WO2004003515A2 - Kits d'echantillonnage, dispositifs et procedes d'utilisations associes - Google Patents

Kits d'echantillonnage, dispositifs et procedes d'utilisations associes Download PDF

Info

Publication number
WO2004003515A2
WO2004003515A2 PCT/GB2003/002800 GB0302800W WO2004003515A2 WO 2004003515 A2 WO2004003515 A2 WO 2004003515A2 GB 0302800 W GB0302800 W GB 0302800W WO 2004003515 A2 WO2004003515 A2 WO 2004003515A2
Authority
WO
WIPO (PCT)
Prior art keywords
sampling
container
handle
head
sampling head
Prior art date
Application number
PCT/GB2003/002800
Other languages
English (en)
Other versions
WO2004003515A3 (fr
Inventor
Manuel Vicente Sanchez-Felix
Martin Adrian Devonshire
Ernest Poku
Original Assignee
Sciona 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 Sciona Limited filed Critical Sciona Limited
Priority to US10/519,147 priority Critical patent/US20050252820A1/en
Priority to AU2003236925A priority patent/AU2003236925A1/en
Publication of WO2004003515A2 publication Critical patent/WO2004003515A2/fr
Publication of WO2004003515A3 publication Critical patent/WO2004003515A3/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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • 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
    • 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

