WO1994018892A1 - Dispositif de traitement de salive utilisee dans un dosage immunologique - Google Patents

Dispositif de traitement de salive utilisee dans un dosage immunologique Download PDF

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Publication number
WO1994018892A1
WO1994018892A1 PCT/IE1994/000007 IE9400007W WO9418892A1 WO 1994018892 A1 WO1994018892 A1 WO 1994018892A1 IE 9400007 W IE9400007 W IE 9400007W WO 9418892 A1 WO9418892 A1 WO 9418892A1
Authority
WO
WIPO (PCT)
Prior art keywords
saliva
receptacle
collected
absorbent pad
immunoassay
Prior art date
Application number
PCT/IE1994/000007
Other languages
English (en)
Inventor
Anthony Charles Nicholls
Stefan Gavojdea
Original Assignee
Trinity Research 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 Trinity Research Limited filed Critical Trinity Research Limited
Priority to AU60430/94A priority Critical patent/AU6043094A/en
Publication of WO1994018892A1 publication Critical patent/WO1994018892A1/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

Definitions

  • This invention relates to the collection and processing of saliva for use in an immunoassay. More particularly, the invention relates to a device for the processing of collected saliva for direct use in an immunoassay and additionally to means for collecting the saliva to be processed.
  • the oral immune system interacts actively with the immune system of the rest of the body. Within the oral cavity there is found a specific site of antigen-antibody response which involves extraoral lymph nodes and intraoral lymphoid aggregations.
  • saliva By saliva herein is included gingival liquid, hereinafter referred to collectively as saliva.
  • the intraoral lymphoid tissue comprises essentially four distinct tissue aggregations: the gingival lymphoid tissue; salivary gland lymphoid tissue; scattered sub-mucosal lymphoid aggregations; and the tonsils.
  • the salivary glands produce and secrete through their plasma cells predominantly IgA.
  • the IgA antibodies produced by the salivary glands are referred to as the secretory IgA and they represent the major immunoglobulin fraction contained in saliva.
  • saliva The presence of IgG and secretory IgA in the saliva prompted the use of saliva as a basis for immunological assays.
  • the suitability of saliva as a diagnostic body fluid has not been demonstrated for all diseases or even a significant proportion thereof.
  • Recent studies have demonstrated that saliva can be successfully used in testing for various conditions and diseases, including HIV antibody detection, rubella and hepatitis.
  • IgA antibodies are the major immunological fraction contained in saliva. In many instances, there are not enough specific IgA antibodies in saliva to perform a specific diagnostic test. Furthermore, the specific IgA may not be present in a sufficient amount to perform a test that compares favourably with a corresponding blood test. An example of the latter is the case of HIVl antibodies.
  • saliva contains about 0.01-0.1% of the immunoglobulins contained in the blood. Because of the reduced immunoglobulin content of saliva relative to blood, it is necessary to use more sensitive antigen-antibody assay methods relative to corresponding assays performed on the blood or blood fractions.
  • the collection of saliva is a relatively complicated procedure and can lead to misleading results when the saliva is collected from the salivary glands because of the relatively small volumes that can be collected and because of the viscosity and high mucous content of saliva.
  • Most of the methods currently employed involve collecting saliva through capillary tubes or suctioning saliva into micro-pipettes or syringes.
  • the use of saliva collected by these methods has inherent problems because of the high content of mucous and the limitations presented by the predominance of IgA, which is known not to be present in a sufficient amount in the case of certain specific antibodies.
  • saliva as a body fluid for diagnostic assays
  • the taking of saliva samples is non-invasive as compared with the taking of blood samples.
  • the collection of saliva for such assays can be carried out in situations where the availability of syringes might be limited or where strict hygiene practices might not be adhered to.
  • the invention provides a device for the processing of collected saliva for direct use in an immunoassay, comprising a receptacle for receiving an amount of saliva, said receptacle being inter-engageable with a filtration device at the free end thereof, such that inversion of the receptacle with the filtration device in position enables collected saliva to be filtered and the filtrate obtained to be directly used in an immunoassay for an immunoglobulin of interest.
