WO1998027196A1 - Sample-collecting and assay device - Google Patents
Sample-collecting and assay device Download PDFInfo
- Publication number
- WO1998027196A1 WO1998027196A1 PCT/GB1997/003458 GB9703458W WO9827196A1 WO 1998027196 A1 WO1998027196 A1 WO 1998027196A1 GB 9703458 W GB9703458 W GB 9703458W WO 9827196 A1 WO9827196 A1 WO 9827196A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- bottom part
- top part
- liquid
- ruptured
- Prior art date
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N2001/028—Sampling from a surface, swabbing, vaporising
Definitions
- This invention relates to a sample-collecting and assay device, and in particular to a simple hygiene monitor. Background of the Invention
- WO-A-9425619 describes reactions where metabolites such as ATP can be amplified and detected, e.g. colorimetrically. Application of this chemistry is of value in dirt monitoring or in the detection of microorganisms on a surface that are collected by swabbing.
- WO-A-9525948 discloses a sample-collecting and assay device comprising a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part. There may be one or more foil-sealed bottom parts fixed within the tube, and the foils are successively broken by movement of the swab, or a coaxially-extending blade-like member, through the tube.
- WO-A-9703209 discloses a similar device, in which reagent is contained in a bottom part with a window, and which has a seal broken by movement of the swab through the tube. Another similar device is disclosed in WO-A-9723596. Summary of the nvention
- An assay device is for use in determining the presence in a liquid sample of a target component that, in combination with other components, undergoes a reaction to give a detectable signal.
- the novel device comprises a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part, the top part includes a compartment containing liquid and partly defined by a first frangible membrane that can be ruptured to release the liquid into the tube, and the bottom part contains a reagent and is partly defined by a second frangible membrane that can be ruptured on movement of the bottom part relative to the tube.
- the novel device shares many characteristics with the prior art devices, described above, its particular advantages include the use of a syringe-like mechanism within the top dispenser, to ensure repeatable and reproducible dispensing of liquid reagent.
- the top part may be unitary or comprise a separate component containing reagent, the design of the top reagent container and its holder may be such that a single operation, depressing the container, ruptures the seal and evacuates the contents of the container down the swab shaft, ensuring accurate and reproducible dispensing of the liquid reagent with minimal dead volume and without introduction of any air, unlike a "pumping" dispensing system. Description of the nvention
- a device of this invention is particularly suitable for determining the presence of microorganisms, in which case the target component is ATP.
- the target component is ATP.
- the invention will now be described by way of example only with reference to this embodiment. Further, again for the purpose of illustration, the invention will be described with reference to reactions of the type described in WO-A-9425619, i.e. involving enzymes and their substrates. These materials constitute the components that, in combination, undergo the reaction that gives the detectable signal.
- Such a reaction includes the following: AMP + ATP - ADP
- G glucose
- G6P glucose-6-phosphate.
- Glucose is then converted to give a colour, in a further enzymatic sequence, e.g. utilising glucose oxidase (GO) and horseradish peroxidase (HRP).
- GO glucose oxidase
- HRP horseradish peroxidase
- the analyte may be detected by bioluminescence. Suitable reagents etc. are described in WO-A-9525428.
- the reaction components may be present together in the bottom part, in a freeze- dried mixture.
- a sample e.g. of microorganisms obtained by swabbing
- the reagents and liquid are mixed with them.
- the reaction generates a colour, comparison of that and a standard can be made readily, to give a quick indication of the concentration of the analyte in the sample.
- Figure 1 A shows separate side views of a device embodying the invention
- Figure IB is a cross-section of the same embodiment, along the line A-A in Fig. 1 A
- Figure 2 is an exploded view of the embodiment shown in Fig. 1.
- the embodiment illustrated there comprises a tube 1 with a pen-type holder 2.
- a top part 3 and a bottom part 4 are each mounted on the tube and each can be pushed into close engagement with the tube. In the case of the top part, close engagement is prevented, until required, by the removable or peelable safety seal 5.
- the top part 3 has mounted thereon a tubular elongate member 6 that terminates in a swab 7.
- the top part 3 also comprises a separate component 8 which is a compartment having a foil seal 9. On depression of this component, the foil seal is ruptured, and a known amount of liquid is discharged down the elongate member to the swab 7, within the tube 1.
- the bottom part 4 is in the form of a foil-sealed cuvette including a window 10. It may contain freeze-dried reagent(s).
- the foil is broken by pushing the part 4 inwardly with respect to the tube 1.
- the foil may be broken on the swab or on an angled blade- like member 1 1 provided as an internal component of the tube 1.
- the top part 3 is removed from the tube 1, a sample is taken up on the swab 7, and this is replaced in the tube.
- the seal on the bottom part 4 is then broken.
