labelled probe. In addition, DNA so obtained can first be amplified to increase the amount of genetic material available for analysis.
  • a major advantage of using the process described herein for obtaining cells for genetic testing is that the non-liquid sample so obtained is easier to handle and to process than a liquid sample. Further a non-liquid sample is less prone to contamination (e.g by bacteria) and is more stable.
  • the invention relates to a process for obtaining a non-liquid cell sample from an animal (e.g. a human or a domesticated mammal) for genetic analysis.
  • the process employs a brush to obtain cells from within a animal's oral cavity.
  • Examples of cells which can be obtained from an animal's oral cavity include epithelial cells of the inner cheek or tongue.
  • a brush is inserted into an animal's oral cavity, contacted with an oral membrane and agitated (e.g. rotated or brushed) against the membrane for a sufficient period of time, so that cells are captured within the bristles of the brush.
  • the brush, which contains captured cells is then removed from the animal's mouth and cells are isolated from the bristles of the brush for use in genetic analysis.
  • a brush must be of an appropriate size to enable insertion into the animal's oral cavity.
  • the brush bristles should be free of potentially contaminating material.
  • a brush comprising mammalian hair should not be used in the subject method, because genetic material present within the hair could contaminate the sample and thereby interfere with the genetic analysis.
  • Preferred brushes for use in the subject invention have synthetic (e.g. nylon or dacron) bristles.
  • An especially preferred brush for use in the invention is the nylon bristle cytology brush, (Cytosoft Medical Packaging Corporation, Camarillo, CA), which is currently used for Pap Smear and Chiamydia testing.
  • a brush which contains captured oral cells can be analyzed directly or transported and/or stored for subsequent genetic analysis.
  • measures aimed at avoiding the dislodging of captured cells from a brush should be taken.
  • the brush can be placed in a container (e.g. an envelope) during transportation and/or storage.
  • Cells may be obtained from a brush by any method which avoids loss of captured cells.
  • a preferred method of obtaining cells from the brush is by contacting the cells with a solution.
  • the ceils can be obtained from the brush using a solution which lyses cells (e.g. sodium hydroxide, potassium hydroxide).
  • Genetic material from oral cells so obtained can then be analyzed genetically using any of a number of known genetic techniques, such as digestion with restriction endonucleases, ultraviolet light visualization of ethidium bromide stained agarose gels, DNA sequencing, or hybridization with detectable nucleic acid sequences (e.g. labelled probes).
  • the genetic material from cells obtained according to the disclosed method can be amplified using known amplification techniques, such as Q-beta-replicase and the poiymerase chain reaction (PCR) (Saiki, R.K. et. al.. Science 239:487-491 (1988); Wong, C, et. al.. Nature 330, 384-386 (1987) and U.S. Patent 4,683,202 to Muilis et. al.) to further increase the amount of genetic material available for genetic analysis.
  • known amplification techniques such as Q-beta-replicase and the poiymerase chain reaction (PCR) (Saiki, R.K. et
  • Example 1 Obtaining Cells From Oral Cavities Using either a Brush or a Wooden Spatula
  • the oral cavities of five human subjects were scraped with wooden spatulas for about 30 seconds, and in five human subjects, the CytosoftTM nylon bristle cytology brushes (Medical Packaging Corporation; Camarilo, CA) were rotated against the inner side of their cheeks for about 30 seconds.
  • the spatulas or brushes were soaked in test tubes containing 50mM NaOH for about 1 hour, after which one tenth volume of IM TRIS (pH8) was added to the test tubes to neutralize.
  • the cheek cell lysates obtained using the spatulas or the brushes were used directly in a poiymerase chain reaction (PCR) to amplify one or more of the following exons of the Cystic Fibrosis transmembrane regulator gene: exons 4, 10, 1 1 , 20 and 21.
  • Apropriate primers for the PCR were developed based on the nucleic acid sequence disclosed in Riordan, J.R. et al.. Science 245: 1066-1073 (1989).
  • PCR amplification reactions were performed using AmpliTaq DNA poiymerase and a DNA Thermal Cycler (Perkin Elmer). Cheek lysates were amplified for 28 cycles of 10 seconds at 94°, 10 seconds 55°C, and 30 seconds at