  • the device according to the invention allows one to collect saliva from the oral cavity in sufficient amounts and in a form for direct use in an immunoassay, without a requirement for the usual laboratory instrumentation for the processing of the saliva once collected, as hereinafter described.
  • the invention also enables one to obtain a saliva sample suitable for use in an on the spot, rapid immunoassay with a minimum of sample manipulation following collection thereof.
  • the receptacle has a capacity of less than 10 ml, more especially 2-3 ml.
  • the filtration device comprises one or more layers of a filter material having a gradation of pore sizes in the range 0.5-5 ⁇ m.
  • the final layer through which the saliva percolates should have a pore size no greater than 1.0 ⁇ m.
  • Suitable materials for use in the filtration device include layers of glass, ceramic, wood, paper, etc., more especially glass.
  • the filtration device preferably has an integral dropper mechanism, so that the filtrate can be transferred in droplets of a predetermined size, when desired.
  • the saliva is collected by means of an absorbent pad wiped over a surface in the oral cavity, said absorbent pad being formed of a material which has a low binding capacity for immunoglobulins, and said absorbent pad being receivable in the receptacle of the device.
  • the walls of the receptacle are preferably flexible, whereby the application of pressure to said walls facilitates release of immunoglobulins from the absorbent pad by causing agitation of a liquid medium contained in the device.
  • the flexible receptacle is preferably formed of a flexible plastics material.
  • the receptacle has a tubular shape approximately 30 mm in length and with a diameter of approximately 15 mm.
  • the receptacle is also suitably provided with a cap or other closing means.
  • the absorbent pad when such is used to collect saliva is preferably mounted at the end of a handle to facilitate the collection of saliva and the transfer thereof, once collected, to the receptacle.
  • the absorbent pad and associated handle can resemble a device commonly used in the home and referred to as a cotton bud or tip or as sold under the Trade Mark Q-TIP.
  • the absorbent pad can be of any suitable shape which permits the collection of saliva, when the pad is wiped over a surface in the oral cavity such as the gums or under the tongue for approximately 2 minutes. At the end of the collection period, the saliva impregnated pad is removed from the mouth and transferred to the receptacle for processing of the saliva.
  • the absorbent pad is suitably made of cotton, paper, rayon, or sponge or other material which has a low binding capacity for immunoglobulins.
  • An especially suitable material is rayon.
  • rayon material for the absorbent pad eliminates a common problem observed with immunoglobulins which is non-specific binding.
  • a rayon absorbent pad or other material with a very low binding capacity for immunoglobulins obviates the need for the addition of agents to the absorbent material to prevent non-specific binding, which agents can cause problems for the patient when the saliva collection pad is inserted in the oral cavity. Furthermore, the use of such agents can lead to problems as regards obtaining regulatory approval for a saliva collection device.
  • rayon material has a high absorption capacity, allowing the collection of 0.1-1.1 ml of saliva, when used to collect saliva as hereinbefore described.
  • the absorbent pad is suitably 10-30 mm in length and 5- 15 mm in diameter.
  • the handle suitably has a length of 60-100 mm and a diameter of 1-3 mm.
  • the handle is preferably provided with a weakened line adjacent the absorbent pad which facilitates detachment of the handle once the absorbent pad has been inserted in the receptacle for processing of the collected saliva.
  • the handle is broken at the weakened line through a snapping action. More specifically, the absorbent pad is inserted into the receptacle until the weakened line of the handle lines up with the top edge of the receptacle, the top edge providing resistance for said handle. Once the handle is detached, leaving the pad inside the receptacle, the handle is discarded.
  • an absorbent pad When an absorbent pad is used to collect saliva, an amount of a suitable buffer, such as phosphate buffered saline (PBS) at pH 7.2, is inserted in the receptacle, such that once the absorbent pad is inserted in the receptacle, the buffer will saturate said pad, releasing antibodies therefrom. By squeezing the receptacle several times, the antibodies will equilibrate between the respective phases.
  • PBS phosphate buffered saline
  • the receptacle contains approximately 0.75 ml of PBS.