- the safety seal 5 is then removed, and the component 8 pushed inwards, to release a known quantity of liquid. Results can be read through the window 10.
- a qualitative assessment can be made by comparison of the colour generated with reference spots of different colour intensity (of which 3 are shown in Fig. 1A).
Abstract
An assay device comprises a tube (1), a removable top part (3) and a bottom part (4), wherein an elongate member (6) with a swab (7) at its distal end is mounted on the top part, the top part includes a compartment (8) containing liquid and partly defined by a first frangible membrane (9) that can be ruptured to release the liquid into the tube, and the bottom part contains a reagent and is partly defined by a second frangible membrane that can be ruptured on movement of the bottom part relative to the tube. Reaction occurring in the bottom part can be observed through a window (10).
Description
SAMPLE-COLLECTING AND ASSAY DEVICE Field of the nvention
This invention relates to a sample-collecting and assay device, and in particular to a simple hygiene monitor. Background of the Invention
WO-A-9425619 describes reactions where metabolites such as ATP can be amplified and detected, e.g. colorimetrically. Application of this chemistry is of value in dirt monitoring or in the detection of microorganisms on a surface that are collected by swabbing. WO-A-9525948 discloses a sample-collecting and assay device comprising a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part. There may be one or more foil-sealed bottom parts fixed within the tube, and the foils are successively broken by movement of the swab, or a coaxially-extending blade-like member, through the tube. WO-A-9703209 discloses a similar device, in which reagent is contained in a bottom part with a window, and which has a seal broken by movement of the swab through the tube. Another similar device is disclosed in WO-A-9723596. Summary of the nvention
An assay device according to the present invention is for use in determining the presence in a liquid sample of a target component that, in combination with other components, undergoes a reaction to give a detectable signal. The novel device comprises a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part, the top part includes a compartment containing liquid and partly defined by a first frangible membrane that can be ruptured to release the liquid into the tube, and the bottom part contains a reagent and is partly defined by a second frangible membrane that can be ruptured on movement of the bottom part relative to the tube.
By means of the invention, direct analysis can be made, by observing the signal generated, in the bottom part. Although the novel device shares many characteristics with the prior art devices, described above, its particular advantages include the use of a syringe-like mechanism within the top dispenser, to ensure repeatable and reproducible dispensing of liquid reagent. Although the top part may be unitary or comprise a
separate component containing reagent, the design of the top reagent container and its holder may be such that a single operation, depressing the container, ruptures the seal and evacuates the contents of the container down the swab shaft, ensuring accurate and reproducible dispensing of the liquid reagent with minimal dead volume and without introduction of any air, unlike a "pumping" dispensing system. Description of the nvention
A device of this invention is particularly suitable for determining the presence of microorganisms, in which case the target component is ATP. The invention will now be described by way of example only with reference to this embodiment. Further, again for the purpose of illustration, the invention will be described with reference to reactions of the type described in WO-A-9425619, i.e. involving enzymes and their substrates. These materials constitute the components that, in combination, undergo the reaction that gives the detectable signal. Such a reaction includes the following: AMP + ATP - ADP
ADP + G6P - ATP + G wherein G is glucose and G6P is glucose-6-phosphate. These reactions are catalysed by adenylate kinase and glucokinase. Glucose is then converted to give a colour, in a further enzymatic sequence, e.g. utilising glucose oxidase (GO) and horseradish peroxidase (HRP).
Alternatively, the analyte may be detected by bioluminescence. Suitable reagents etc. are described in WO-A-9525428.
The reaction components may be present together in the bottom part, in a freeze- dried mixture. In use of a device of the invention, a sample, e.g. of microorganisms obtained by swabbing, is provided and the reagents and liquid are mixed with them. Especially if the reaction generates a colour, comparison of that and a standard can be made readily, to give a quick indication of the concentration of the analyte in the sample.
The invention will now be described by way of example only with reference to the accompanying drawings, in which:
Figure 1 A shows separate side views of a device embodying the invention, and Figure IB is a cross-section of the same embodiment, along the line A-A in Fig. 1 A; and
Figure 2 is an exploded view of the embodiment shown in Fig. 1.
For simplicity, a device of the invention will be described with reference to Fig.
IB. The embodiment illustrated there comprises a tube 1 with a pen-type holder 2. A top part 3 and a bottom part 4 are each mounted on the tube and each can be pushed into close engagement with the tube. In the case of the top part, close engagement is prevented, until required, by the removable or peelable safety seal 5.
The top part 3 has mounted thereon a tubular elongate member 6 that terminates in a swab 7. The top part 3 also comprises a separate component 8 which is a compartment having a foil seal 9. On depression of this component, the foil seal is ruptured, and a known amount of liquid is discharged down the elongate member to the swab 7, within the tube 1.
