WO2008012566A2 - Dispositif, système et procédé de collecte de liquide - Google Patents

Dispositif, système et procédé de collecte de liquide Download PDF

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Publication number
WO2008012566A2
WO2008012566A2 PCT/GB2007/050389 GB2007050389W WO2008012566A2 WO 2008012566 A2 WO2008012566 A2 WO 2008012566A2 GB 2007050389 W GB2007050389 W GB 2007050389W WO 2008012566 A2 WO2008012566 A2 WO 2008012566A2
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
wick
pad
oral fluid
opening
Prior art date
Application number
PCT/GB2007/050389
Other languages
English (en)
Other versions
WO2008012566A3 (fr
Inventor
Ahmed Jehanli
Gordon Jowett
Original Assignee
Cozart Boiscience Limited
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 Cozart Boiscience Limited filed Critical Cozart Boiscience Limited
Publication of WO2008012566A2 publication Critical patent/WO2008012566A2/fr
Publication of WO2008012566A3 publication Critical patent/WO2008012566A3/fr

Links

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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/38—Swabs having a stick-type handle, e.g. cotton tips
    • 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
    • A61B2010/0003—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 including means for analysis by an unskilled person
    • A61B2010/0006—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 including means for analysis by an unskilled person involving a colour change

Definitions

  • the invention describes a method, device and system for collecting oral fluid for the purpose of detecting analytes in the fluid using for example point-of-care and laboratory-based tests.
  • oral fluid has been proposed as an alternative diagnostic matrix to blood and urine for the detection of analytes such as antibodies, antigens, hormones and pharmaceutical drugs including drugs of abuse (Choo and Huestis (2004) "Oral fluid as a diagnostic tool", Clinical Chemistry and Laboratory Medicine, volume 42, pages 1273-1287).
  • Oral fluid is easily accessible by non-invasive means, does not require experience in collection as is the case with blood, and can be easily collected under observation.
  • Oral fluid has been used successfully for therapeutic drug monitoring (methadone treatment of heroin addiction), detection of drugs of abuse in drug treatment clinics and work place, testing and detection of bacterial and viral infection, e.g., helico bacter and HIV.
  • Oral fluid can be used both for point-of-care and laboratory-based testing. It has been proposed as the matrix of choice for roadside testing for drugs of abuse, e.g. by the police.
  • the procedure for using oral fluid as a diagnostic matrix should involve a rapid collection phase (important for on-site testing), the collection of a sufficient volume for immediate and subsequent analysis, and the ability to extract the analyte under investigation from the oral fluid.
  • oral fluid is collected by placing some form of an absorbent material in the mouth followed by extraction of the oral fluid from the absorbent material, which can be made of cotton, cellulose, rayon or any other suitable material.
  • an absorbent material which can be made of cotton, cellulose, rayon or any other suitable material.
  • WO2006064285 describes an analyte collection apparatus that can be used for collecting oral fluid.
  • this device has no means of indicating that sufficient volume has been collected.
  • US patent 5260031 describes a saliva collection device with a volume adequacy indicator.
  • this device has the problem that it may take a relatively long time to collect an adequate volume of oral fluid.
  • the device requires the use of a serum filter (as described in US patent 5786227) to extract the oral fluid from the pad. This adds to the cost of the procedure and involves several time-consuming steps.
  • an oral fluid collection device comprising: an elongate shaft, the shaft being substantially hollow at one end and having an opening at that end; a pad of absorbent material attached to an outer surface of said shaft at or adjacent to said opening; and a wick located inside the hollow end of the shaft, said wick being at least partially coated or impregnated with a soluble dye for the purpose of providing a fluid adequacy indication during use, said pad and said wick being made of dissimilar materials.