  • the receptacle is inverted with the filtration device mounted at the free end and immunoglobulin material, free of mucous, tissue and food debris resulting from the filtration process is obtained in a form ready to use in an immunoassay.
  • the dropper mechanism when used in association with the filtration device suitably provides drops of processed liquid of approximately 30-50 ⁇ l.
  • a rinse solution may be used.
  • a suitable rinse solution is PBS at a pH of 7.2.
  • the solution is expelled by the patient into a container from which the PBS was administered.
  • Approximately 2 ml of the collected solution is transferred into the receptacle in accordance with the invention.
  • the walls of the receptacle are preferably flexible.
  • the collected salivary material is filtered through the filtration device in the same manner as material released from the absorbent pad.
  • the receptacle is inverted to allow the collected material to percolate through the filtration device for the removal of mucous, tissue and food debris, to provide a sample or specimen which can be immediately used in an immunoassay.
  • the filtration of collected saliva in accordance with the invention provides a sample which is free of entrained mucous, tissue and food debris, which can be used without any further manipulation.
  • Fig. 1 is an exploded schematic representation of a device according to the invention for the processing of collected saliva
  • Fig. 2 is a schematic representation of a saliva collection device for use with the device of Fig. 1.
  • the device 10 comprises a tubular receptacle 1 1 , 30 mm long and 15 mm in diameter and made of a flexible plastics material.
  • the receptacle 1 1 receives at its open end 12, a filtration device 13 with an integral dropper mechanism 14.
  • the filtration device 13 can be inter-engageable with the receptacle 1 1 in known manner and in such a way that the device is sealed against any egress of the sample when the device 10 is in an inverted mode, other than through the filtration device 13 and the associated dropper mechanism 14.
  • the filtration device 13 in the engaged position abuts an internal rib 15 provided on the receptacle 11.
  • a saliva collection device having an absorbent pad 17 of rayon material mounted on a plastics handle 18.
  • the absorbent pad 17 is 15 mm long and 10 mm in diameter.
  • the handle 18 is 60 mm long and is provided with a weakened line 19 adjacent the absorbent pad 17.
  • the device 16 is used to collect a sample of saliva on the absorbent pad 17 from the oral cavity of a patient as hereinabove described.
  • the device 16 is used to transfer a collected sample to the device 10 which contains an amount of a buffer such as PBS, suitably 0.75 ml, at pH 7.2.
  • the device 16 is inserted into the receptacle 11 to an extent such that the weakened line 19 is adjacent the upper edge thereof, whereupon the handle 18 is broken off by a snapping action and discarded.
  • the filtration device 13 and integral dropper mechanism 14 is attached to the device 10 and the walls of the device 10 are squeezed so as to facilitate release of bound antibody into the PBS buffer.
  • the device 10 is then inverted, whereupon the contents of the device percolate through filtration device 13, assisted by further squeezing of the tubular body 1 1.
  • the filtration device 13 has a number of layers of a filter material (not shown) as hereinabove described with graded pore sizes which retain mucous, tissue and food debris contained in saliva while permitting immunoglobulins to pass therethrough into the dropper mechanism 14 for collection. Droplets of filtrate are collected from the dropper mechanism 14 for use in an immunoassay.
  • Saliva was collected using a device 16 of the type illustrated in Fig. 2 and the saliva processed using a device 10 of the type depicted in Fig. 1.
  • the SalivaCard (Trade Mark) assay is a modified version of the SeroCard (Trade Mark) assay - marketed in Canada and the U.S.A. by Disease Detection International, Inc., Irvine, California, U.S.A. and manufactured and marketed in countries other than Canada and the U.S.A. by Trinity Biotech pic - modified to run on saliva instead of serum.
  • the collection and processing of saliva in accordance with the invention is an effective method for providing samples by a non-invasive method for use in immunoassay.
  • the device according to the invention has particular application in poorer areas of the world, such as Third World countries, where access to laboratory instrumentation may not be a reality.
  • the device according to the invention has particular application for the testing of patients for AIDS and thus its advantages are clear as regards Third World countries such as countries in the African Continent where AIDS is pandemic, but also for on the spot checking at frontiers.