The bottom part 4 is in the form of a foil-sealed cuvette including a window 10. It may contain freeze-dried reagent(s). The foil is broken by pushing the part 4 inwardly with respect to the tube 1. The foil may be broken on the swab or on an angled blade- like member 1 1 provided as an internal component of the tube 1.
In use, the top part 3 is removed from the tube 1, a sample is taken up on the swab 7, and this is replaced in the tube. The seal on the bottom part 4 is then broken. The safety seal 5 is then removed, and the component 8 pushed inwards, to release a known quantity of liquid. Results can be read through the window 10. A qualitative assessment can be made by comparison of the colour generated with reference spots of different colour intensity (of which 3 are shown in Fig. 1A).
Claims
1. An assay device comprising a tube, a removable top part and a bottom part, wherein an elongate member with a swab at its distal end is mounted on the top part, the top part includes a compartment containing liquid and partly defined by a first frangible membrane that can be ruptured to release the liquid into the tube, and the bottom part contains a reagent and is partly defined by a second frangible membrane that can be ruptured on movement of the bottom part relative to the tube.
2. A device according to claim 1, wherein the top part includes the compartment for liquid as a separate component thereof.
3. A device according to claim 1 or claim 2, wherein the elongate member is tubular.
4. A device according to claim 3, wherein liquid released from the top part is adapted to pass through the elongate member.
5. A device according to any preceding claim, which comprises a blade-like member adapted to break the second membrane.
6. A device according to any preceding claim, wherein the bottom part comprises a window, for observation of a reaction therewithin.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU77385/98A AU7738598A (en) | 1996-12-16 | 1997-12-16 | Sample-collecting and assay device |
PCT/GB1998/003669 WO1999031218A1 (en) | 1997-12-16 | 1998-12-10 | Sample-collecting and assay device |
AU15692/99A AU1569299A (en) | 1997-12-16 | 1998-12-10 | Sample-collecting and assay device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9626101.1A GB9626101D0 (en) | 1996-12-16 | 1996-12-16 | Assay device |
GB9626101.1 | 1996-12-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998027196A1 true WO1998027196A1 (en) | 1998-06-25 |
Family
ID=10804526
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1997/003458 WO1998027196A1 (en) | 1996-12-16 | 1997-12-16 | Sample-collecting and assay device |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU7738598A (en) |
GB (1) | GB9626101D0 (en) |
WO (1) | WO1998027196A1 (en) |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999031218A1 (en) * | 1997-12-16 | 1999-06-24 | Celsis International Plc | Sample-collecting and assay device |
WO2002055730A2 (en) * | 2001-01-11 | 2002-07-18 | Hygiena Llc | Hygiene monitoring |
US6653147B2 (en) | 2000-03-31 | 2003-11-25 | Neogen Corporation | Apparatus and method for chemiluminescent assays |
WO2005068969A1 (en) * | 2003-12-23 | 2005-07-28 | Kimberly-Clark Worldwide, Inc. | Self-contained swab-based diagnostic systems |
US6927851B2 (en) | 2000-03-31 | 2005-08-09 | Neogen Corporation | Methods and apparatus to improve the sensitivity and reproducibility of bioluminescent analytical methods |
GB2422663A (en) * | 2005-01-27 | 2006-08-02 | Martyn Johnson-Townley | Device for surface assay |
US7229783B2 (en) | 2000-08-01 | 2007-06-12 | Charm Sciences, Inc. | Method for monitoring hygiene |
EP1848999A2 (en) * | 2005-02-16 | 2007-10-31 | Ping Epitope Diagnostics Gao | Fecal sample test device and methods of use |
WO2010129727A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Coated substrates comprising a cell extractant and biodetection methods thereof |
WO2010129726A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Articles with matrix comprising a cell extractant and biodetection methods thereof |
US7863053B2 (en) | 2003-12-23 | 2011-01-04 | Kimberly-Clark Worldwide, Inc. | Swab-based diagnostic systems |
DE102013014901A1 (en) * | 2013-09-06 | 2015-03-12 | Testo Ag | Method for testing a sample for microorganisms and / or viruses and corresponding swabs |
US20200278368A1 (en) * | 2017-09-27 | 2020-09-03 | Axxin Pty Ltd | Diagnostic test system and method |
WO2023034995A1 (en) * | 2021-09-06 | 2023-03-09 | Becton, Dickinson And Company | Method of piercing seal for sample testing |