  • Figure 1 shows a perspective view of an oral fluid collection device having a fluid adequacy indicator
  • Figure 1 a shows a perspective view of a wicking rod of the device of Figure 1 ;
  • Figures 2 and 2a illustrate first and second states of operation of the device of Figure l;
  • Figure 3 shows a perspective view of a fluid release widget of a collection tube
  • Figures 3a and 3b show perspective views of a collection tube in first and second use states
  • Figures 4a to 4c show cross-sectional views of a collection system in respective use states
  • Figure 5 shows a perspective view of a fluid collection device according to a second embodiment of the invention.
  • Figure 1 illustrates an oral fluid collection device comprising a hollow transparent polypropylene shaft/ handle or tube 2 with a cotton or rayon swab 3 spun onto a lower end 4 of the shaft.
  • the swab is shown transparent in the figure although in practice it will be opaque.
  • the weight of the cotton swab determines the volume of oral fluid to be collected, with about 0.07g allowing volumes of 0.3-0.4mL to be collected and about 0.2g allowing approximately 1.OmL to be collected.
  • a liquid-permeable wick or wicking rod 5 (Figure Ia) of chemically cross-linked polyester fibres (where the degree of crosslinking determines the porosity of the material) is inserted into the handle 2 through an upper open end and is pushed down through the handle until it is in contact with the swab 3.
  • the rod is made with a diameter to allow a snug fit into the handle.
  • the wicking rod 5 has a small amount of food dye (examples: Super Cook Blue or Green food colouring, Supercook, Sherburn-in-Elmet, Leeds, UK; Royal Blue food colouring, Sugerflair Colours Limited, Benfleet, Essex, England) 6 applied either as a line around the circumference of the rod or at the end of the rod that will be in contact with the swab.
  • the dye is allowed to dry prior to insertion of the rod into the handle. In both cases the dye is hidden by the swab and cannot be seen once the device is fully assembled (Figure 2).
  • An efficient manufacturing process for the device comprises first weaving the swab onto the shaft in situ.
  • a small amount of adhesive may first be applied to the shaft.
  • the adhesive is chosen to suit the intended purpose, i.e. it must be non-toxic and must not contaminate any test sample.
  • a glaze may be applied over the surface of the weaved swab to prevent disintegration of the swab in use.
  • the wicking rod is then inserted through the shaft, from the top end, until it reaches the swab end.
  • the dye may previously have been applied to the rod using, for example, a process similar to ink-jet printing.
  • the device is used by inserting the swab part in the mouth, wiping the gums, tongue and the inside of the cheeks.
  • the liquid eventually passes to the wicking rod, whereupon the dye is hydrated and moves up the wicking rod via the capillary action of the fluid.
  • the (now coloured) liquid wicks up the fibre rod, the colour appears from "inside" the swab head and is visible through the transparent walls of the polypropylene shaft/handle.
  • the movement of the coloured liquid to the end of the wicking rod is used as an indication that a sample of oral fluid has been successfully collected 5a ( Figure 2a).
  • wicking rod material with middle density middle porosity
  • this feature obviates the problem of users cheating the system by blowing air through the swab (in the case of a high porosity wicking rod, water vapour in the air may cause the dye to be hydrated and move sufficiently up the rod to indicate a positive result).
  • An insert or widget 8 ( Figure 3) is constructed from polypropylene or polystyrene material in the shape of a conical tube with external ridges 9 and feet 8a in such a way to allow it to fit snugly inside a collection tube 7 ( Figure 3a).
  • the collection tube contains an oral fluid extraction buffer solution 10.
  • the collector 1 is inserted inside the tube 7, the swab end is squeezed into the widget 8, causing the oral fluid to be released out from the swab into the buffer ( Figure 3b).