Definitions

  • the present invention relates to sampling kits and sampling devices.
  • it relates to swab kits for taking and analysing biological samples.
  • Biological samples can be used to obtain and analyse DNA.
  • DNA is usually extracted from such samples using known DNA purification techniques.
  • the aim of such techniques is typically to produce a preparation of DNA roughly 40-150 Kb in length, representing the genetic information within a cell.
  • DNA isolation techniques exploit both the physical and chemical properties of DNA molecules. Cell lysis and protein denaturisation is accomplished simultaneously using proteolytic enzymes, chemical denaturants and heat. DNA can be separated and purified by sorting out (Miller et al, 1998, Nucleic Acids Research, Vol. 16, page 1215) or by reversing binding to a matrix. Modern isolation techniques can allow isolation and purification of DNA in a relatively short time, e.g. 20-30 minutes.
  • a swab is typically used.
  • the swab is self-administered by the subject.
  • Typical swabs have a handle and a swab head (here also referred to as "sampling head") .
  • the swab head is brushed over the inside surface of the subject's cheek to scrape away some buccal cells.
  • the swab is stored in a container for storage before analysis can be carried out.
  • a particular advantage of buccal cell samples is that such samples can be transported safely by mail. Furthermore, they can be stored for lengthy periods of time whilst still yielding high quality DNA after storage.
  • Known swabs include: swab TS/19-M of Technical Service Consultants Ltd.; IsoSwabTM (Ref: ISO-SWAB) of Schleicher & Schuell Inc.; Catch-AllTM Sample Collection Swab of Epicentre, Madison WI 53713 USA; and the foam- tipped applicator of Whatman International Ltd., Maidstone, Kent ME16 0LS, UK.
  • the main product on the market for buccal cell sampling has been the OmniswabTM of Whatman International Ltd. (catalogue number WB10-0004) .
  • This swab has a tubular handle with a serrated swab head mounted at a slit in a first end.
  • a plunger extends through the length of the handle and away from the second end of the handle. A user can depress the plunger to remove the swab head from the handle. Therefore, after sampling, the swab head can be removed from the handle without the user touching the swab head. This can help to avoid contamination of the sample with other samples or with other external contaminants.
  • a problem with the Whatman OmniswabTM is that the nature of the swab head detachment system requires that only a narrow surface area of the swab head is available to rub against the cheek for capture of buccal cells. Therefore, although the swab provides a mechanism for detachment of the swab head from the handle, the yield of biological material from the swab head is often unsatisfactory. This problem is exacerbated by the fact that the swab head is made from absorbent material. This material typically swells during processes to isolate DNA from the buccal cells and the material also absorbs DNA. This reduces yet further the yield of DNA from the swab head.
  • a first development of the present invention has several aspects, which are discussed below.
  • the first development uses engagement means associated with a container into which the head is to be received, or associated with a closure of the container, to detach a sampling head. This can reduce the risk of contamination and also allows the number of processing steps involved with sampling and/or analysis of the sample to be reduced.
  • the first development of the present invention provides: a sampling kit having a sampling device with a sampling head and a handle; a container for receiving the sampling head; and, optionally, a closure for closing an open end of the container, wherein the container or closure has engagement means arranged so that the sampling head is detachable from the handle by engaging the sampling head with the engagement means and moving the handle with respect to the engagement means.
  • the sampling head may be removed from the handle in a way which reduces the risk of contamination from a user, in particular by simplifying the construction of the handle.
  • the present invention provides a use of a sampling kit according to the first aspect to take a biological sample from a subject or location, with the optional further steps of storing and/or processing the sample.
  • the present invention preferably provides a use (or a method of operation) of a sampling device to take a biological sample from a subject, the sampling device having a handle and a detachable sampling head, the use including the step of engaging the sampling head with engagement means of a container or of an associated closure and moving the handle with respect to the engagement means to detach the sampling head from the handle, with the optional further steps of storing and/or processing the sample.
  • the detached sampling head can be separated from the handle so that the sampling head can be located in the container without the handle.
  • the sampling device of the third aspect is part of the sampling kit of the first aspect.
  • the optional or preferred features which follow may be applied to any or all of the first, second or third aspects .
  • the handle has a distal end and a proximal end.
  • the proximal end is for handling by a user.
  • the sampling head is detachably supported around a support portion at the distal end of the handle. In this way, the sampling head may embrace the support portion of the distal end of the handle.
  • the sampling head is connected to the support portion by at least one frangible connection extending therebetween. Breakage of said at least one frangible connection can allow the detachment of the sampling head from the support portion.
  • the sampling head may be at least partially hollow. This can have the advantageous effect that, before the sampling head is detached from the handle, there is a space suitable for sample retention between an internal surface of the sampling head and a surface of the support portion.
  • the sampling head may be formed so that, in use, once detached from the handle, it presents an aperture.
  • the aperture becomes enlarged compared to the cross-sectional area of the handle during detachment of the sampling head from the handle.
  • the sampling head preferably is splittable into two or more segments, thereby allowing exposure for analysis of sampled material held inside the sampling head.
  • the segments of the sampling head which split apart may abut the inner surface of the container. This has the advantage that the segments of the sampling head can be disposed away from the central axis of the container, so that they do not impede the subsequent insertion of probes into the container to carry out processes on the sample.
  • the sampling head is formed of a material which substantially does not absorb DNA and/or water.
  • the sampling head material can allow a large proportion of the sample collected to be available for subsequent processing.
  • the sampling head may be attached to the support portion of the handle via one or more releasable attachments. Such attachments may be re- attachable.
  • the sampling kit is typically manufactured for single use applications (e.g. supplied sterile or clinically clean for biological material sampling)
  • the sampling head is typically attached to the support portion by one or more breakable attachments.
  • the head may be attached to the handle via a series of breakable links extending from the end portion of the shaft to the sampling head.
  • the breakable links connecting the handle to the sampling head typically extend from the support portion to the internal surface of the sampling head.
  • a particular advantage associated with a hollow sampling head is that some biological material to be sampled can be held within the head. This can help to improve the sampling efficiency of the sampling kit.
  • a further advantage associated with a hollow sampling head is that a retention volume, in which biological material can be disadvantageously retained during an isolation procedure subsequent to a sampling step, is advantageously reduced in comparison to a non- hollow sampling head of similar outer dimensions. This is particularly the case if the sampling head is capable of being split to allow access to biological material held within the sampling head.
  • This advantage can be enhanced by using a material for the sampling head which does not absorb water and/or DNA material. The yield of DNA material from the sampling head can consequently be increased.
  • the sampling head has an undulating outer surface. This can improve the material collecting efficiency of the sampling head, particularly when the material to be collected is in part abraded from its ' source.
  • Typical surface configurations include ribbed, toothed, bobbled, dimpled, etc.
  • a smooth outer surface of the sampling head is suitable. A smooth outer surface may be useful for sampling from people with sensitive mouths or for sampling from open wounds. Furthermore, a smooth outer surface may be useful for cleaning validation of process equipment used for the manufacture of drugs or chemicals or biological or fluid products.
  • the material of the sample head may be selected to provide a gentle surface texture.
  • sampling head material which does not absorb DNA or water
  • This allows the yield of DNA to be improved by substantially avoiding absorption of DNA by the sampling head material.
  • the sampling head material does not absorb water
  • aqueous solutions or buffers can be more easily recovered from processes subsequent to the sampling step. Consequently, the sampling head can be left in the container during the subsequent processing steps. Avoiding the need to remove the sampling head from the container avoids yet another step by which the contents of the container could become contaminated.
  • the material of the sampling head may be a semirigid plastics material, such as suitably processed polypropylene, e.g. melt-blown (typically 100% melt- blown) polypropylene.
  • Other materials suitable for the sampling head include polyethylene, PBT (polybutylene tetraphalate), nylon 6, nylon 11, polycarbonate, poly (4-5 methylpentene-1) , polystyrene and polyethylene terephthalate.
  • polyethylene polyethylene
  • PBT polybutylene tetraphalate
  • nylon 6, nylon 11 polycarbonate
  • poly (4-5 methylpentene-1) polystyrene
  • polyethylene terephthalate polyethylene terephthalate
  • any polymer suitable for melt blowing can be used to form the sampling head.
  • the fibres of the sampling head typically have a round cross- section. However, square, rectangular, triangular, pie segment and cross-shaped fibres may be used.
  • sampling devices have sampling heads formed using polypropylene, e.g. melt blown polypropylene.
  • the average fibre diameter in the sampling head may be 1 ⁇ m or more, preferably 5 ⁇ m or more.
  • the average fibre diameter in the sampling head may be 20 ⁇ m or less, preferably 10 ⁇ m or less.
  • the engagement means is formed at a surface of the closure. This allows the engagement means to be formed separately from the container, allowing the use of readily available containers of a standard size.
  • the engagement means may have a tapering shape to assist, in use, detachment and/or segmentation of the sampling head.
  • the tapering shape preferably tapers in cross-sectional area in a direction along the principal axis of the container, when the closure is fitted on the container.
  • the engagement means may be, for example, convex or concave. If convex, the engagement means may taper to increase the cross-sectional area of the engagement means in the direction of movement of the handle to remove the sampling head. In this way, the sampling head can be prised from the handle, for example by a wedqing action. If convex, the surface of the engagement means is preferably conical or frusto-conical .
  • the engagement means may taper to decrease the bore area of the engagement means in the direction of movement of the handle to remove the sampling head. In this way, the sampling head can be squeezed from the handle.
  • the engagement means may be a suitably shaped slot in the closure.
  • the handle of the sampling device is slidable within the closure, to enable detachment of the sampling head by the engagement means.
  • the closure may be separable from the container.
