WO2002080775A1 - Procédé de prélèvement d'un échantillon du tractus gastro-intestinal - Google Patents

Procédé de prélèvement d'un échantillon du tractus gastro-intestinal Download PDF

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Publication number
WO2002080775A1
WO2002080775A1 PCT/AU2002/000419 AU0200419W WO02080775A1 WO 2002080775 A1 WO2002080775 A1 WO 2002080775A1 AU 0200419 W AU0200419 W AU 0200419W WO 02080775 A1 WO02080775 A1 WO 02080775A1
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WO
WIPO (PCT)
Prior art keywords
sample
patient
gastrointestinal tract
wash
collected
Prior art date
Application number
PCT/AU2002/000419
Other languages
English (en)
Inventor
Howard Milne Chandler
Original Assignee
Enterix 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 Enterix Inc. filed Critical Enterix Inc.
Publication of WO2002080775A1 publication Critical patent/WO2002080775A1/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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • 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
    • A61B2010/0061—Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
    • 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 relates to a method for collecting a sample from a patient for subsequent use in a detection of an analyte in the sample.
  • this invention relates to a method for collecting a sample from the lower gastrointestinal tract of a patient for the purposes of subsequent detection in the sample of occult blood or one or more other indicators of a pathological condition such as colorectal cancer.
  • CRC Colorectal cancer
  • guaiac also known as gum guaiac or resin guaiac
  • the faecal occult blood test (FOBT) most commonly used in clinical practice is Hemoccult II (SmithKline Diagnostics, San Jose, California, USA), which is a guaiac-based test that detects occult blood in a faecal sample on the basis of the pseudoperoxidase activity of heme or haemoglobin.
  • Hydrogen peroxide in the developing reagent converts colourless guaiac to a blue colour in the presence of pseudoperoxidase activity.
  • Other chromogens which may be used instead of guaiac in these tests include orhodianiside and tetramethylbenzidine. It should be noted that a positive FOBT is not specific for cancer or blood as other causes of gastrointestinal bleeding (i.e. gastritis, peptic ulcer disease, etc.) and other substances (red meat, raw vegetables, etc.) can cause a false positive result.
  • Prior Australian Patent No. 665956 International Patent Application No.
  • PCT/US92/044205 notes that among the many analytical systems used for detection and/or determination of analytes, particularly analytes of biological interest, are chromatographic assay systems.
  • analytes of biological interest frequently assayed with such chromatographic assay systems are proteins, such as haemoglobin, assayed in determinations of faecal occult blood as an early indicator of gastrointestinal disorders such as colorectal cancer.
  • Such chromatographic assay systems are frequently used by physicians and medical technicians for rapid in-office diagnosis and therapeutic monitoring of a variety of conditions and disorders. They are also increasingly used by patients themselves for at-home monitoring of such conditions and disorders.
  • chromatographic systems include the "thin layer" membrane-based systems in which a solvent moves as a solvent front across a thin, flat absorbent medium (e.g., nitrocellulose membrane).
  • a thin, flat absorbent medium e.g., nitrocellulose membrane.
  • immunoassays which depend on the specific interaction between an antigen or hapten and a corresponding antibody. The use of immunoassays as a means of testing for the presence and/or amount of clinically important molecules has been known for some time.
  • Chromatographic techniques used in conjunction with immunoassays include a procedure known as immunochromatography.
  • this technique uses a disclosing reagent or particle that has been linked to an antibody which is specific to the analyte to be assayed, forming a conjugate.
  • This conjugate is then mixed with a specimen and, if the analyte to be assayed is present in the specimen, the disclosing reagent-linked antibodies bind to the analyte to be assayed, thereby giving an indication that the analyte to be assayed is present.
  • the disclosing reagent or particle can be identifiable by colour, magnetic or fluorescent properties, radioactivity, specific reactivity with another molecule, or another physical or chemical property. The specific reactions that are employed vary with the nature of the analyte being assayed and the sample to be tested.
  • the present invention is particularly, but not exclusively, directed to collection of samples from the lower gastrointestinal (Gl) tract of a patient for occult blood detection, for example in screening for colorectal cancer.
  • Gl gastrointestinal
  • guaiac- or other chromogen-based testing provides a colorimetric assay system for detection of haemoglobin in a sample, however because of the large number of false positives obtained in guaiac testing, the use of two or three guaiac tests has been recommended in screening programs , confirmed when positive by an immunological test for human haemoglobin (Favennic L, Kapel N., Meillet D., Chochillon C.
  • a method for collecting a sample from a patient which comprises collecting a sample directly from the lumen of the lower gastrointestinal tract of the patient.
  • references to collecting a sample directly from the lumen of the lower gastrointestinal tract of a patient are to be understood as referring to intra-rectal collection of the sample from the patient, for example, by a lower rectal lavage or wash procedure or by use of a swab, brush or similar collecting device introduced into the lower rectum of the patient, as described below.