  • the tube can then be sealed with the collector inside, and sent to a laboratory for analysis.
  • the swab is held in place by the widget 8 which in turn, is held in the tube by the external ridges 9. This allows pouring of the buffer/oral fluid mixture into suitable containers that can then be sent to the laboratory for analysis.
  • Figures 4a-c are a cross-section cut illustration of this procedure.
  • the insert is shaped as a conical tube with the lower inside diameter being 1-2 mm less than the upper inside diameter. This configuration aids in the squeezing and compressing of the swab, resulting in a greater release of oral fluid from the swab.
  • the insert can even be made in a V- shape configuration to allow it to fit into V-shaped bottles or containers.
  • the ridges 9 are added to the structure to allow the insert to be held by friction inside the tube. Feet 8a and the intervening spaces allow circulation and mixing of the released oral fluid with the buffer solution.
  • the widget can be constructed with any other shape to fit into the required container. This may be a dropper bottle which would conveniently allow a test sample to be dropped onto, for example, a lateral flow test device.
  • FIG. 5 A modification of the device is illustrated in Figure 5.
  • the shaft/ handle 2 is scored around the circumference at a point 11 corresponding to the end of the wicking rod 5, thereby weakening the shaft at this point.
  • This allows the upper part of the handle to be snapped off after inserting the swab end into a suitable bottle or container with or without a widget.
  • the swab may be snapped into a dropper bottle containing an appropriate buffer to extract analyte from the swab and apply the mixture to a suitable on-site testing device like a lateral flow based test device.
  • This arrangement allows the collection device to be used even with relatively short containers.
  • Embodiments of the present invention have one or more of the following advantages:
  • the collection device allows easy and rapid collection of a sufficient volume of oral fluid. • The volume collected depends on the weight of the cotton material used in the swab and so can be easily varied depending upon the chosen application. By varying the porosity of the wicking rod, and removing the device from the moth when the fluid adequacy indicator indicates that collection is complete, it is equally possible to vary the collected volume up to the maximum capacity of the swab.
  • the wicking rod provides an indicator or proof of collecting a sample with a more defined volume.
  • the insert/widget serves to extract the oral fluid without the need to use centrifugation or filtration.
  • the collection device was constructed with 0.07g of cotton swab. Oral fluid was collected from drug-free volunteers using the device. Collection time and volume when the dye reached the end of the wicking rod were recorded. The results obtained (Table 1) showed that the device allowed rapid collection (average time: 36 seconds ) of fairly consistent volume of oral fluid (average volume: 0.35mL) which is ideal for on-site tests. The same experiment was repeated using a 0.2g swab (Table 2). The average collection time and volume were 55 seconds and about 1.OmL. This volume is more than sufficient for laboratory-based screening and confirmation analyses.
  • Drug recovery from the device was evaluated as follows: Oral fluid was collected by expectoration from a number of drug-free volunteers. The oral fluid was spiked with drugs (morphine, methadone, cannabis, temazepam, amphetamine, methamphetamine, ecstasy and cocaine at lOOng/mL each). 1 mL of the oral fluid was taken up by the device then processed as described in Figure 3. Drug concentration in the original oral fluid and the oral fluid recovered from the device was measured using enzyme immunoassay. Drug recovery for all the drugs was over 90%. It will be appreciated by the person of skill in the art that various modifications may be made to the above described embodiments without departing from the scope of the present invention.
  • Table 1 Oral fluid collection volume and time using 0.07g swab.
  • Table 2 Oral fluid collection volume and time using 0.2Og swab.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Absorbent Articles And Supports Therefor (AREA)