  • the assembly of the closure and sampling device may be mounted on the container by inserting the sampling head and part of the handle into the container and attaching the closure to the container. Subsequent withdrawal of the handle from the container through the closure may cause detachment of the sampling head.
  • the closure may include an aperture in which the handle of the sampling device is slidable, the aperture being closable substantially to seal the closure when the handle is removed from the closure.
  • the closure includes an adapter such as a cap and sealing means shaped to cooperate with the adapter substantially to seal the adapter.
  • the adapter may be connectable to the container at the open end of the container.
  • the aperture may be formed through the adapter.
  • the engagement means may be formed on a surface of the adapter.
  • the engagement means is an aperture through the adapter, shaped (e.g. as an elongate slot) to allow the sampling head through the adapter in a first rotational position and to prevent the sampling head passing through the adapter in a second rotational position.
  • the sampling kit may include a cap which is connectable to the container, the cap having engagement means allowing detachment of the sampling head from the handle.
  • the container may be a container of a standard form and the cap may be fixable to the container, for example by means of a cooperating screw thread, by adhesive or by welding (e.g. ultrasonic welding).
  • the sealing means is attachable to the container via attachment means independent of the cap.
  • the sealing means may be attached to the container independently from the cap, for example to ensure that the sealing means is not lost during use of the kit.
  • the attachment means may include a resilient ring attachable around the container.
  • the ring may be attached to the sealing means by a resilient link.
  • the sealing means may be a plug shaped to cooperate with an opening in the cap. The function of the sealing means is typically to seal the cap to ensure that sample is not lost from the container, for example through the aperture of the closure through which the handle is slidable.
  • the engagement means is formed on an internal surface of the container.
  • the kit may not include a closure.
  • the container may be a tube which is closed at one end and open at the other end to receive the sampling head.
  • the engagement means may, for example, be a lip, step, barb or slot formed on the internal surface of the container and shaped and/or directed to allow the sampling head to pass into the container in an entry direction, but not in an exit direction, to detach the sampling head from the handle. Using this arrangement, the sampling head can be trapped in the container as it is detached from the handle.
  • the engagement means may comprise a tapering internal cross-section of the container.
  • the internal surfaces of the container may be shaped, for example, so that the distance between opposing internal surfaces of the container changes with distance along the container.
  • the change in cross-section of the container may be gradual along at least a part of the axial length of the container.
  • an internal cross-section dimension of the container may reduce with depth from the open end of the container.
  • the internal sectional shape of the container is equilateral, e.g. square, circular, hexagonal, etc.
  • the internal cross-sectional area of the container may also correspondingly change with depth.
  • the sampling head may be inserted into the container until it is jammed between opposing internal surfaces of the container. Further insertion of the handle into the container may then detach the sampling head from the handle, following which the handle can be removed from the container.
  • the container may have a flexible portion, for example one or more flexible walls. In that case, the engagement means may be the internal surfaces of said flexible walls.
  • a user can detach the sampling head from the handle by inserting the sampling head into the container and holding the sampling head with respect to the container by pressing or squeezing the sampling head by pressing or squeezing an appropriate part of the container, and then moving the handle to detach the sampling head.
  • the container is typically of a standard size and shape.
  • the container is preferably the same container as used for further processing of the sample collected by the sampling kit.
  • Such further processing may include an assay such as an analysis of the sample collected by chemical, biological, biochemical, forensic, etc. testing or testing involving the clean validation of process equipment used for the manufacture of drugs or chemicals or biological or food products. It is often advantageous to carry out such testing using automated equipment for the introduction of reagents and the subsequent analysis of the product (s).
  • automated equipment has the advantage of reliability, reproducibility and standardisation, sample identification tracking, along with a smaller risk of contamination, over conventional non-automated analysis.
  • automated equipment can run very many similar tests at the same time, reducing the overall time required for carrying out a large number of tests.
  • the container being suitable for at least one of such plates.
  • a rack allowing an array of up to 32 containers is envisaged.
  • the volume of the containers may be at least 0.1 ml, about 0.25 ml or up to 2 or 2.5 ml, and/or at most 4 or 3.5 ml.
  • the sampling kit may be used for applications other than DNA assays.
  • the sampling kit may be used for protein assays and/or for cleaning validation of process equipment to be used in the manufacture of drug products/substances or other pharmaceuticals, foods processing/products, chemicals or biological processing/products.
  • the container used in the sampling kit is compatible for use in standardised automated assay equipment.
  • the container is shaped and dimensioned to be suitable for multi-well (e.g. 32-well or 96-well) testing.
  • the container may be an individual container, or it may be attached to other (typically similar) container in an array suitable for a multi-well (e.g. 32-well or 96-well) assay.
  • the container has an internal depth of at least 10 mm. Preferably the depth is at least 30 mm. Typically the container has an internal depth of at most 200 mm, preferably at most 80 mm. Typically, the container has an internal width at its open end of at least 4 mm, preferably at least 6 mm. Typically, the container has an internal width at its open end of at most 15 mm, preferably at most 11 mm.
  • the container typically has a volume of about 1.2 ml, but volumes of 0.25, 0.5, 0.8 and 2 ml (and others in this range) may also be used.
  • the containers preferably have a rounded internal cross-sectional shape. However, it is possible for the containers to have an angular, e.g. rectangular cross- sectional shape.
  • the sampling device may also be adapted to be more suited to automated assay techniques.
  • the sampling head may be formed so that, once detached from the handle, it presents an aperture.
  • the aperture may be formed at that part of the sampling head though which the handle extends before the sampling head is detached from the handle.
  • the aperture may take the shape of the handle at that part of the sampling device.
  • the sampling head is preferably hollow, so that it may hold sampled material.
  • the aperture typically allows access to the sampled material held within the sampling head.
  • the aperture is therefore preferably of a suitable size and shape to allow access to the interior of the sampling head to, e.g., reagents and/or probes.
  • the aperture may be of a different size and shape to the size and shape of the handle.
  • the aperture may become enlarged compared to the cross- sectional area of the handle during the detachment process. Dilatation of the aperture may be achieved by respective sides of the sampling head splitting apart.
  • the sampling head In the intact sampling device, the sampling head may be formed in different, e.g. longitudinal, segments which are connected along lines of weakness. Subsequent detachment of the sampling head from the handle may cause the segments to break apart, for example around the aperture, thereby dilating the aperture.
  • the sampling head may split into two or more parts, thereby exposing sampled material for analysis. In preferred embodiments, the parts of the sampling head which split apart abut the inner surface of the container.
  • a probe e.g. an automated probe
  • the sampling head may be non-symmetrical. In particular, it may have a first width measured in one direction which is greater than a second width measured in another direction. Put another way, the sampling head may have a flattened configuration. This is particularly applicable where the engagement means of the container for detaching the sampling head is the tapering walls of the container or closure. In that case, the sampling head may be detached from the handle by pressing the sampling device, head first, into the container. At the part of the container at which the first width is the same as the internal width of the container, the sampling head touches opposing internal surfaces of the container. Further insertion of the sampling head into the container may cause the sampling head to deform, thereby breaking a connection between the sampling head and the handle. The deformation may cause the sampling head to split or partially split into segments.
  • the sampling head and handle may assist in splitting the sampling head apart. Removal of the handle back through the sampling head may further separate the segments of the sampling head. The configuration of the remains of the breakable connections between the handle and the sampling head may assist in this.
  • the engagement means is formed on the closure, the sampling head may be detached when the handle is drawn away from the container, the detachment process otherwise taking a similar form.
  • the engaging means of the container is a discontinuity such as a step, lip or barb on the internal surface of the container
  • the change in internal diameter (or internal width) of the container at the discontinuity should usually be at least about 2 mm.
  • the internal width at the narrowest part of the container around the discontinuity should be at least about 2 mm smaller than the width (e.g. the largest width) of the sampling head.
  • the detachment of the sampling head from the handle typically comes when the sampling device is being removed from the container, catching the sampling head on the discontinuity. Further removal of the handle typically breaks the connection between the sampling head and the handle.
  • the shape of the handle and/or the shape of the broken connection between the handle and the sampling head may be chosen to allow the sampling head to be split apart (either partially or wholly) as the handle is further extracted from the container.
  • the sampling head is typically detached from the handle by being forced against the engagement means. Again, the sampling head may be split apart by interaction between the broken connecting elements attached to the handle.
  • the shape of the engagement means also has a role to play.
  • the engagement means may have a tapering shape extending into the container (e.g. a wedge shape or a frusto-conical shape) when the closure is attached to the container. Then the sampling head may be split apart (either wholly or partially) by being forced along the tapering shape of the engagement means as the handle is withdrawn from the container.
  • closure is intended to include a lid, stopper, cap or bung or other equivalent closing means.
  • the engagement means may be formed by an extension or attachment of the closure.
  • the engagement means when the closure is in place closing the container, the engagement means, although connected to the closure, may be located some distance away from the opening end of the container.
  • the closure may have an extended neck portion which extends into the container, towards the closed end of the container.
  • the neck portion extends at least 50%, or preferably at least 75% along the longitudinal axis of the container, towards the closed end (e.g. the base) of the container.
  • the closed end e.g. the base
  • Having the engagement means relatively close to the base of the container allows the sampling head to be detached from the handle at a location relatively close to the base of the container. In this way, the sampling head is less likely to become stuck between the walls of the container at a location away from the base of the container.
