WO1999009407A1 - Detecteur d'etats - Google Patents

Detecteur d'etats Download PDF

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Publication number
WO1999009407A1
WO1999009407A1 PCT/GB1998/002405 GB9802405W WO9909407A1 WO 1999009407 A1 WO1999009407 A1 WO 1999009407A1 GB 9802405 W GB9802405 W GB 9802405W WO 9909407 A1 WO9909407 A1 WO 9909407A1
Authority
WO
WIPO (PCT)
Prior art keywords
gas sensing
sensing device
gas
gaseous
patient
Prior art date
Application number
PCT/GB1998/002405
Other languages
English (en)
Inventor
Peter Alfred Payne
Krishna Chandra Persaud
Allan John Syms
Original Assignee
Osmetech Plc
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 Osmetech Plc filed Critical Osmetech Plc
Publication of WO1999009407A1 publication Critical patent/WO1999009407A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
    • G01N31/223—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating presence of specific gases or aerosols
    • 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
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/04—Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
    • G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators

Definitions

  • This invention relates to methods and apparatus for detecting the occurrence of conditions in a female patient, with particular, although by no means exclusive, reference to vaginal conditions such as cervical cancer.
  • Cervical cancer is a relatively common condition, and, accordingly, in the UK a great deal of effort has been spent in providing regular screening for the condition.
  • the existing tests are not always reliable and, furthermore, are rather intrusive and uncomortable for the patient. It would be desirable to provide a more accurate test. Furthermore, it would be desirable to provide a less intrusive test in which steps involving contact with the body could be easily performed by the patient herself.
  • the present invention addresses the aforementioned considerations, as well as providing methods and apparatus for the convenient detection of numerous conditions in a female patient.
  • a method for detecting the occurrence of a condition in a female patient comprising the steps of:
  • the sample may be obtained by applying sampling means to the vaginal region of the patient and transporting said sampling means to a gas sampling arrangement adapted to introduce gaseous or volatile substances emanating from said sampling means to said gas sensing device.
  • the sampling means may comprise a tampon, swab or means adapted to fit on the cervical cone.
  • the gas sensing device may be positioned in the vicinity of the vaginal region of the patient and said gaseous or volatile species sampled directly by the device.
  • the gas sensing device may be integrated into a pair of panties or the like, or into a tampon or the like.
  • the gas sensing device may comprise at least one semiconducting organic polymer gas sensor.
  • the gas sensing device may comprise an array of gas sensors.
  • the condition detected may be cervical cancer.
  • the condition detected may be ovarian or uterian cancer.
  • the condition detected may be a vital infection, which may comprise infection with human papilloma virus, cytomegalovirus, a sexually transmitted disease (STD) or human immuno deficiency virus (HIV).
  • a vital infection which may comprise infection with human papilloma virus, cytomegalovirus, a sexually transmitted disease (STD) or human immuno deficiency virus (HIV).
  • the condition detected may be associated with oestrus.
  • the condition detected may be a yeast infection, which may comprise infection with chlamydia.
  • a gas sensing system adapted to detect the occurrence of a condition in a female patient comprising:
  • sampling means for obtaining a sample of gaseous or volatile substances from the vaginal region of the patient and introducing said sample to said gas sensing device.
  • the gas sensing device may be adapted to be positioned in the vicinity of the vaginal region of the patient and to sample directly the gaseous or volatile species.
  • the gas sensing system may be integrated into a pair of panties or the like, or into a tampon or the like.
  • the gas sensing device may comprise at least one semiconducting organic polymer gas sensor.
  • the detection of gaseous or volatile species may be indicated by a variation in the colour of the semiconducting organic polymer or polymers.
  • the gas sensing device may comprise an array of gas sensors.
  • Figure 1 shows an apparatus for detecting the occurrence of a condition
  • FIG. 2 shows two embodiments of sampling means
  • Figure 3 shows a sparging device.
  • the invention provides a method for detecting the occurrence of a condition in a female patient comprising the steps of:
  • the test provided by the present invention has the advantage of being less intrusive, discomforting and embarrassing for the patient, since the patient herself can easily obtain the required sample.
  • many other conditions may be detected using the methods and apparatus of the present invention.
  • the detection of ovarian or uterian cancer, viral infections such as infection with human papilloma virus, cytomegalovirus, a STD or HIV, conditions associated with oestrus, and yeast infections such as infection with chlamydia are within the ambit of the present invention.
  • the detection of conditions associated with oestrus includes pregnancy testing and fertility monitoring.
  • bacterial infection such as bacterial vaginosis
  • International Publication WO 95/33848 discloses the detection of bacteria er se by monitoring characteristics gases or volatiles.
  • the present invention provides for the detection of non-bacterial conditions.
  • the sample is obtained by applying sampling means to the vaginal region of the patient and transporting the sampling means to a gas sampling arrangement adapted to introduce gaseous or volatile substances emanating from the sampling means to the gas sensing device.
  • the application of the sampling means can be performed by the patient herself, or by a medical practitioner (with minimal discomfort and inconvenience).
  • the sampling means may be sealed in a suitable gas- tight container for transportation to the gas sensing device, shown in Figure 1 , which might be situated, for example, in a pathology laboratory.
  • the sampling means 10 is introduced to a gas sampling arrangement 12.
  • gas sampling arrangements Numerous forms of gas sampling arrangements are known in the art - essentially, the purpose is to create a headspace of gases and vapours above the swab or tampon 10, and to transport the gases and vapours to the gas sensing device 14, usually entrained in a flow of an inert gas.