Abstract

L'invention concerne un dispositif de collecte de liquide oral comprenant une tige allongée (2), la tige étant sensiblement creuse à une extrémité (4) et présentant une ouverture au niveau de ladite extrémité. Un tampon de matière absorbante (3) est fixé sur une surface extérieure de ladite tige (2) au niveau de ladite ouverture ou de manière adjacente à celle-ci et une mèche (5) placée à l'intérieur de l'extrémité creuse de la tige. Ladite mèche (5) est au moins partiellement revêtue ou imprégnée d'un colorant soluble (6) dans le but de fournir une indication de suffisance de liquide lors de l'utilisation.
PCT/GB2007/050389 2006-07-25 2007-07-09 Dispositif, système et procédé de collecte de liquide WO2008012566A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0614740A GB2440353B (en) 2006-07-25 2006-07-25 Oral fluid collection device, system and method
GB0614740.9 2006-07-25

Publications (2)

Publication Number Publication Date
WO2008012566A2 true WO2008012566A2 (fr) 2008-01-31
WO2008012566A3 WO2008012566A3 (fr) 2008-11-06

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PCT/GB2007/050389 WO2008012566A2 (fr) 2006-07-25 2007-07-09 Dispositif, système et procédé de collecte de liquide

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Country Link
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WO (1) WO2008012566A2 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008139324A2 (fr) * 2007-05-11 2008-11-20 Inverness Medical Switzerland Gmbh Dispositif de recueil d'échantillons fluides
WO2010055460A1 (fr) * 2008-11-17 2010-05-20 Koninklijke Philips Electronics N.V. Dispositif de recueil d’un échantillon de fluide biologique
WO2010106061A1 (fr) 2009-03-18 2010-09-23 Cozart Bioscience Limited Dispositif de recueil de fluide oral
US7837939B2 (en) 2003-11-14 2010-11-23 Alere Switzerland Gmbh Rapid sample collection and analysis device and methods of use
US8071394B2 (en) 2006-07-26 2011-12-06 Alere Switzerland Gmbh Test device for detecting an analyte in a liquid sample
US8871155B2 (en) 2005-11-30 2014-10-28 Alere Switzerland Gmbh Devices for detecting analytes in fluid sample
JP2017516980A (ja) * 2014-04-17 2017-06-22 セクレタリー オブ ステート フォー ヘルスＳｅｃｒｅｔａｒｙ Ｏｆ Ｓｔａｔｅ Ｆｏｒ Ｈｅａｌｔｈ 流体採集デバイス
WO2017120783A1 (fr) * 2016-01-13 2017-07-20 The Procter & Gamble Company Ecouvillon d'échantillonnage buccal et utilisations associées
US10073069B2 (en) 2013-04-23 2018-09-11 Cordant Research Solutions, Llc Systems and methods to determine body drug concentration from an oral fluid

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102020133734A1 (de) 2020-12-16 2022-06-23 Drägerwerk AG & Co. KGaA Sammelvorrichtung für eine Probenahme, sowie Verfahren für eine Durchführung einer Probenahme von biologischem Material
DE102020133735A1 (de) 2020-12-16 2022-06-23 Dräger Safety AG & Co. KGaA Sammelvorrichtung für eine Probenahme, sowie Verfahren für eine Durchführung einer Probenahme von biologischem Material

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US4014322A (en) * 1975-10-23 1977-03-29 The Kendall Company Specimen collecting device and method
US5211182A (en) * 1991-10-23 1993-05-18 Deutsch Marshall E Home ovulation test kit and method
US5250412A (en) * 1987-03-23 1993-10-05 Diamedix Corporation Swab device and method for collecting and analyzing a sample
US5260031A (en) * 1990-12-18 1993-11-09 Saliva Diagnostic Systems, Inc. Saliva sampling device with sample adequacy indicating system
WO1995027205A1 (fr) * 1994-03-30 1995-10-12 Epitope, Inc. Dispositif et procede de dosage de la salive
EP0734685A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
DE19647545A1 (de) * 1996-11-16 1998-05-20 M & M Dental Medizin Gmbh Verwendung zum Bestimmen des Kariesrisikos und dazu besonders geeignete Testeinrichtung
US5981300A (en) * 1994-12-16 1999-11-09 M & M Dental-Medizin Gmbh Test kit for analyzing body fluids and analysis method
US20030064526A1 (en) * 2001-09-28 2003-04-03 Orasure Technologies, Inc. Sample collector and test device
EP1553394A1 (fr) * 2002-10-09 2005-07-13 Sunstar Inc. Outil de prelevement de crachat
WO2005082254A2 (fr) * 2004-02-23 2005-09-09 Ethicon, Inc. Dispositifs d'essais diagnostiques

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US5376337A (en) * 1990-12-18 1994-12-27 Seymour; Eugene H. Saliva sampling device and sample adequacy system
CA2121361C (fr) * 1991-11-27 1997-03-04 Jangbir S. Sangha Dispositif et methode de prelevement de salive et de dosage de drogues et d'anticorps anti-vih
US7374723B2 (en) * 2002-07-31 2008-05-20 Dräger Safety AG & Co. KGaA System for collecting and releasing saliva

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4014322A (en) * 1975-10-23 1977-03-29 The Kendall Company Specimen collecting device and method
US5250412A (en) * 1987-03-23 1993-10-05 Diamedix Corporation Swab device and method for collecting and analyzing a sample
US5260031A (en) * 1990-12-18 1993-11-09 Saliva Diagnostic Systems, Inc. Saliva sampling device with sample adequacy indicating system
US5211182A (en) * 1991-10-23 1993-05-18 Deutsch Marshall E Home ovulation test kit and method
WO1995027205A1 (fr) * 1994-03-30 1995-10-12 Epitope, Inc. Dispositif et procede de dosage de la salive
US5981300A (en) * 1994-12-16 1999-11-09 M & M Dental-Medizin Gmbh Test kit for analyzing body fluids and analysis method
EP0734685A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
DE19647545A1 (de) * 1996-11-16 1998-05-20 M & M Dental Medizin Gmbh Verwendung zum Bestimmen des Kariesrisikos und dazu besonders geeignete Testeinrichtung
US20030064526A1 (en) * 2001-09-28 2003-04-03 Orasure Technologies, Inc. Sample collector and test device
EP1553394A1 (fr) * 2002-10-09 2005-07-13 Sunstar Inc. Outil de prelevement de crachat
WO2005082254A2 (fr) * 2004-02-23 2005-09-09 Ethicon, Inc. Dispositifs d'essais diagnostiques

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7837939B2 (en) 2003-11-14 2010-11-23 Alere Switzerland Gmbh Rapid sample collection and analysis device and methods of use
US8871155B2 (en) 2005-11-30 2014-10-28 Alere Switzerland Gmbh Devices for detecting analytes in fluid sample
US8071394B2 (en) 2006-07-26 2011-12-06 Alere Switzerland Gmbh Test device for detecting an analyte in a liquid sample
WO2008139324A2 (fr) * 2007-05-11 2008-11-20 Inverness Medical Switzerland Gmbh Dispositif de recueil d'échantillons fluides
WO2008139324A3 (fr) * 2007-05-11 2009-06-04 Inverness Medical Switzerland Dispositif de recueil d'échantillons fluides
WO2010055460A1 (fr) * 2008-11-17 2010-05-20 Koninklijke Philips Electronics N.V. Dispositif de recueil d’un échantillon de fluide biologique
CN102216751A (zh) * 2008-11-17 2011-10-12 皇家飞利浦电子股份有限公司 用于采集生物学流体样本的装置
WO2010106061A1 (fr) 2009-03-18 2010-09-23 Cozart Bioscience Limited Dispositif de recueil de fluide oral
US10073069B2 (en) 2013-04-23 2018-09-11 Cordant Research Solutions, Llc Systems and methods to determine body drug concentration from an oral fluid
JP2017516980A (ja) * 2014-04-17 2017-06-22 セクレタリー オブ ステート フォー ヘルスＳｅｃｒｅｔａｒｙ Ｏｆ Ｓｔａｔｅ Ｆｏｒ Ｈｅａｌｔｈ 流体採集デバイス
WO2017120783A1 (fr) * 2016-01-13 2017-07-20 The Procter & Gamble Company Ecouvillon d'échantillonnage buccal et utilisations associées
CN107530062A (zh) * 2016-01-13 2018-01-02 宝洁公司 口腔取样拭子及其用途

Also Published As

Publication number Publication date
GB0614740D0 (en) 2006-09-06
GB2440353A (en) 2008-01-30
WO2008012566A3 (fr) 2008-11-06
GB2440353B (en) 2011-03-30

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