  • the extended neck may include guide means.
  • This guide means may cooperate with corresponding means (e.g. a groove, ridge or lug) formed on the handle.
  • the guide means preferably extends along a predetermined portion of the neck, from the engagement means.
  • an end of the guide means away from the engagement means may provide a stop limit for movement of the handle with respect to the next.
  • this stop limit allows the swab head to be detached from the handle by the engagement means before the stop limit is reached.
  • the handle and lid may be removed from the container together, e.g. by pulling the handle.
  • the cooperation of the stop limit of the guide means and the handle can thereby allow removal of the lid and handle in a single operation. This may, for example, be done robotically, e.g. prior to DNA isolation processing.
  • the sampling head is formed of a material which is sufficiently rigid to allow the sampling head to split open during (or after) detachment of the sampling head from the handle by the engagement means. Suitable materials are mentioned above.
  • the rigidity of the sampling head is determined by its shape and by the material used. The rigidity also determines (in part) the abrasiveness of the sample head, to obtain high yields of cells/DNA.
  • the sampling head material is selected so that the sampling head is substantially not capable of absorbing water or DNA.
  • the sampling head is preferably formed in two segments. These segments are typically of similar size and shape. They are typically formed as one piece, with one or more lines of weakness joining them, or they are formed as separate pieces which are subsequently bonded together (the bonds forming lines of weakness) . During detachment from the handle, the segments preferably split apart.
  • the sampling head is preferably joined to the handle by a series of breakable attachment elements. These may be attachment fingers or lattices. Preferably, these elements break at their connection with the sampling head. In this way, once the sampling head is detached from the handle, the connection elements remain attached to the handle and are removable from the container with the handle.
  • the connection elements are typically protruding elements. They may, for example, protrude from the handle to a width as great at the width of the sampling head, or slightly smaller. They may provide the sampling head with rigidity, particularly where the sampling head has a flattened configuration. They may be attached to the sampling head at a line of weakness, e.g. at a join between segments of the sampling head.
  • the dimensions of the sampling head are chosen with respect to the container which will be used with the sampling device.
  • the length of the sampling head may be about 10-20 mm, preferably about 17 mm.
  • the width in one direction may be about 5-8 mm, preferably about 7 mm.
  • the width in another direction may be about 2-5 mm, preferably about 3-3.5 mm.
  • a sampling kit having: a sampling device with a sampling head and a handle; a container for receiving the sampling head; processing means for initiating sample processing of sample collected, and, optionally, a closure for closing an open end of the container, wherein the processing means is locatable or located in the container.
  • processing means for initiating sample processing of sample collected, the processing means being locatable or located in the container.
  • processing means In the first or the second aspect, the inclusion of processing means into the kit allows a later processing step to be avoided. Typically, each processing step requires invasion of the sample held in the container. Thus, the reduction in processing steps reduces the chances of contamination of the sample.
  • a sampling kit according to the first or second aspect of the second development to take a biological sample from a subject or location, with the optional further steps of storing and/or processing the sample.
  • the third aspect further includes the step of carrying out at least one of a DNA/RNA assay, forensics, chemical, biological, microbiological sampling, or cleaning validation of process equipment to be used for pharmaceuticals, foods, proteins or biological species.
  • a DNA/RNA assay forensics, chemical, biological, microbiological sampling, or cleaning validation of process equipment to be used for pharmaceuticals, foods, proteins or biological species.
  • Preferred and/or optional features of the first, second or third development are mentioned below. Any aspect or optional feature of the second development may be combined with any aspect or optional feature of the first development.
  • the processing means is capable of initiating or performing cell lysing on sample held, in use, in the container.
  • Handling of a fluid sample can be simplified by allowing the sample to be absorbed into an absorbent material such as filter paper. Subsequent drying of the paper can allow retention of useful biological material in or on the paper. Typically, this can be handled more easily than the original fluid sample, e.g. parts of the paper can be cut away for further analysis by rehydration of the sample.
  • an absorbent material such as filter paper.
  • the processing means is as absorbent cover means to allow, in use, sample held by the sampling head to transfer to the cover means.
  • the absorbent material may be an impregnated paper or fabric which is capable of yielding amplifiable nucleic acid from suitable biological material, such as buccal cells.
  • the absorbent covering means may be configurable to be interposed between the sampling head and an inner surface of the container. This can allow efficient transfer of sample from the sampling head to the absorbent covering means.
  • there is included the step of transferring sample from the sampling head to the absorbent material by receiving the sampling head in the cover means formed of the absorbent material.
  • the absorbent cover means may be a sheet of absorbent material configured to define a shape which is able to cooperate with the shape of the sampling head.
  • the cover means may be shaped to enclose or embrace (at least partially but preferably wholly) the sampling head.
  • the cover means may be a sleeve, collar or tube and may be open or closed.
  • Absorbent material which can not only help in the storage of biological samples, but which also can initiate processing of the sample.
  • IsoCodeTM paper available from IsoCodeTM
  • the cover means is preferably formed from a material which is capable of interacting with biological material to release nucleic acid(s).
  • the biological material may be cellular material or virus particles, for example.
  • the interaction between the biological material and suitable material for the cover means may be a disrupting or lysing interaction for cellular material or a disrupting interaction for virus particles.
  • the kit is to be used for assays of double stranded DNA (dsDNA) , as found in nucleated cells, but is also suitable for other DNA such as ssDNA or other nucleic acids such as RNA (e.g. ssRNA, dsRNA, tRNA or rRNA) , mitochondrial DNA, plasmid/bacterial DNA samples, etc.
  • the absorbent material is preferably an impregnated (or otherwise treated) paper or fabric which is capable of yielding amplifiable nucleic acid from suitable biological material, such as buccal cells.
  • the absorbent covering means is preferably configurable to be interposed between the sampling head and an inner surface of the container.
  • the covering means is pressed between the sampling head and the inner surface of the container.
  • the cover means may be disposed in the container, i.e. prior to the sample head being received by the cover means.
  • the cover means may be a lining (e.g. a partial lining) of the container.
  • the container and the cover means may be separate.
  • the use may include the step of locating the cover means in the container. This step may take place before or after the sampling head is received by the cover means.
  • Fig. 1 is a schematic longitudinal cross-sectional view of a kit according to an embodiment of the invention.
  • Fig. 2 is a schematic lateral cross-sectional view along line A-A' in Fig. 1.
  • Fig. 3 is a schematic longitudinal cross-sectional view of the kit of Fig. 1 with the swab further inserted.
  • Fig. 4 is a schematic lateral cross-sectional view along line B-B' in Fig. 3.
  • Fig. 5 is a schematic longitudinal cross-sectional view of the kit of Fig. 3 with the swab still further inserted.
  • Fig. 6 is a schematic lateral cross-sectional view along line C-C in Fig. 5.
  • Fig. 7 is a schematic longitudinal cross-sectional view of the kit of Fig. 5 with the handle of the swab being removed from the container.
  • Fig. 8 is a schematic lateral cross-sectional view along line D-D' in Fig. 7.
  • Fig. 9 is a schematic longitudinal cross-sectional view of a container for use in a kit according to an embodiment of the present invention.
  • Fig. 10 is a schematic longitudinal cross- sectional view of an alternative container for use in a kit according to an embodiment of the present invention.
  • Fig. 11 is a schematic longitudinal cross- sectional view of a kit according to an embodiment of the invention .
  • Fig. 12 is a schematic longitudinal cross- sectional view of a kit according to another embodiment of the invention.
  • Fig. 13 is a schematic longitudinal cross- sectional view of an alternative stopper for use with the kit shown in Fig. 12.
  • Fig. 14 is a schematic lateral cross-sectional view along line E-E' in Fig. 13.
  • Fig. 15 is a schematic longitudinal cross- sectional view of another alternative stopper for use with the kit shown in Fig. 12.
  • Fig. 16 is a schematic lateral cross-sectional view along line F-F' in Fig. 15.
  • Fig. 17 is an enlarged, schematic, exploded view of one end of a swab for use in or with embodiments of the invention.
  • Fig. 18 is an enlarged, schematic, exploded view of one end of another swab for use in or with embodiments of the invention.
  • Fig. 19 is an enlarged, schematic, exploded view of one end of a further swab for use in or with embodiments of the invention.
  • Fig. 20 is an enlarged, schematic, exploded view of one end of a further swab for use in or with embodiments of the invention.
  • Fig. 21 is a schematic, exploded, partial longitudinal cross-section of a kit according to an embodiment of the invention.
  • Fig. 22 is a schematic longitudinal cross-section of part of a kit according to another embodiment of the invention.
  • Fig. 23 is a schematic longitudinal cross-section of a kit according to another embodiment of the invention.
  • Fig. 24 shows the kit of Fig. 23 with the stopper in place closing the container.
  • Fig. 25 shows the kit of Figs. 23 and 24 after detachment of the sampling head from the swab handle.
  • Fig. 26 is a schematic longitudinal cross-section of a kit according to an alternative embodiment of the invention.
  • Fig. 27 shows the kit of Fig. 26 with the stopper in place closing the container.
  • Fig. 28 shows the kit of Figs. 26 and 27 during removal of the stopper and swab handle from the container.
  • Fig. 29 shows a schematic view of the stopper only, along line G-G' in Fig. 27.
  • Fig. 30 is a schematic longitudinal cross-section of a kit according to another embodiment of the invention, without the swab.
  • Fig. 31 is a schematic lateral cross-sectional view along line H-H' in Fig. 30.
  • Fig. 32 is a schematic longitudinal cross- sectional view of the kit of Fig. 30 with the swab inserted in a first rotational position.
  • Fig. 33 is a schematic longitudinal cross- sectional view of the kit of Fig. 30 with the swab in the second (head detachment) rotation position.
  • Fig. 34 is a schematic longitudinal cross- sectional view of the kit of Fig. 30 with the swab head detached, the swab handle removed and the stopper lid sealing the adapter.
  • Fig. 35 is a schematic longitudinal cross- sectional view of a kit according to another embodiment of the invention.
  • Fig. 36 is a schematic longitudinal cross- sectional view of the kit of Fig. 35 with the swab head detached, the handle removed and the cap sealing the container.
  • Figs. 1 to 8 illustrate a mode of operation of a kit according to an embodiment of the invention. Like features are given the same reference numerals in these drawings .
  • Fig. 1 shows one end of a swab 10, including a shaft 12 at one end of which is formed a swab head 14.