  • the present invention provides a method for detecting a pathological condition or disease in the gastrointestinal tract of a patient, which comprises the steps of:
  • the pathological condition may be, for example, colorectal cancer
  • the analyte detected in the sample is occult blood (which may be detected by guaiac- or other chromogen-based tests and/or immunochromatographic assays for haemoglobin).
  • occult blood which may be detected by guaiac- or other chromogen-based tests and/or immunochromatographic assays for haemoglobin.
  • an immuno- chromatographic test for haemoglobin is preferred.
  • a guaiac-based component to the test may assist in protecting against a false negative result in an immunoassay due to a prozone effect arising from sampling a high concentration of blood (see, for example, International Patent Application No. PCT/AU99/014014 - Publication No. WO 00/29852 - the contents of which are incorporated herein by reference).
  • the present invention provides a method for detection of occult blood as indicative of a pathological condition or disease in the gastrointestinal tract of a patient, which comprises the steps of:
  • the collected sample may comprise cells and/or cell debris which may be subjected to cytological examination, and/or free proteins, nucleic acids and their degradation products, all of which may be useful for analysis for indications of colorectal cancer or other gastrointestinal pathologies or diseases.
  • the sample is collected directly from the lumen of the patient's lower gastrointestinal tract, preferably by a lavage or wash procedure as described below.
  • the sample may be a directly representative sample of the contents of the lower gastrointestinal tract which can be expected to include any residual occult blood or other indicators of a pathological condition or disease transported into the lower region of the gastrointestinal tract by stool passage from higher up the gastrointestinal tract.
  • the sample is collected by a lower rectal lavage or wash procedure in which a suitable wash fluid is introduced into the lower rectum to wash the inner wall of the gastrointestinal tract, and the wash fluid is subsequently aspirated and collected as the sample for subsequent testing.
  • Suitable wash fluids include both water and saline.
  • the wash fluid may also contain compatible surfactants, buffers, and similar additives.
  • the sample may be collected directly using a fibre- tipped swab, or a brush or similar collecting device having flexible or semi-flexible bristles which is inserted into the lower rectum to obtain a direct sample.
  • the swab, brush or other collecting device is then added to a fluid in a test tube or similar reagent container to transfer the sample into the fluid for subsequent testing.
  • This fluid may also be used to lubricate the swab, brush or other collecting device prior to collection of the sample.
  • the fluid contains a compatible surfactant both to act as a lubricant for the collecting device and to assist in the extraction and dispersion of the collected sample for subsequent testing.
  • the present invention is particularly useful in faecal occult blood testing as described in detail herein, it is to be understood that the method as broadly described herein may be used to obtain a sample from the lower Gl tract for subsequent testing to detect the presence of one or more other indicators of a pathological condition, for example, tumour-derived antigens, in addition to or instead of faecal occult blood testing.
  • the method of this invention may also be used to recover cellular debris, DNA, RNA or the like in the sample for subsequent analysis, for example, for molecular markers of cancer and other pathological conditions, or for the presence of pathogens.
  • a variety of formats for the faecal occult blood (FOB) test are known in the art (see, for example, US Patent Nos. 3996006; 4225557; 4789629; 5064766; 5100619; 5106582; 5171528; 5171529; and 5182191).
  • the majority of test formats are based on the chemical detection of the heme groups present in faecal material as a breakdown product of blood.
  • the pseudoperoxidase nature of the heme group is used to catalyse a colorimetric reaction between an indicator dye and peroxide.
  • the oxygen sensitive dye can be gum guaiac, orthodianisidine, tetramethylbenzidine, or the like, with guaiac being preferred.
  • WO 99/56103 discloses the use of a brush or brush-like device having flexible or semi-flexible bristles as a device for obtaining a sample derived from faecal material, and particularly stool, in fluid such as water, particularly for the detection of occult blood as an indicator of colorectal cancer (CRC) or its precursor conditions. If the stool or other faecal material is sampled in a fluid, for example, when it is in the water of the toilet bowl, there is a better opportunity to gain a representative sampling of the whole stool. This is particularly the case where a small brush (e.g. a small artist's paint brush having bristles about 1 to 2 cm in length) is used for sampling.
  • a small brush e.g. a small artist's paint brush having bristles about 1 to 2 cm in length
  • a brush may be used to "paint" the surface of the stool so as to displace any blood on the surface of the stool into the water surrounding the stool.