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

Abstract

Dispositif (10) de traitement de salive prélevée en vue d'une utilisation directe dans un dosage immunologique. De préférence, le dispositif (10) comporte un récipient (11) à parois souples destiné à recevoir une certaine quantité de salive. Le récipient (11) peut coopérer avec un dispositif filtrant (13) possédant un mécanisme compte-gouttes intégré (14). Le dispositif filtrant (13) possède un certain nombre de couches en matière filtrante dont les pores présentent des dimensions graduées de manière à permettre le passage d'immunoglobulines tout en interdisant celui des débris de muqueuse, de tissu et d'aliments présents dans la salive. On peut utiliser un embout absorbant (17) monté sur une tige (18) pour prélever la salive et la transférer au récipient (11), puis on détache la tige (18) en la brisant au niveau d'une ligne d'affaiblissement (19). On peut serrer le récipient (11) afin de faciliter la libération des immunoglobulines dans un tampon, puis on retourne le dispositif (10) afin de permettre le filtrage de la salive.
PCT/IE1994/000007 1993-02-23 1994-02-21 Dispositif de traitement de salive utilisee dans un dosage immunologique WO1994018892A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU60430/94A AU6043094A (en) 1993-02-23 1994-02-21 Device for the processing of saliva for use in an immunoassay

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IES930129 1993-02-23
IES930129 IES58662B2 (en) 1993-02-23 1993-02-23 Device for the processing of saliva for use in an immunoassay

Publications (1)

Publication Number Publication Date
WO1994018892A1 true WO1994018892A1 (fr) 1994-09-01

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PCT/IE1994/000007 WO1994018892A1 (fr) 1993-02-23 1994-02-21 Dispositif de traitement de salive utilisee dans un dosage immunologique

Country Status (3)

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AU (1) AU6043094A (fr)
IE (1) IES58662B2 (fr)
WO (1) WO1994018892A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6022326A (en) * 1998-10-30 2000-02-08 Lifepoint, Inc. Device and method for automatic collection of whole saliva
EP1271124A1 (fr) * 2001-06-21 2003-01-02 GC Corporation Instrument et méthode pour le prétraitement de salive
WO2006031758A2 (fr) * 2004-09-10 2006-03-23 Pronovost Allan D Controle du glucose salivaire
US7114403B2 (en) 2003-05-30 2006-10-03 Oakville Hong Kong Co., Ltd Fluid collection and application device and methods of use of same
US7544324B2 (en) 2003-11-14 2009-06-09 Oakville Hong Kong Company Limited Rapid sample analysis storage devices 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
CN107735665A (zh) * 2015-06-08 2018-02-23 勃林格殷格翰维特梅迪卡有限公司 用于获得唾液样品的方法和收集装置
US10073069B2 (en) 2013-04-23 2018-09-11 Cordant Research Solutions, Llc Systems and methods to determine body drug concentration from an oral fluid