  • a swab is illustrated in more detail in Fig. 17.
  • Fig. 17 there is shown an enlarged exploded view of the structure of the swab 10.
  • the shaft 12 narrows to a constriction 16 which leads to a flattened tongue portion 18.
  • Connection elements 20 project from the narrow sides of tongue portion 18.
  • the swab head 14 is composed of two opposing segments 14a and 14b. Segments 14a and 14b are lightly bonded to each other at their peripheries, embracing the tongue 18.
  • Connection elements 20 provide some extra stiffness to the structure and may be sandwiched in the bond between the segments 14a and 14b.
  • the upper ends 22a and 22b of the segments 14a and 14b form a collar around the constriction 18 and may be lightly bonded to the surface of the constriction 18.
  • Swab head 14 is made from melt blown polypropylene, typically 100% melt blown polypropylene.
  • the surface of the swab head 14 is ridged. This allows the swab to rub or scrape more sample from a sampling location.
  • the swab is used to sample buccal (cheek) cells from the inside of a subject's mouth.
  • the swab may also be used to take forensic samples, for example.
  • Polypropylene has the advantage that it does not absorb water or DNA. For this reason, it is efficient at transferring high yields of sample.
  • a suitable swab is the Texwipe scourswab, model no.
  • the first step is the sampling step, e.g. a subject rubs the inside surface of their cheek to load cellular material onto the swab head.
  • the cellular material is loaded on the outer surface of the swab head (e.g. between ridges on the swab head) and in the space between the segments 22a, b and the tongue 18. Subsequent steps are shown by Figs. 1-8, which are described in detail below.
  • swab 10 is inserted, head 14 first, into the open end of a tubular container 30.
  • Container 30 has a generally circular cross-section (as shown by
  • Fig. 2 shows a lateral cross-sectional view along line A-A' in Fig. 1.
  • the swab head 14 has a generally oval (or pointed oval) cross-sectional shape
  • the tongue 18 has a generally rectangular cross-sectional shape. With the swab head 14 in the position shown in Figs. 1 and 2, the swab head 14 does not touch both of the inner surface of the side walls 34,36.
  • swab head 14 is pushed further into the container 30 in Fig. 3. At the point shown in Fig. 3, the swab head is pressed lightly between the side walls 34,36 due to the tapering of the side walls 34,36.
  • Fig. 4 shows a lateral cross-section along line B-B' in Fig. 3.
  • Fig. 4 shows that the cross-sectional shape of the swab head 14 changes due to the deformation imposed by the side walls 34,36. The deformation involved is the forcing-apart of the segments 14a, b which make up the swab head 14.
  • Fig. 5 shows the subsequent step where the swab head 14 has been forced as far as it can go into the container 30. At this point, the swab head is jammed between the side walls 34,36 of the container 30. Further forcing of the swab into the container (by a user pressing down on shaft 12) moves the shaft 12 with respect to the swab head 14. The tongue 18 pierces the base of the swab head 14, until the tongue abuts against the inner surface of the base of the container 30. Thus, the shaft 12 moves with respect to the swab head 14 and the constricted portion 16 of the shaft 12 is forced into the swab head 14.
  • the wider portion of the shaft 12 is thereby interposed between the upper portions 22a and 22b of the swab head, forcing the segments 14a, b apart slightly at this location.
  • Fig. 6 shows that the segments 14a, b are moved apart further than in Fig. 4.
  • Fig. 7 the shaft 12 is pulled up from the container 30.
  • the swab head 14 at least partially breaks into its component segments 14a, b by the withdrawal of the tongue 18 and particularly by the broken projecting connection elements 20 which help to break the light bond between the segments 14a and 14b.
  • the segments 14a and 14b break away from each other once the shaft 12 is removed from the container. This leaves a space 38 in the container along the axis of the container.
  • sample held within the swab head is therefore easily accessible, thereby improving the efficiency of the sampling process.
  • the space 38 left along the axis of the container means that it is not necessary to remove the remains of the swab head from the container, since the sample is easily accessible along the axis of the container.
  • the need for removal of the swab head would introduce an element of risk of contamination of the sample. Elimination of this need eliminates that particular risk of contamination.
  • a particular advantage associated with this embodiment is that the space 38 left in the container allows the easy application of automated assaying equipment to the kit.
  • the space 38 allows sample to be extracted easily from the container using automated probes, and equally allows the easy introduction of buffers and/or reagents into the container using automated probes .
  • Suitable containers 30 for the kit are containers which also can be arranged in an array to allow multiple testing of samples held in each container.
  • the containers can be containers (either fixed or removable) for 96 well plates (or microtubes), a standard 8x12 format for genomic automated processes such as DNA testing, e.g. > 1ml tubes.
  • Suitable products include the RiplateTM microtube rack systems (catalogue numbers 602100, 602200, 602300, 602350, 602101, 602201, 602110, 602112, 602400, 602500, 602450, 602550) and the 2.4ml and 1ml deep well plates of the same supplier (catalogue numbers DW850301, DW850276) , all available from Elkay Laboratory Products (UK) Ltd., Basingstoke, Hampshire RG24 8NA, UK.
  • Suitable products are the 2.2ml storage plate, the 2.2ml storage plate Mark II and the 1.2ml storage plate (catalogue numbers AB-0932, AB- 0661, AB-0564, respectively), all available from Abgene, Epsom, Surrey KT19 9AP, UK. Similar plates are available from other manufacturers. Following sampling and introduction and separation of the swab head into the container, DNA testing may be carried out. Suitable DNA isolation kits for use with embodiments of the present invention include those using magnetic bead and filter techniques, e.g. QIAamp DNA blood mini kit (catalogue no. 51104) and QIAamp 96 DNA blood kit (catalogue no.
  • nucleospin multi- 96 blood kit catalog no. K-3062-1
  • nucleospin blood kit mini kits catalog no. K-3052-1
  • Agowa Mag Maxi DNA isolation kit from AGOWA GmbH Glienicker Weg 185, D-12489, Berlin, Germany.
  • magnetic bead kits under development at DRI (DNA Research Innovation Ltd) , 940 Cornforth Drive, Sittingbourne Research Centre, Kent ME9 8PX.
  • FIG. 9 Alternative types of container are illustrated in Figs. 9 and 10.
  • the container 40 has a rounded base 42 with a generally cylindrical outer surface 44.
  • the container does not have tapering walls.
  • the inner surface of the side walls of the container presents a step 48 which increases the cross-section or cross-sectional area of the container in a stepwise fashion in a direction away from the open end 46 of the container.
  • the cross-section of the open end 46 of the container is just large enough to allow the intact swab head to be inserted into the end 46, but with some deformation of the swab head 14 due to pressure against side walls 50,52.
  • the cross-section of the container may taper at the open end 46 to facilitate insertion of the swab head into the container.
  • the swab head passes the step 48, the pressure on the sides of the swab is relaxed and the swab head (being slightly elastic) can return to its original shape. Subsequently, upwards movement of the swab forces the swab head 14 against step 48. The abrupt reduction in cross-section of the container in the upwards direction does not assist the swab head in passing through the constriction. Consequently, the swab head is trapped against the step 48. If the swab handle (shaft
  • Fig. 10 shows a similar container 54 to the container 40 shown in Fig. 9.
  • the container 54 has a tapering section 56 at its inside side surface. This taper is sufficient to deform the swab head 14, but insufficient to detach it from the shaft 12.
  • the tapering section ends abruptly in a step 58 which widens the cross-section of the container again. Removal of the shaft 12 from the container causes the swab head to become detached due to abutment with step 58, in a similar way to that described with respect to Fig. 9.
  • Fig. 11 shows another embodiment of a kit 60 according to the present invention.
  • the kit as illustrated is (schematically) as it would appear to a user before using the kit.
  • a swab 10 is located in a container 62. Again, the swab has shaft 12 and swab head 14.
  • the container has a lid 64 which fits over the side walls of the container. Lid 64 has a hole at its centre through which the shaft 12 of the swab extends. For use, the swab is removed from the container 62 by removing the swab 10 and the lid 64 together from the rest of the container. The lid 64 therefore remains in place with respect to the shaft 12.
  • the swab is used to collect a sample (with the lid still on the shaft) and then the swab is placed back inside the container 62 and the lid reattached over the side walls of the container. Subsequently, the user draws the shaft of the swab upwardly with the lid remaining in place with respect to the rest of the container. When the swab head 14 reaches the lid 64, it presses against it due to the upwards force exerted on the shaft 12 by the user. The inner surface 66 of the lid detaches the swab head from the shaft 12 and the shaft can be removed completely from the container. The detached swab head then falls to the base of the container for further processing/analysis, for example as referred to above with respect to DNA assays or pharmacogenomic or forensic applications.
  • Figs. 12-16 illustrate variations on the embodiment described with respect to Fig. 11.
  • Fig. 12-16 illustrate variations on the embodiment described with respect to Fig. 11.
  • the lid is a stopper 70.
  • the abutment surface 72 of the stopper facing the inside of the container is shaped to facilitate removal of the swab head.
  • the abutment surface 72 of the stopper tapers towards the swab head 14.
  • the surface 72 in Fig. 12 is shown as part of a cone, but other shapes can be used.
  • the shape can be a partial curved cone which tapers non- uniformly, e.g. as shown by surface 74 arranged around hole 76 in Figs. 13 and 14.
  • the surface may include a blade section 78, as shown by Figs. 15 and 16. This assists in separating the segments of the swab head.
  • Figs. 23-25 show an alternative embodiment to the embodiments shown in Figs. 12-16.
  • a container 100 receives an assembly of a swab (consisting of handle 12 and swab head 14) and s stopper 102.
  • Stopper 102 has a sealing cap 104 and an extended neck portion 106.
  • a cylindrical bore 108 is formed along the longitudinal axis of the neck portion 106 and cap 104. Within the cylindrical bore 108 is located the shaft 12 of the swab. The fit between the shaft 12 and the bore 108 is such that stopper 102 and handle 12 are slidable with respect to each other.
  • Fig. 24 shows the kit of Fig. 23 when the stopper is located within container 100.
  • Cap 104 forms a seal (e.g. a fictional seal) with the open end of container 100.
  • the neck portion 106 extends between two-thirds and three-quarters of the axial length of the container 100.
  • the swab head 14 Due to the length of the neck 106, the swab head 14 is located close to the closed end (i.e. base) of container 100.
  • Fig. 25 shows the kit of Figs. 23 and 24 after the swab head 14 has been detached from the swab handle 12.
  • the mode of detachment of the swab head 14 from handle 12 is similar to that described in respect of Figs. 12-16. However, a significant difference between this embodiment and the embodiments described in relation to Figs. 12-16 is the positioning of the tapering contact surface 112 with respect to the container 100. Since it is the abutment between the swab head 14 and surface 112 which acts to detach the swab head 14 from the handle 12 (on relative movement between the swab handle 12 and the stopper 102), the detachment takes place at a position which is deep inside container 100. For this reason, the swab head 14 has only a small distance to travel to rest at the base of container 100.