  • the flexible or semi-flexible bristles of the brush will be relatively “open” during this brushing and sampling process, but will “close” as the brush is withdrawn from the water, thereby keeping a sample of the water (and any blood contained therein), surrounding the stool within the interstitial spaces of the bristles. This sample may then be transferred to a suitable assay device for subsequent testing.
  • colorectal cancers and adenomas often bleed into the lumen of the large bowel. Initially, only a small, localised amount of blood leakage may occur, leading to isolated spots or areas of blood occurring on the surface of faecal material in the large bowel which will be exposed to the blood first. Similarly, almost all colorectal cancers and all adenomas occupy only a small portion of the diameter of the large bowel. Therefore, it is also likely that the blood from such lesions will be striped along the faecal material.
  • Collection of a sample from the surface of faecal material as described above has the disadvantage that it relies on patient compliance in obtaining appropriate samples for FOBT testing. Furthermore, since it relies on detecting occult blood on the surface of the faecal material, and any blood present may not be evenly distributed over the surface, there is a real possibility that a surface sample may not sample from that area of the surface where blood is present, leading to a false negative test result.
  • DRE Direct rectal examination
  • the direct sampling of the lower gastrointestinal tract in accordance with the present invention may be performed at the same time as DRE of the patient, for example by use of a modified medical examination glove or fingerstall which is specially adapted to directly sample the lower Gl tract in accordance with the present invention either by direct collection of a sample from the inner wall of the lower Gl tract using a swab, brush or similar collecting device or by the lower rectal lavage or wash procedure as described above.
  • the detection of an analyte in the sample may be performed using a guaiac or other chromogen- based test for the detection of occult blood in the sample.
  • the detection of an analyte in a sample may be detection of occult blood (or other diagnostic antigens) in the sample by means of a chromatographic procedure, particularly by an immunochromatographic or other immunodiagnostic procedure which is well known in the art. Suitable immunochromatographic procedures are described, by way of example, in US Patent Nos. 5591645 and 5622871 , the disclosures of which are incorporated herein by reference.
  • detection of an analyte such as occult blood in the sample is carried out using a testing device and methods as disclosed in International Patent Application No. PCT/AU98/00830 (WO 99/18436), the contents of which are incorporated herein by reference.
  • Embodiments of the testing device disclosed in this International patent application are specifically disclosed for FOB testing, including guaiac testing, immunochromatographic testing, or a combination of both types of testing in a single testing device.
  • the direct method of collection of samples from the lower gastrointestinal tract in accordance with the present invention also enables collection of cells and cell debris, as well as free proteins, nucleic acids and their degradation products, all of which may be useful for analysis for indications of colorectal cancer or other pathologies.
  • cells and cell debris may be used for cytological examination in a manner similar to the use of Pap smears for identification of cervical cancer cells. While aberrant cells are frequently identified by microscopic examination by eye, significant progress continues to be made with computer assisted cytological image analysis. These technologies offer the potential for automated screening of large numbers of samples, without the risk of human error caused by fatigue, inattention, etc. The detection of aberrant cells may be further assisted if a stain or other identifier is used that specifically reacts with a cell-associated marker of pathology (protein/DNA/RNA, etc).
  • a sample is obtained intra-rectally from the lower Gl tract of a patient by the following procedure:
  • saline or water
  • a moulded tubular plastic fitting e.g. 50-80 mm long, 5-8 mm diameter
  • the fitting is designed to pass the liquid via many peripheral holes along its furthermost 25-40 mm (i.e. the tip end), so that the wash fluid is directed onto the inner walls of the Gl tract of the patient.
  • the wash fluid is then aspirated using the syringe to collect the fluid sample.
  • a filter material is located in the tubular fitting (e.g. Dacron windings, as used in the head of a swab), so that the withdrawn aspirate is filtered and reasonably clear. After withdrawal of the sample, the tubular fitting is discarded and the withdrawn aspirate removed from the syringe to be used for testing for occult blood.
  • FOB testing of the sample obtained by this procedure is conducted using a testing device as disclosed in International Patent Application No. PCT/AU98/00830 (WO 99/18436) configured to enable both a guaiac test and an immunochromatographic test for haemoglobin to be carried out on the same sample.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un procédé de prélèvement d'un échantillon chez un patient, notamment pour la détection du cancer colorectal ou d'autres états pathologiques ou maladies gastro-intestinaux. Le procédé consiste à prélever un échantillon directement de la lumière du tractus gastro-intestinal du patient.
PCT/AU2002/000419 2001-04-04 2002-04-02 Procédé de prélèvement d'un échantillon du tractus gastro-intestinal WO2002080775A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US28174101P 2001-04-04 2001-04-04
US60/281,741 2001-04-04

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WO2002080775A1 true WO2002080775A1 (fr) 2002-10-17

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7427505B2 (en) 2004-07-22 2008-09-23 Immunostics, Inc. Fecal occult blood testing device and method
CN101868729A (zh) * 2007-11-20 2010-10-20 霍夫曼-拉罗奇有限公司 利用标记物组合钙防卫蛋白和血红蛋白/触珠蛋白复合物从粪便样品评价结肠直肠癌的方法
US7833794B2 (en) 2004-07-22 2010-11-16 Immunostics, Inc. Fecal sampling device and method
US8304596B2 (en) 2008-04-11 2012-11-06 Immunostics, Inc. Fecal sampling device and method
US8679420B2 (en) 2004-07-22 2014-03-25 Immunostics, Inc. Fecal sampling device and method
US10244980B2 (en) 2015-08-24 2019-04-02 Hygieacare, Inc Large intestine contents' diagnosis and acoustic characterization
US10314863B2 (en) * 2015-08-24 2019-06-11 Hygieacare, Inc Apparatus for characterization of the contents of the large intestine and treatment of conditions of the large intestine
US11179421B2 (en) 2015-08-24 2021-11-23 Hygieacare, Inc. Reducing uncomfortable side effects of abdominal distension in patients treated in hydrocolonic preparation units

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2123856A1 (fr) * 1993-05-27 1994-11-28 Magne K. Fagerhol Test et trousse pour le diagnostic de maladies ou de troubles du systeme digestif
WO1998041153A1 (fr) * 1997-03-16 1998-09-24 A+ Science Invest Ab Dispositif et procede permettant de collecter dans le tractus gastro-intestinal d'un individu des echantillons gazeux representatifs d'une region qu'on utilise pour diagnostiquer une maladie gastro-intestinale
WO2001074251A2 (fr) * 2000-03-31 2001-10-11 Rita Medical Systems Inc. Appareil et procede de biopsie et traitement tissulaire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2123856A1 (fr) * 1993-05-27 1994-11-28 Magne K. Fagerhol Test et trousse pour le diagnostic de maladies ou de troubles du systeme digestif
WO1998041153A1 (fr) * 1997-03-16 1998-09-24 A+ Science Invest Ab Dispositif et procede permettant de collecter dans le tractus gastro-intestinal d'un individu des echantillons gazeux representatifs d'une region qu'on utilise pour diagnostiquer une maladie gastro-intestinale
WO2001074251A2 (fr) * 2000-03-31 2001-10-11 Rita Medical Systems Inc. Appareil et procede de biopsie et traitement tissulaire

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7427505B2 (en) 2004-07-22 2008-09-23 Immunostics, Inc. Fecal occult blood testing device and method
US7833794B2 (en) 2004-07-22 2010-11-16 Immunostics, Inc. Fecal sampling device and method
US8679420B2 (en) 2004-07-22 2014-03-25 Immunostics, Inc. Fecal sampling device and method
CN101868729A (zh) * 2007-11-20 2010-10-20 霍夫曼-拉罗奇有限公司 利用标记物组合钙防卫蛋白和血红蛋白/触珠蛋白复合物从粪便样品评价结肠直肠癌的方法
CN101868729B (zh) * 2007-11-20 2013-07-17 霍夫曼-拉罗奇有限公司 利用标记物组合钙防卫蛋白和血红蛋白/触珠蛋白复合物从粪便样品评价结肠直肠癌的方法
US8304596B2 (en) 2008-04-11 2012-11-06 Immunostics, Inc. Fecal sampling device and method
US10244980B2 (en) 2015-08-24 2019-04-02 Hygieacare, Inc Large intestine contents' diagnosis and acoustic characterization
US10314863B2 (en) * 2015-08-24 2019-06-11 Hygieacare, Inc Apparatus for characterization of the contents of the large intestine and treatment of conditions of the large intestine
US10835557B2 (en) 2015-08-24 2020-11-17 Hygieacare, Inc. Methods of image analysis of large intestine contents for diagnosis and treatment
US11179421B2 (en) 2015-08-24 2021-11-23 Hygieacare, Inc. Reducing uncomfortable side effects of abdominal distension in patients treated in hydrocolonic preparation units

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