US11634758B2 (en) | 2012-02-03 | 2023-04-25 | Axxin Pty Ltd | Nucleic acid amplification and detection apparatus and method |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
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US4353868A (en) * | 1981-05-29 | 1982-10-12 | Sherwood Medical Industries Inc. | Specimen collecting device |
US5084245A (en) * | 1988-11-07 | 1992-01-28 | Hygeia Sciences, Inc. | Assay device for swab borne analytes |
WO1993000994A1 (en) * | 1991-07-02 | 1993-01-21 | Amersham International Plc | Sampling device |
WO1993012421A1 (en) * | 1990-12-13 | 1993-06-24 | Nason, Frederic, L. | Specimen test unit |
WO1995025948A1 (en) * | 1994-03-22 | 1995-09-28 | Celsis International Plc | Sample collecting and assay device |
WO1996014570A1 (en) * | 1994-11-07 | 1996-05-17 | Idexx Laboratories, Inc. | Self-contained signal generating sampling device and methods of use of same |
-
1996
- 1996-12-16 GB GBGB9626101.1A patent/GB9626101D0/en active Pending
-
1997
- 1997-12-16 WO PCT/GB1997/003458 patent/WO1998027196A1/en active Application Filing
- 1997-12-16 AU AU77385/98A patent/AU7738598A/en not_active Abandoned
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4353868A (en) * | 1981-05-29 | 1982-10-12 | Sherwood Medical Industries Inc. | Specimen collecting device |
US5084245A (en) * | 1988-11-07 | 1992-01-28 | Hygeia Sciences, Inc. | Assay device for swab borne analytes |
WO1993012421A1 (en) * | 1990-12-13 | 1993-06-24 | Nason, Frederic, L. | Specimen test unit |
WO1993000994A1 (en) * | 1991-07-02 | 1993-01-21 | Amersham International Plc | Sampling device |
WO1995025948A1 (en) * | 1994-03-22 | 1995-09-28 | Celsis International Plc | Sample collecting and assay device |
WO1996014570A1 (en) * | 1994-11-07 | 1996-05-17 | Idexx Laboratories, Inc. | Self-contained signal generating sampling device and methods of use of same |
Cited By (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1999031218A1 (en) * | 1997-12-16 | 1999-06-24 | Celsis International Plc | Sample-collecting and assay device |
US6653147B2 (en) | 2000-03-31 | 2003-11-25 | Neogen Corporation | Apparatus and method for chemiluminescent assays |
US6927851B2 (en) | 2000-03-31 | 2005-08-09 | Neogen Corporation | Methods and apparatus to improve the sensitivity and reproducibility of bioluminescent analytical methods |
US7229783B2 (en) | 2000-08-01 | 2007-06-12 | Charm Sciences, Inc. | Method for monitoring hygiene |
WO2002055730A2 (en) * | 2001-01-11 | 2002-07-18 | Hygiena Llc | Hygiene monitoring |
WO2002055730A3 (en) * | 2001-01-11 | 2003-05-15 | Hygiena Llc | Hygiene monitoring |
WO2005068969A1 (en) * | 2003-12-23 | 2005-07-28 | Kimberly-Clark Worldwide, Inc. | Self-contained swab-based diagnostic systems |
US7098040B2 (en) | 2003-12-23 | 2006-08-29 | Kimberly-Clark Worldwide, Inc. | Self-contained swab-based diagnostic systems |
US7863053B2 (en) | 2003-12-23 | 2011-01-04 | Kimberly-Clark Worldwide, Inc. | Swab-based diagnostic systems |
GB2422663A (en) * | 2005-01-27 | 2006-08-02 | Martyn Johnson-Townley | Device for surface assay |
EP1848999A2 (en) * | 2005-02-16 | 2007-10-31 | Ping Epitope Diagnostics Gao | Fecal sample test device and methods of use |
EP1848999A4 (en) * | 2005-02-16 | 2012-05-30 | Gao Ping Epitope Diagnostics | Fecal sample test device and methods of use |
WO2010129727A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Coated substrates comprising a cell extractant and biodetection methods thereof |
WO2010129726A1 (en) * | 2009-05-06 | 2010-11-11 | 3M Innovative Properties Company | Articles with matrix comprising a cell extractant and biodetection methods thereof |
US11634758B2 (en) | 2012-02-03 | 2023-04-25 | Axxin Pty Ltd | Nucleic acid amplification and detection apparatus and method |
DE102013014901A1 (en) * | 2013-09-06 | 2015-03-12 | Testo Ag | Method for testing a sample for microorganisms and / or viruses and corresponding swabs |
US20200278368A1 (en) * | 2017-09-27 | 2020-09-03 | Axxin Pty Ltd | Diagnostic test system and method |
US11709175B2 (en) * | 2017-09-27 | 2023-07-25 | Axxin Pty Ltd | Diagnostic test system and method utilizing a closure/sample dispensing mechanism to dispense a sample subvolume for testing |
WO2023034995A1 (en) * | 2021-09-06 | 2023-03-09 | Becton, Dickinson And Company | Method of piercing seal for sample testing |
Also Published As
Publication number | Publication date |
---|---|
AU7738598A (en) | 1998-07-15 |
GB9626101D0 (en) | 1997-02-05 |
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