  • An advantage here is that, by ensuring that the swab head 14 is located deep within container 100, it is less likely that the swab head will interfere with subsequent processing. In particular, ensuring that the swab head 14 does not become trapped at a shallow portion of container 100 allows probes (e.g. robotic probes) to be inserted part way into container 100 during subsequent processing of the biological sample (e.g. DNA assaying).
  • probes e.g. robotic probes
  • stopper 102 may be releasably attached to handle 12.
  • the advantage of this is that the stopper may be used as a handle by the user of the swab. This is helpful because a thicker handle is easier for a user to manipulate.
  • the means attaching stopper 102 to handle 12 can be a frangible connection between the two. The frangible connection is broken, for example, when the stopper is brought into engagement with the container. Then handle 12 can be moved with respect to stopper 102 in order to detach the swab head from the handle, as described with respect to Figs. 23-25.
  • Figs. 26-29 show another modification of the embodiment described in relation to Figs. 23-25.
  • Stopper 102 again has an extended neck portion 106. However, in this case, a pair of slots 114 is formed in neck portion 106. Slots 114 extend axially from end 110 of the neck portion to a stop limit 116. Slots 114 communicate with cylindrical bore 108. Slots 114 are shown in Fig. 29.
  • Handle 12 includes protruding lugs or arms 118.
  • Arms 118 are shaped to be able to slide along slots 114 up to the stop limit 116.
  • Fig. 27 shows the kit after cap 104 has closed the open end of container 100. Furthermore, handle 12 has been moved upwardly with respect to stopper 102 in order to detach swab head 14 from the handle. The upwards travel of handle 12 is limited by the abutment of arms 118 with stop limit 116 of slots 114. As shown in Fig. 28, the handle 12 and the stopper
  • stopper 102 can be removed from the container by pulling on handle 12. In this way, the number of steps required to prepare the sample for analysis can be reduced. In particular, the removal of stopper 102 with handle 12 is suited to robotic processing of the sample. The reduction in the number of processing steps and the suitability for large scale robotic analysis can reduce the risk of contamination (including cross-contamination) of the sample.
  • Fig. 30 shows a schematic longitudinal cross- sectional view of another embodiment of the invention.
  • the swab is not shown in Fig. 30.
  • Fig. 30 shows the container 200 with an adapter 210 attached to the open end of the container by ultrasonic welding.
  • the adapter may be attached via cooperating screw threads at the outer wall of container 200 and the inner wall of adapter 210.
  • a rubber stopper 220 with integral sealing rings 222 shaped for sealing engagement with inner wall surface 224 of adapter 210.
  • Stopper 220 is attached to container 200 (or alternatively to adapter 210) by an integral strap 226. Strap 226 may have a line of weakness 228 formed close to the container, to allow the stopper 220 to be detached from the container or adapter during subsequent processing of the sample.
  • Fig. 31 shows a lateral cross-sectional view along lines H-H 1 in Fig. 30.
  • Aperture 210 has a rigid diaphragm portion 230 extending perpendicularly away from inner wall 224.
  • Diaphragm portion 230 has an elongate slot 232 formed in it which, when the adapter 210 is fitted on the container 200, defines an aperture between the internal space of the container and the outside world.
  • Slot 232 is shaped and sized to allow the swab head 14 through in one rotational position, but not at another rotational position (e.g. perpendicular to the first rotational position) .
  • the operation of this embodiment is shown in Figs.
  • swab 10 has been inserted into the container 200 via slot 232 in adapter 210. This has been achieved by inserting the swab head into the container (in the direction of arrow X) in the first rotational position, namely with the broad faces of the swab head being parallel to the axis of insertion into the container and perpendicular to the plane of the paper. Subsequently, the swab handle is rotated by 90° in the direction of arrow Y. This gives the arrangement shown in Fig. 33. Here, the broad face 15 of the swab head is parallel with the plane of the paper.
  • the user moves the swab handle in direction Z.
  • the shape of the slot 232 is such that the handle 12 of the swab is able to move up and down in slot 232.
  • the swab head 14 is not able to pass through slot 232. Due to the rigid nature of diaphragm 230, and due to its strength, the swab head 14 is detached from handle 12 by further upwards movement of the swab handle relative to the adapter 210 in direction Z.
  • the handle may then be removed from the container and disposed of.
  • the stopper 220 may then be used to seal the container by sealing engagement of the rings 222 with internal wall 224 of adapter 210.
  • the stopper 220 has a broad removal flange 234, this is to facilitate removal of the stopper during subsequent processing of the sample, for example in a laboratory. At that stage, the stopper 220 may be removed from the container. If desired, strap 226 may be broken at line of weakness 228, and stopper 220 may be disposed of.
  • Figs. 30 to 34 is particularly suited to small-volume containers, for example 0.25 ml volume containers. It is intended that adapter 210 is not removed from the container 200 during subsequent processing of the sample. For this reason, slot 232 should be of suitable size to allow a probe to pass into the container in order to introduce or remove reagent, sample or processed sample 2/ from the container .
  • Figs. 35 and 36 both show schematic longitudinal cross-sectional views of another embodiment of the invention.
  • This embodiment is particularly suited to larger-volume containers than the previous embodiment.
  • this embodiment is suitable for containers of volume of about 1 ml.
  • This embodiment may be considered a modification of the embodiment shown in Fig. 12.
  • the swab head has a stopper 250 slidably located on handle 12.
  • the stopper 250 includes an aperture 252 extending therethrough, shaped to allow a snug fit around handle 12, allowing sliding with respect to handle 12, but not to allow swab head 14 to pass along aperture 252. With stopper 250 located on the handle 12, the swab is used by a subject to take a sample of buccal cells.
  • the swab head is placed in container 256 and the outer surface 258 of stopper 250 is engaged with inner surface 260 of container 256. These surfaces typically sealingly engage with each other. Then, the user pulls handle 12 out of the container, engaging swab head 14 with bottom surface 254 of stopper 250. Further upwards movement of handle 12 causes swab head 14 to become detached from handle 12 by abutment with surface 254.
  • lid 262 may be used to seal the container.
  • Lid 262 may be formed from rubber, or it may be a more rigid material. For example, it may cooperate with a screw thread 264 formed on the outer surface of container 256.
  • lid 262 may have a strap 266 which attaches it to container 256. Strap 266 may include a line of weakness 268. During subsequent processing of the sample, lid 262 may be removed from the container, and, if desired, strap 266 may be broken at line of weakness 268 to remove lid 262 completely from the kit. The lid may then be disposed of, if desired.
  • Figs. 18-20 illustrate modifications of the swab structure, in particular modifications of the size and shape of the projecting connection elements 20.
  • the connection elements 20 are directed to curve upwardly from the tongue 18 with respect to the swab head. This can assist in breaking the swab head segments apart when the tongue 18 moves downwardly with respect to the swab head 14.
  • the connection elements 20 are directed to curve upwardly from the tongue 18. This can assist in breaking the swab head segments apart when the tongue 18 moves upwardly with respect to the swab head 14.
  • Fig. 18-20 illustrate modifications of the swab structure, in particular modifications of the size and shape of the projecting connection elements 20.
  • the connection elements 20 are directed to curve upwardly from the tongue 18 with respect to the swab head. This can assist in breaking the swab head segments apart when the tongue 18 moves upwardly with respect to the swab head 14.
  • connection elements 20 are enlarged compared to the connection elements of the embodiment illustrated by Fig. 18. This can provide extra stiffness to the swab head as a whole and also can assist in breaking the swab head segments apart during movement of the tongue 18 with respect to the swab head.
  • the kit includes a swab 10, a sleeve of paper 80 and a container 82.
  • the sleeve of paper 80 is shaped and sized to fit snugly around the swab head 14.
  • the paper is absorbent, typically absorbing water and/or aqueous solutions.
  • the snug fit allows sample held by the swab to be transferred (e.g. by leaching) from the swab to the paper sleeve 80. This is enhanced by the fact that polypropylene (the material of the swab) is non-absorbent.
  • the combination is placed into the container 82 for storage.
  • the container may be a container, e.g. similar to one of the containers illustrated and described with respect to Figs. 1-8 or Figs. 9 and 10 or Figs. 11-16.
  • the sleeve is first fitted within the container 82 before the swab head is located within the sleeve.
  • An advantage of this is that the sleeve need only be handled by way of the outside surface of the container. This can avoid contamination problems.
  • the sleeve is a snug fit within the container 82. In this way, the sleeve can be pressed between the swab head 14 and the inside surface 84 of the container 82. This can assist in the efficient transfer of sample from the swab head 14 to the sleeve 80.
  • Fig. 22 illustrates an embodiment of a modified container for use, e.g. with the kit arrangement of Figs. 1-8.
  • a container 86 of a similar shape to the container 30 of Fig. 1 is shown.
  • a partial lining 88 of absorbent material is located on the inside surface of the container 86.
  • the lining 88 is located at or close to the final location of a detached (and split) swab head in the container 86 after use of the kit.
  • Use of a tapering container means that the swab head 14 is detached from the shaft 12 due to pressure between the inner surface of the container 86. Since the inner surface of the container is lined with the absorbent lining, the swab head is pressed against this lining.
  • the absorbent material used in these embodiments is typically an impregnated sample collection paper, e.g. a treated filter paper.
  • the sample is typically collected from the swab head onto the paper and allowed to dry.
  • the treated paper can yield high quality nucleic acid for PCR amplification.
  • the treatment of the paper allows the paper to disrupt intact cells and release nucleic acids from nucleated cells in blood, eukaryotic cells, bacteria or virus particles. After drying, the sample can be rehydrated and then amplifiable nucleic acids can be eluted from the paper.
  • DNA for example can be amplified from the paper itself.
  • the paper is treated in such a way that substances which inhibit PCR reactions (e.g. haemoglobin in blood samples) become fixed to the matrix of the paper and are not released with template nucleic acids.
  • Suitable material is available in the form of modified filter paper called IsoCodeTM (e.g. catalogue no. 495020, 495000, 495005, 495015, 495017, 495025), available from Schleicher & Schuell, P.O. Box 4, D-37582 Dassel, Germany or Keene, NH 03431, USA.
  • IsoCodeTM e.g. catalogue no. 495020, 495000, 495005, 495015, 495017, 495025
  • Schleicher & Schuell P.O. Box 4, D-37582 Dassel, Germany or Keene, NH 03431, USA.
  • the content of US patent numbers 5939259, 6168922, 5807527 is incorporated herein by reference.
  • Use of the treated absorbent paper in the container allows the paper to process (i.e. commence nucleic acid release) from the sample transferred to it from the swab head during shipment of the sample. This can greatly reduce the time taken to process the sample and can remove yet another step from the processing of the sample which could otherwise give rise to a risk of contamination.
  • Use of the swab described provides a high yield of biological material due to the non-absorbent nature of the swab head material, and also due to the large surface area of the swab head and its rigid surface (which makes it relatively abrasive) .
  • the absorbent paper can allow longer term storage of the sample at room temperature.