  • the output from the gas sensing device 14 is analysed by a computer 16, which also controls the overall operation of the device 14 and sampling arrangement 12.
  • the sampling means may comprise a tampon, a swab or means adapted to fit on the cervical cone, i.e. a variant on the so-called "cap”.
  • Figure 2a shows in cross section an embodiment of a tampon 20, having an outer layer 22 of a porous material, a semi-permeable membrane layer 24 (to exclude water) and a central pad 26 of an absorbent material.
  • Figure 2b shows an embodiment of a "cap” type sampling means 28 having an absorbent inner layer 30 and an impermeable outer layer 32.
  • the "cap” 28 is adapted to fit on the cervical cone 34 with minimal discomfort.
  • Figure 3 shows a portion of a gas sampling arrangement comprising a "sparging" device 36.
  • the sampling means 10 is disposed in the sparging device 36 and a carrier gas is flowed over the sampling means 10, thereby entraining gases and volatile species in the gas flow.
  • the carrier gas enters the sparging device 36 via an inlet port 38 and exits via an outlet port 40, thereafter being introduced to the gas sensing device.
  • a liquid or solution might be introduced to the sparging device 36 in order to assist in the extraction of volatile species or even to chemically modify certain species.
  • An example is treatment with an alkaline solution in order to produce the emission of amines.
  • a performed form of gas sensing device 14 comprises at least one semiconducting organic polymer (SOP) gas sensor.
  • SOP semiconducting organic polymer
  • suitable, gas sensitive, SOPs include heteroaromatic polymers such as polypyrrole, polyindole and various substituted variants.
  • the applicants produce commercially a range of gas sensing devices which utilise an array of SOPs. Further details concerning the choice of SOPs, their manufacture, methods for interrogating them and data analysis can be found, for example, Gardner J W and Bartlett P N, Sensors and Actuators B, 18-19 (1994) 211-220; Persaud K C, Bartlett J G and Pelosi P, in "Robots and Biological Systems : Towards a new bionics?”, Eds. Dario P, Sandini G and Aebisher P, NATO ASI Series F : Computers and Systems Sciences 102 (1993) 579 and references therein; International Publications WO 96/00383 and WO
  • an array of SOPs having broad and overlapping sensitivities is employed.
  • a single SOP gas sensor in conjunction with a suitable interrogation technique such as applying ac electrical signal to the sensor or a suitable time varying electrical signal accompanied by a time-to-frequency domain transformation (see International Publication WO 97/18467 and British Patent GB 2 203 553).
  • Neural network algorithms are commonly employed for data analysis purposes which, owing to the nature of the data, is usually a pattern recognition problem.
  • An advantage with neural networks is their flexibility. However, simplified data analysis methods may be applicable to devices which are specifically adapted to recognise the occurrence of a single condition.
  • the detection of a condition may be based on the intensities of the sensor responses as well as the patterns produced by them.
  • gas sensing device such as arrays of metal oxide semiconductor gas sensors, SAWS or quartz resonators, or combinations thereof, or forms of gas chromatography .
  • the gas sensing device is positioned in the vicinity of the vaginal region of the patient and the gaseous or volatile species are sampled directly by the device.
  • the gas sensing device may be integrated into a pair of panties or the like, in which instance the gas sensors would advantageously be incorporated in a gusset type arrangement.
  • the gas sensing device may be integrated into a tampon.
  • the tampon can be provided with a soft, gas permeable material, such as gauze, as an outer layer.
  • the gas sensor(s) and any associated sensor interrogation functions can be located in the main body of the tampon. SOP gas sensing devices are advantageous in this regard because sensors of relatively small physical dimensions can be readily produced.
  • These direct sampling embodiments may act purely as data storage devices, with data being downloaded subsequently onto a computer for analysis. Alternatively, they may be provided with means adapted to indicate that the presence of the condition has been detected.
  • One way of doing this is to employ semiconducting organic polymers that change colour on exposure to various gases (the colour change is associated with reduction and oxidation of the polymer - the same physical processes that affect conductivity). In this way, the presence or absence of a desired condition could be indicated by the colour of a gas sensor, or by a colour combination of an array of sensors.
  • the apparatus might incorporate other sensors, such as pH and temperature sensors, together with the gas sensing device. pH and temperature are important diagnostic conditions, and will probably affect the response of the gas sensing device itself and/or the nature of the species detected.
  • a confidential study detecting bacterial vaginosis was performed analysing vaginal swabs obtained from sixty eight women attending a genitourinary clinic. The patients were tested using standard clinical criteria for the occurrence of bacterial vaginosis. Additionally, a high vaginal swab was taken and placed directly into a sampling pouch which was sealed and sent for analysis. The pouch was unsealed and attached to a header which is part of a commercially available gas sensing device based on SOPs and manufactured by AromaScan pic, Crewe, Cheshire, UK. The pouch was inflated, detached from the header, conditioned at 37 °C for 30 minutes, and then attached to the sampling part of the AromaScan device for analysis. The headspace thus developed was pumped across the array of thirty two SOP sensors which comprise the active, gas sensing elements of the device.
  • the above described conditions might be detected from analysis of liquid samples obtained from the vaginal region of a patient. Analysis might employ analytical techniques such as GC- MS, LC or an antibody test such as an ELISA type test. Alternatively, a test might employ antibodies specific to certain diagnostic markers (such as proteins or peptides) which are coupled to an enzymatic moiety which permits amplification of the antibody- antigen interaction by releasing a specific volatile species which can be detected by a gas sensing device.
  • diagnostic markers such as proteins or peptides