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3692493A (en) * 1970-09-22 1972-09-19 Us Health Education & Welfare Lymphocyte transport bag
US4014653A (en) * 1974-12-26 1977-03-29 Denver Chemical Manufacturing Company Micro-filter
BE849898A (fr) * 1976-12-28 1977-06-28 Dispositif de dilution et de filtration
EP0056241A1 (fr) * 1981-01-12 1982-07-21 MetPath, Inc. Appareil pour le prélèvement de salive
US4618576A (en) * 1984-02-27 1986-10-21 Becton Dickinson And Company Diagnostic test for Streptococcus A
EP0354704A1 (fr) * 1988-08-01 1990-02-14 Adi Diagnostics Inc. Dispositif de tampon médical
EP0418739A1 (fr) * 1989-09-21 1991-03-27 Epitope, Inc. Captage d'immunoglobulines orales pour l'immunoessai
EP0520408A2 (fr) * 1991-06-25 1992-12-30 Saliva Diagnostic Systems, Inc. Dispositif d'échantillonnage et système d'adéquation d'échantillon

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3692493A (en) * 1970-09-22 1972-09-19 Us Health Education & Welfare Lymphocyte transport bag
US4014653A (en) * 1974-12-26 1977-03-29 Denver Chemical Manufacturing Company Micro-filter
BE849898A (fr) * 1976-12-28 1977-06-28 Dispositif de dilution et de filtration
EP0056241A1 (fr) * 1981-01-12 1982-07-21 MetPath, Inc. Appareil pour le prélèvement de salive
US4618576A (en) * 1984-02-27 1986-10-21 Becton Dickinson And Company Diagnostic test for Streptococcus A
EP0354704A1 (fr) * 1988-08-01 1990-02-14 Adi Diagnostics Inc. Dispositif de tampon médical
EP0418739A1 (fr) * 1989-09-21 1991-03-27 Epitope, Inc. Captage d'immunoglobulines orales pour l'immunoessai
EP0520408A2 (fr) * 1991-06-25 1992-12-30 Saliva Diagnostic Systems, Inc. Dispositif d'échantillonnage et système d'adéquation d'échantillon

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6022326A (en) * 1998-10-30 2000-02-08 Lifepoint, Inc. Device and method for automatic collection of whole saliva
EP1271124A1 (fr) * 2001-06-21 2003-01-02 GC Corporation Instrument et méthode pour le prétraitement de salive
JP2003004605A (ja) * 2001-06-21 2003-01-08 Gc Corp 唾液の前処理用具及び唾液の前処理方法
AU782324B2 (en) * 2001-06-21 2005-07-21 Gc Corporation Pretreatment instrument of saliva and pretreatment method of saliva
JP4642277B2 (ja) * 2001-06-21 2011-03-02 株式会社ジーシー 唾液の前処理用具及び唾液の前処理方法
US7160689B2 (en) 2001-06-21 2007-01-09 Gc Corporation Pretreatment instrument of saliva and pretreatment method of saliva
US7114403B2 (en) 2003-05-30 2006-10-03 Oakville Hong Kong Co., Ltd Fluid collection and application device and methods of use of same
US7837939B2 (en) 2003-11-14 2010-11-23 Alere Switzerland Gmbh Rapid sample collection and analysis device and methods of use
US7544324B2 (en) 2003-11-14 2009-06-09 Oakville Hong Kong Company Limited Rapid sample analysis storage devices and methods of use
WO2006031758A2 (fr) * 2004-09-10 2006-03-23 Pronovost Allan D Controle du glucose salivaire
WO2006031758A3 (fr) * 2004-09-10 2006-12-21 Allan D Pronovost Controle du glucose salivaire
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
US10073069B2 (en) 2013-04-23 2018-09-11 Cordant Research Solutions, Llc Systems and methods to determine body drug concentration from an oral fluid
CN107735665A (zh) * 2015-06-08 2018-02-23 勃林格殷格翰维特梅迪卡有限公司 用于获得唾液样品的方法和收集装置
CN107735665B (zh) * 2015-06-08 2021-12-10 勃林格殷格翰维特梅迪卡有限公司 用于获得唾液样品的方法和收集装置

Also Published As

Publication number Publication date
IES930129A2 (en) 1993-11-03
IES58662B2 (en) 1993-11-03
AU6043094A (en) 1994-09-14

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