Abstract

L'invention concerne des kits d'échantillonnages et des dispositifs d'échantillonnage ainsi que leurs utilisations. L'invention concerne un kit d'échantillonnage comprenant un tampon (10) doté d'une poignée (12) et d'une tête de tampon (14). Ledit kit comprend un récipient (30) pourvu d'un orifice éventuel (70). Ladite tête d'échantillonnage (14) peut être détachée de la poignée (12) grâce à l'enclenchement de la tête d'échantillonnage au moyen de dispositifs d'enclenchement et au déplacement de la poignée par rapport auxdits dispositifs d'enclenchement. Lesdits dispositifs d'enclenchement peuvent être formés sur l'orifice ou sur le récipient. Après détachement de la tête d'échantillonnage de la poignée, ladite tête d'échantillonnage reste dans le récipient. Ledit récipient peut être fermé hermétiquement au moyen de dispositifs de fermeture hermétique (220). L'invention concerne également un kit d'échantillonnage contenant des dispositifs de traitement qui permettent de procéder au traitement d'un échantillon collecté. Le moyen de traitement utilisé est un moyen de fermeture absorbant (88) qui permet à l'échantillon d'être maintenu par la tête d'échantillonnage lors du transfert vers les dispositifs de fermeture. En particulier, la matière absorbante peut être un papier imprégné pouvant produire des acides nucléiques amplifiables à partir de cellules buccales.
PCT/GB2003/002800 2002-06-28 2003-06-27 Kits d'echantillonnage, dispositifs et procedes d'utilisations associes WO2004003515A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US10/519,147 US20050252820A1 (en) 2002-06-28 2003-06-27 Sampling kits, devices and uses thereof
AU2003236925A AU2003236925A1 (en) 2002-06-28 2003-06-27 Sampling kits, devices and uses thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0215044.9 2002-06-28
GBGB0215044.9A GB0215044D0 (en) 2002-06-28 2002-06-28 Sampling kits, devices and uses thereof

Publications (2)

Publication Number Publication Date
WO2004003515A2 true WO2004003515A2 (fr) 2004-01-08
WO2004003515A3 WO2004003515A3 (fr) 2004-02-19

Family

ID=9939516

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2003/002800 WO2004003515A2 (fr) 2002-06-28 2003-06-27 Kits d'echantillonnage, dispositifs et procedes d'utilisations associes

Country Status (4)

Country Link
US (1) US20050252820A1 (fr)
AU (1) AU2003236925A1 (fr)
GB (1) GB0215044D0 (fr)
WO (1) WO2004003515A2 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1712180A1 (fr) * 2005-04-11 2006-10-18 Enomoto Co., Ltd. Ensemble de collecte de sang
US7745204B1 (en) 2005-04-29 2010-06-29 Georgia Tech Research Corporation Automation of biological sample aliquoting
US8318488B1 (en) 2004-05-11 2012-11-27 Axiogenesis Ag Assay for drug discovery based on in vitro differentiated cells
WO2013021376A1 (fr) * 2011-08-07 2013-02-14 Hadayer Amir Injecteur d'échantillon stérile et procédé correspondant
GB2538088B (en) * 2015-05-06 2019-01-16 Caldbeck Overseas Ltd Clinical sampling device
CN110074820A (zh) * 2012-11-20 2019-08-02 纽约哥伦比亚大学董事会 医疗设备以及用于收集生物样本的方法
WO2020260583A1 (fr) 2019-06-28 2020-12-30 Universiteit Gent Dispositif d'échantillonnage pour échantillons biologiques