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pathology (AREA)
  • Zoology (AREA)
  • General Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Dispersion Chemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Toxicology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

Le procédé décrit de détection d'un état particulier chez une patiente comprend les étapes suivantes: prélèvement d'un échantillon de substances gazeuses ou volatiles de la région vaginale de la patiente; détection de ces substances gazeuses ou volatiles au moyen d'un dispositif détecteur de gaz; et corrélation de la détection desdites substances gazeuses ou volatiles avec ledit état.
PCT/GB1998/002405 1997-08-14 1998-08-10 Detecteur d'etats WO1999009407A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9717209.2 1997-08-14
GBGB9717209.2A GB9717209D0 (en) 1997-08-14 1997-08-14 Condition detector

Publications (1)

Publication Number Publication Date
WO1999009407A1 true WO1999009407A1 (fr) 1999-02-25

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ID=10817459

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1998/002405 WO1999009407A1 (fr) 1997-08-14 1998-08-10 Detecteur d'etats

Country Status (2)

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GB (1) GB9717209D0 (fr)
WO (1) WO1999009407A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6013229A (en) * 1995-03-27 2000-01-11 California Institute Of Technology Sensor arrays for detecting analytes in fluids
WO2000054050A2 (fr) * 1999-03-09 2000-09-14 Osmetech Plc Procede pour detecter des desordres
US6190858B1 (en) * 1997-01-02 2001-02-20 Osmetech Plc Detection of conditions by analysis of gases or vapors
US6244096B1 (en) 1998-06-19 2001-06-12 California Institute Of Technology Trace level detection of analytes using artificial olfactometry
US6494833B1 (en) 2001-06-19 2002-12-17 Welch Allyn, Inc. Conditioning apparatus for a chemical sensing instrument
US7255677B2 (en) 2002-03-04 2007-08-14 Smiths Detection Inc. Detection, diagnosis, and monitoring of a medical condition or disease with artificial olfactometry
EP2096427A2 (fr) 1998-11-16 2009-09-02 California Institute of Technology Détermination simultanée de propriété d'équilibre et cinétique
WO2010099800A3 (fr) * 2009-03-02 2010-10-28 Asmaa Mohammed Shaaban Technologie de nez électronique pour machine à traire
WO2017178032A1 (fr) * 2015-04-22 2017-10-19 Lachlak Nassira Procedure de detection des infections ou maladies dans le domaine de la gynecologie a partir des composes organiques volatiles des exsudats vaginaux
WO2019072352A3 (fr) * 2017-10-09 2019-08-15 Lachlak Nassira Automate de détection des bactéries incriminées dans les infections ou maladies grâce à un système multi-capteurs intégrant une olfactométrie de reconnaissance des métabolites dégagés

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4010738A (en) * 1974-10-30 1977-03-08 The Trustees Of The University Of Pennsylvania Method of predicting and detecting ovulation
WO1983000742A1 (fr) * 1981-08-26 1983-03-03 Towsend, Marvin, S. Article jetable avec indicateur d'eau saline non-lessivable
WO1992001373A1 (fr) * 1990-07-16 1992-02-06 Diagnostic Markers, Inc. Detection tres rapide des infections d'origine fongique
WO1994004916A1 (fr) * 1992-08-14 1994-03-03 Cambridge Research & Innovation Limited Dispositif de detection d'amines volatiles
WO1995033848A1 (fr) * 1994-06-09 1995-12-14 Aromascan Plc Detection de bacteries
WO1996000384A1 (fr) * 1994-06-23 1996-01-04 Aromascan Plc Polymeres organiques semi-conducteurs

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4010738A (en) * 1974-10-30 1977-03-08 The Trustees Of The University Of Pennsylvania Method of predicting and detecting ovulation
WO1983000742A1 (fr) * 1981-08-26 1983-03-03 Towsend, Marvin, S. Article jetable avec indicateur d'eau saline non-lessivable
WO1992001373A1 (fr) * 1990-07-16 1992-02-06 Diagnostic Markers, Inc. Detection tres rapide des infections d'origine fongique
WO1994004916A1 (fr) * 1992-08-14 1994-03-03 Cambridge Research & Innovation Limited Dispositif de detection d'amines volatiles
WO1995033848A1 (fr) * 1994-06-09 1995-12-14 Aromascan Plc Detection de bacteries
WO1996000384A1 (fr) * 1994-06-23 1996-01-04 Aromascan Plc Polymeres organiques semi-conducteurs

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6013229A (en) * 1995-03-27 2000-01-11 California Institute Of Technology Sensor arrays for detecting analytes in fluids
US6190858B1 (en) * 1997-01-02 2001-02-20 Osmetech Plc Detection of conditions by analysis of gases or vapors
US6467333B2 (en) 1998-06-19 2002-10-22 California Institute Of Technology Trace level detection of analytes using artificial olfactometry
US6244096B1 (en) 1998-06-19 2001-06-12 California Institute Of Technology Trace level detection of analytes using artificial olfactometry
US6319724B1 (en) 1998-06-19 2001-11-20 Cyrano Sciences, Inc. Trace level detection of analytes using artificial olfactometry
US6841391B2 (en) 1998-06-19 2005-01-11 Smiths Detection-Pasadena, Inc. Medical applications of artificial olfactometry
EP2096427A2 (fr) 1998-11-16 2009-09-02 California Institute of Technology Détermination simultanée de propriété d'équilibre et cinétique
WO2000054050A3 (fr) * 1999-03-09 2001-01-25 Osmetech Plc Procede pour detecter des desordres
WO2000054050A2 (fr) * 1999-03-09 2000-09-14 Osmetech Plc Procede pour detecter des desordres
US6494833B1 (en) 2001-06-19 2002-12-17 Welch Allyn, Inc. Conditioning apparatus for a chemical sensing instrument
US7255677B2 (en) 2002-03-04 2007-08-14 Smiths Detection Inc. Detection, diagnosis, and monitoring of a medical condition or disease with artificial olfactometry
US7819803B2 (en) 2002-03-04 2010-10-26 Smiths Detection Inc. Detection, diagnosis, and monitoring of a medical condition or disease with artificial olfactometry
WO2010099800A3 (fr) * 2009-03-02 2010-10-28 Asmaa Mohammed Shaaban Technologie de nez électronique pour machine à traire
WO2017178032A1 (fr) * 2015-04-22 2017-10-19 Lachlak Nassira Procedure de detection des infections ou maladies dans le domaine de la gynecologie a partir des composes organiques volatiles des exsudats vaginaux
WO2019072352A3 (fr) * 2017-10-09 2019-08-15 Lachlak Nassira Automate de détection des bactéries incriminées dans les infections ou maladies grâce à un système multi-capteurs intégrant une olfactométrie de reconnaissance des métabolites dégagés

Also Published As

Publication number Publication date
GB9717209D0 (en) 1997-10-22

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