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

Procédé simple, non invasif d'obtention d'un échantillon cellulaire non liquide à l'aide d'une brosse, aux fins de l'analyse génétique.
PCT/US1993/007382 1992-08-07 1993-08-05 Procede d'obtention d'un echantillon cellulaire non liquide Ceased WO1994003111A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP6505572A JPH08501228A (ja) 1992-08-07 1993-08-05 非液体細胞試料の採取方法
EP93919898A EP0653920A1 (fr) 1992-08-07 1993-08-05 Procede d'obtention d'un echantillon cellulaire non liquide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US92987192A 1992-08-07 1992-08-07
US07/929,871 1992-08-07

Publications (1)

Publication Number Publication Date
WO1994003111A1 true WO1994003111A1 (fr) 1994-02-17

Family

ID=25458604

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1993/007382 Ceased WO1994003111A1 (fr) 1992-08-07 1993-08-05 Procede d'obtention d'un echantillon cellulaire non liquide

Country Status (4)

Country Link
EP (1) EP0653920A1 (fr)
JP (1) JPH08501228A (fr)
CA (1) CA2137282A1 (fr)
WO (1) WO1994003111A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995019447A1 (fr) * 1994-01-14 1995-07-20 The Jockey Club Procede d'echantillonnage non invasif pour analyse d'acides nucleiques
EP0956083A4 (fr) * 1995-11-15 2000-07-05 Genelink Inc Dispositif non invasif d'identification
US9968247B2 (en) 2014-05-02 2018-05-15 United States Endoscopy, Inc. Cleaning device for an endoscopic device

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2363833C (fr) * 1999-02-23 2007-04-03 Oralscan Laboratories, Inc. Appareil et methode peu effractifs de test de lesions de la cavite orale et de l'epithelium similaire
JP2016045103A (ja) * 2014-08-25 2016-04-04 日東電工株式会社 ガスクロマトグラフィー質量分析用試料サンプリング材
JP2016045102A (ja) * 2014-08-25 2016-04-04 日東電工株式会社 高速液体クロマトグラフィー用試料サンプリング材

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2839049A (en) * 1954-03-25 1958-06-17 Kenneth S Maclean Abrasive cytologic brush
GB2159420A (en) * 1984-05-29 1985-12-04 Medscand Ab Endocervical sampling brush and smear method
WO1992007955A1 (fr) * 1990-10-26 1992-05-14 Orion-Yhtymä Oy Procede servant a evaluer si des eprouvettes cliniques conviennent a des analyses d'hybridation et kit servant a effectuer l'evaluation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2839049A (en) * 1954-03-25 1958-06-17 Kenneth S Maclean Abrasive cytologic brush
GB2159420A (en) * 1984-05-29 1985-12-04 Medscand Ab Endocervical sampling brush and smear method
WO1992007955A1 (fr) * 1990-10-26 1992-05-14 Orion-Yhtymä Oy Procede servant a evaluer si des eprouvettes cliniques conviennent a des analyses d'hybridation et kit servant a effectuer l'evaluation

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
N.LENCH ET AL.: "Simple non-invasive method to obtain DNA for gene analysis", THE LANCET, vol. 1, 18 June 1988 (1988-06-18), pages 1356 - 1358 *
R.D.BURK ET AL.: "Genetic screening with exfoliated cervicovaginal cells collected by a noninvasive lavage technique performed during routine gynecologic cancer screening", AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, vol. 162, no. 3, March 1990 (1990-03-01), pages 652 - 654 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995019447A1 (fr) * 1994-01-14 1995-07-20 The Jockey Club Procede d'echantillonnage non invasif pour analyse d'acides nucleiques
EP0956083A4 (fr) * 1995-11-15 2000-07-05 Genelink Inc Dispositif non invasif d'identification
US9968247B2 (en) 2014-05-02 2018-05-15 United States Endoscopy, Inc. Cleaning device for an endoscopic device

Also Published As

Publication number Publication date
CA2137282A1 (fr) 1994-02-17
JPH08501228A (ja) 1996-02-13
EP0653920A1 (fr) 1995-05-24

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