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8075850B2 (en) * 2006-01-13 2011-12-13 The Bode Technology Group, Inc. Touch evidence collection apparatus and method
US9052254B2 (en) 2006-01-13 2015-06-09 The Bode Technology Group, Inc. Evidence collector with integral quantified reagents and method of modulating specimen drying time
US7915032B2 (en) * 2006-03-03 2011-03-29 Capitol Vial Inc. Sample collection system and method
EP2007651A4 (fr) * 2006-04-14 2012-09-05 Bode Technology Group Inc Dispositif de prélèvement d'échantillon basse pression
WO2009012307A2 (fr) * 2007-07-16 2009-01-22 Forensic Id, Llc Dispositif de collecte de spécimens et procédé d'utilisation
US7854895B2 (en) * 2008-02-13 2010-12-21 Capitol Vial Inc. Fluid sample collection system and method
US7850922B2 (en) * 2008-02-13 2010-12-14 Capitol Vial Inc. Fluid sample collection system
DE202008013218U1 (de) * 2008-10-04 2009-01-15 Schmiedl, Dieter, Dr. Probenträger für die Sicherung von mikrobiologischen, virologischen, genetischen, medizinischen, veterinärmedizinischen, forensischen, kriminaltechnischen und technischen Spuren
DE202008013219U1 (de) * 2008-10-04 2008-12-18 Schmiedl, Dieter, Dr. Forensische Pipette zum Befeuchten und Handhaben von Probenträgern auf Basis einer Mikroliterpipettenspitze
DE202008017181U1 (de) * 2008-12-30 2009-03-26 Schmiedl, Dieter, Dr. Aliquotiereinrichtung
DE202009001433U1 (de) * 2009-02-05 2009-04-09 Schmiedl, Dieter, Dr. Asservierungsbehälter
DE102010062064A1 (de) * 2010-11-26 2012-05-31 Hamilton Bonaduz Ag Probenbehälter zur Aufbewahrung und Verarbeitung von mit einem Probenentnahmewerkzeug entnommenen Proben
WO2012145379A1 (fr) 2011-04-19 2012-10-26 Porex Corporation Dispositif d'échantillonnage, de stockage, de transfert et de distribution de liquide
EP2583627A1 (fr) * 2011-10-21 2013-04-24 Vibod GmbH Dispositif de collecte légale
US20130116597A1 (en) 2011-11-04 2013-05-09 Phenomenex, Inc. Method and apparatus for acquiring blood for testing
FI20155110L (fi) * 2015-02-19 2016-08-20 Thermo Fisher Scientific Oy Näytteenotin ja näytteenottimen ja näyteastian yhdistelmä
US10071381B2 (en) 2015-04-17 2018-09-11 Neoteryx, Llc. Method and apparatus for handling blood for testing
US10299767B2 (en) 2015-05-20 2019-05-28 Alpha-Tec Systems, Inc. Sample collection apparatus
NZ720675A (en) * 2016-05-31 2017-07-28 Crime Scene Solutions Ltd Improved collection and storage apparatus
CN107663503A (zh) * 2016-07-28 2018-02-06 上海凝阔科技有限公司 一种pcr扩增容器及pcr扩增方法
KR101953884B1 (ko) 2016-11-04 2019-03-04 한국식품연구원 병원성 박테리아의 신속 간편 육안 진단을 위한 페이퍼 기반 비색 센서 키트 및 이를 이용한 병원성 박테리아의 신속 간편 육안 검출방법
JP7245816B2 (ja) * 2017-07-13 2023-03-24 エリューム リミテッド サンプル収集デバイス
CN107928712A (zh) * 2017-12-29 2018-04-20 张罗 取样棉拭子及无菌采样套组
US11207677B2 (en) 2018-03-07 2021-12-28 University Of Virginia Patent Foundation Devices, systems, and methods for detecting substances
US20200289098A1 (en) * 2019-03-15 2020-09-17 Orig3N, Inc. Dna collection device
CN111588414B (zh) * 2020-05-22 2022-05-13 珠海市人民医院 叉分避空多头取样棒
WO2021237293A1 (fr) * 2020-05-27 2021-12-02 3DMEDiTech Pty Ltd Écouvillon
JP6931839B1 (ja) * 2020-08-07 2021-09-08 株式会社臨床検査器材 検体採取キット
CN114486759A (zh) * 2022-01-24 2022-05-13 浙江省农业科学院 一种饲料中生物毒素检测装置
WO2023192673A1 (fr) * 2022-04-01 2023-10-05 Rhinostics Inc. Dispositifs de collecte conçus pour une interaction avec un équipement automatisé et procédés associés

Citations (9)

* 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
US4175008A (en) * 1978-06-26 1979-11-20 Bio-Pharmaceutical Packaging Corp. Culture specimen collection and transport package
EP0420450A1 (fr) * 1989-09-18 1991-04-03 Bionor A/S Appareil pour la récolte et le transport de micro-organismes
US5335673A (en) * 1989-09-21 1994-08-09 Epitope, Inc. Oral collection device and method for immunoassay
EP0734684A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
US5714341A (en) * 1994-03-30 1998-02-03 Epitope, Inc. Saliva assay method and device
US5830154A (en) * 1996-01-11 1998-11-03 Epitope, Inc. Device for collecting substances for testing
WO2002006791A2 (fr) * 2000-07-13 2002-01-24 International Bioproducts Incorporated Dispositif d'echantillonnage a tete separable et procede d'utilisation
WO2003028889A1 (fr) * 2001-09-28 2003-04-10 Orasure Technologies, Inc. Collecteur d'echantillons et dispositif d'essai

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5807527A (en) * 1991-05-29 1998-09-15 Flinders Technologies Pty. Ltd. Solid medium and method for DNA storage
US5939259A (en) * 1997-04-09 1999-08-17 Schleicher & Schuell, Inc. Methods and devices for collecting and storing clinical samples for genetic analysis

Patent Citations (9)

* 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
US4175008A (en) * 1978-06-26 1979-11-20 Bio-Pharmaceutical Packaging Corp. Culture specimen collection and transport package
EP0420450A1 (fr) * 1989-09-18 1991-04-03 Bionor A/S Appareil pour la récolte et le transport de micro-organismes
US5335673A (en) * 1989-09-21 1994-08-09 Epitope, Inc. Oral collection device and method for immunoassay
US5714341A (en) * 1994-03-30 1998-02-03 Epitope, Inc. Saliva assay method and device
EP0734684A1 (fr) * 1995-03-30 1996-10-02 Ortho Pharmaceutical Corporation Dispositif domestique de prélèvement d'un échantillon de fluide oral et son emballage postal
US5830154A (en) * 1996-01-11 1998-11-03 Epitope, Inc. Device for collecting substances for testing
WO2002006791A2 (fr) * 2000-07-13 2002-01-24 International Bioproducts Incorporated Dispositif d'echantillonnage a tete separable et procede d'utilisation
WO2003028889A1 (fr) * 2001-09-28 2003-04-10 Orasure Technologies, Inc. Collecteur d'echantillons et dispositif d'essai

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8318488B1 (en) 2004-05-11 2012-11-27 Axiogenesis Ag Assay for drug discovery based on in vitro differentiated cells
EP1712180A1 (fr) * 2005-04-11 2006-10-18 Enomoto Co., Ltd. Ensemble de collecte de sang
US7745204B1 (en) 2005-04-29 2010-06-29 Georgia Tech Research Corporation Automation of biological sample aliquoting
WO2013021376A1 (fr) * 2011-08-07 2013-02-14 Hadayer Amir Injecteur d'échantillon stérile et procédé correspondant
US9921138B2 (en) 2011-08-07 2018-03-20 Mor Research Applications Ltd. Sterile sample injector and method
CN110074820A (zh) * 2012-11-20 2019-08-02 纽约哥伦比亚大学董事会 医疗设备以及用于收集生物样本的方法
GB2538088B (en) * 2015-05-06 2019-01-16 Caldbeck Overseas Ltd Clinical sampling device
WO2020260583A1 (fr) 2019-06-28 2020-12-30 Universiteit Gent Dispositif d'échantillonnage pour échantillons biologiques

Also Published As

Publication number Publication date
AU2003236925A8 (en) 2004-01-19
GB0215044D0 (en) 2002-08-07
US20050252820A1 (en) 2005-11-17
AU2003236925A1 (en) 2004-01-19
WO2004003515A3 (fr) 2004-02-19

Similar Documents

Publication Publication Date Title
US20050252820A1 (en) Sampling kits, devices and uses thereof
US7141033B2 (en) Sample collection device and method
US9072499B2 (en) Sample collection tool
RU2729113C2 (ru) Система и способ сбора образца нуклеиновой кислоты
WO2005032377A1 (fr) Trousse d'echantillonnage biologique contenant un agent antimicrobien, et utilisations de la trousse
US20100111773A1 (en) Apparatus and method for recovering fluid from a fluid absorbing element
EP2223656B1 (fr) Tube de test amélioré pour collecter, transporter et extraire des échantillons fécaux
JP5547235B2 (ja) 試料破砕器具および試料破砕回収器具
EP2537016A2 (fr) Système de collecte d'échantillons biologiques
US20200399577A1 (en) Sampling device and combination of sampling device and sample vessel
US9588133B2 (en) Analytical system with tip rack assembly configured to prevent contamination
US20080139962A1 (en) Analyte Collection Apparatus and Method
US20090171245A1 (en) Swab extraction device and methods of using
JP2020008464A (ja) 回収容器及び回収デバイス
AU739199B2 (en) Collection container assembly
AU747043B2 (en) Collection container assembly
US10473566B2 (en) Blood sampling, storage and treatment apparatus
CN219044930U (zh) 核酸提取装置
JP7231211B2 (ja) 拭き取り検査用キット
EP4230149A1 (fr) Dispositif de collecte d'un échantillon, kit comprenant un tel dispositif et procédé utilisant un tel dispositif ou kit
US20240156444A1 (en) Automation compatible collection device for biological samples
WO2023192673A1 (fr) Dispositifs de collecte conçus pour une interaction avec un équipement automatisé et procédés associés
WO2023154280A1 (fr) Système de collecte et de distribution d'échantillon biologique
JP2005161162A (ja) 遠心分離チューブ用アダプタ
EP2848304A1 (fr) Dispositif de préparation d'échantillons d'analyse, support, système de préparation d'échantillons d'analyse, procédé de préparation d'échantillons et procédé d'analyse d'un échantillon

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWE Wipo information: entry into national phase

Ref document number: 10519147

Country of ref document: US

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP