WO2022223121A1 - Swab tube - Google Patents
Swab tube Download PDFInfo
- Publication number
- WO2022223121A1 WO2022223121A1 PCT/EP2021/060567 EP2021060567W WO2022223121A1 WO 2022223121 A1 WO2022223121 A1 WO 2022223121A1 EP 2021060567 W EP2021060567 W EP 2021060567W WO 2022223121 A1 WO2022223121 A1 WO 2022223121A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sample tube
- cap
- sample
- rod
- hole
- Prior art date
Links
- 238000004891 communication Methods 0.000 claims abstract description 9
- 239000007788 liquid Substances 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 12
- 239000004677 Nylon Substances 0.000 claims description 2
- 239000000284 extract Substances 0.000 claims description 2
- 229920001778 nylon Polymers 0.000 claims description 2
- 239000000523 sample Substances 0.000 description 111
- 238000010828 elution Methods 0.000 description 19
- 238000012360 testing method Methods 0.000 description 14
- 238000005070 sampling Methods 0.000 description 10
- 238000005119 centrifugation Methods 0.000 description 6
- 210000003414 extremity Anatomy 0.000 description 5
- 239000000872 buffer Substances 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 210000003928 nasal cavity Anatomy 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 108020000999 Viral RNA Proteins 0.000 description 2
- 239000012472 biological sample Substances 0.000 description 2
- 210000000214 mouth Anatomy 0.000 description 2
- 239000012466 permeate Substances 0.000 description 2
- 239000012209 synthetic fiber Substances 0.000 description 2
- 229920002994 synthetic fiber Polymers 0.000 description 2
- 229920000742 Cotton Polymers 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 230000005465 channeling Effects 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000002657 fibrous material Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000012139 lysis buffer Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000001331 nose Anatomy 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 210000003800 pharynx Anatomy 0.000 description 1
- 238000006748 scratching Methods 0.000 description 1
- 230000002393 scratching effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000012780 transparent material Substances 0.000 description 1
- 210000001364 upper extremity Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
-
- 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
- B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0096—Casings for storing test samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0216—Sampling brushes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/14—Process control and prevention of errors
- B01L2200/141—Preventing contamination, tampering
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/16—Reagents, handling or storing thereof
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/02—Identification, exchange or storage of information
- B01L2300/021—Identification, e.g. bar codes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/04—Closures and closing means
- B01L2300/046—Function or devices integrated in the closure
- B01L2300/047—Additional chamber, reservoir
Definitions
- the following description relates to a tube with swab and a method for collecting and analyzing a sample using the swab tube.
- Swabs are commonly used for collecting biological samples that have to be analyzed, e.g. from the mouth, nose and throat of a subject. Once the sample has been acquired, the swab is placed in a container and transported to a lab, where an analysis is carried out.
- a device comprising a sample tube having an open end.
- the sample tube may have an aperture at one extremity.
- the sample tube may have substantially the shape of a right cylinder or right prism (e.g. hexagonal) with only one base.
- the open end of the sample tube may be a circular or polygon-shaped opening, corresponding to the cross-section of the sample tube.
- the characteristic dimension of a l two-dimensional region is a one-dimensional quantity from which the area of the two-dimensional region can be computed.
- the sample tube may have a circular cross-section and the characteristic dimension may be its diameter.
- the cross-section is a regular polygon (e.g. a square or hexagon)
- the characteristic dimension may be its diameter, i.e. the longest polygon diagonal. If it is a rectangle, the characteristic dimension may be the geometric mean of its sides.
- the characteristic dimension of the open end may be between about 6 mm and about 8 mm, in particular about 7 mm.
- the length of the sample tube (e.g. the height of the cylinder or prism) may be between about 4 cm and about 8 cm, in particular about 5 to 6 cm.
- the length of the sample tube may be determined according to the specific application of the device.
- the sample tube may be made of a transparent material, such as glass or plastic.
- the device further comprises a cap configured to close the open end of the sample tube, the cap comprising a through-hole.
- the cap is configured to at least partially close the open end of the sample tube.
- the through-hole can, in turn, be sealed with a film or a rubber seal. When needed (e.g. to introduce a buffer), the film can be pulled off or be perforated, while the rubber seal may be removable.
- the cap may be configured to be releasably fixed to the sample tube at its open end.
- the cap may be configured to engage the sample tube so as to be positioned at its open end and to disengage the sample tube so as to be removed from its open end.
- the cap and the sample tube may comprise complementary features configured to engage with each other.
- the cap may comprise an external or male thread and the sample tube may comprise an internal or female thread, or vice versa.
- the connection between the cap and the sample tube may be a plug-like connection.
- the cap may be screwed to or plugged into the sample tube automatically, e.g. by a robot.
- the cap may be made of plastic.
- the cap comprises a through-hole.
- the through-hole may extend from a side of the cap configured to be facing the inside of the sample tube to a side of the cap configured to be facing the external environment.
- the through-hole may be configured such that, when the cap is mounted on the sample tube, the through-hole provides (the only) access to the inside of the tube (more specifically to a rod inside the sample tube, as will be explained below). Accordingly, by means of the cap, the aperture of the open end of the sample tube is reduced to the trough-hole (which may be sealed, as explained above).
- the through-hole may comprise at least a receiving portion configured to receive a rod, as discussed below.
- the (receiving portion of the) through-hole may have the shape of a right cylinder or a right prism.
- the through-hole may be characterized by its height, i.e. the height of the cap, and its cross-section perpendicular to the height. Considering the ideal plane defined by the open end of the tube (i.e. the plane containing the rim of the tube), the height of the through-hole may be perpendicular to this ideal plane.
- the cross section of (the receiving portion of) the through-hole may be smaller than the open end.
- the cross-section may have a characteristic dimension between about 3 mm and about 4 mm, in particular about 3.6 mm.
- the height of the receiving portion of the through-hole may be between about 0.5 cm and about 1 cm.
- the height of the cap and, thus, of the whole through-hole may be between about 1 cm and about 3 cm, e.g. about 2 cm.
- the cap may comprise a main body having e.g. a cylindrical or prismatic shape and an engaging part configured to engage the sample tube, e.g. the thread discussed above.
- the main body may facilitate holding the cap, e.g. when the cap is used as handle for the rod and swab tip discussed below.
- the main body of the cap (and/or the rubber seal, if present), may comprise a feature, such as a recess, configured to be engaged by a tool, e.g. a tool for automatically placing and/or removing the cap.
- the main body may have substantially the same cross-section as the sample tube and may have a height between about 0.5 cm and about 1 cm.
- the engaging part may substantially have the same cross-section as the interior of the sample tube, if it the engaging part is configured to be inserted in the sample tube (e.g. it is a male thread).
- the receiving portion of the through-hole may be formed in the engaging part (and possibly also in the main body). If the engaging part is configured to engage the outer surface of the sample tube (e.g. it is a female thread), the through-hole portion within the engaging part may substantially have the same cross-section as the sample tube. In this case, the receiving portion of the through-hole may be formed only in the main body.
- the through-hole may comprise only the receiving portion. In other words, the whole length of the through-hole is occupied by the rod. In other examples, the through-hole may comprise other portions beyond the receiving portion, wherein the other portions may have a cross-section with a characteristic dimension different from the one of the receiving portion. The rod may not be inserted in the other portions of the through-hole.
- the through-hole may comprise at least a cap portion positioned in the cap having a larger characteristic dimension (e.g. between about 5 mm and 7 mm) than the one of the receiving portion.
- the main body may be substantially hollow, e.g. be a hollow cylinder or prism, meaning that the through-hole has thin walls (e.g. 1 mm thickness)
- a hollow main body, i.e. a larger characteristic dimension of the cap portion may facilitate the injection of a liquid in the through-hole.
- the liquid may be poured in the hollow main body and, from there, it may descend through the rest of the through-hole, e.g. during centrifugation of the tube.
- the cross-section of the cap portion of the through-hole may be constant along the height of the cap or may vary, e.g. the cap portion may be tapered or stepped.
- the through-hole may comprise other portions between the cap portion and the receiving portion, e.g. a narrow portion having a cross-section with characteristic dimension smaller than the one of the receiving portion. This characteristic dimension may correspond to the one of a cavity of the rod, which is described below.
- the narrow portion and the receiving portion may be located in the engaging part of the cap.
- the device further comprises a rod comprising a cavity, the rod being connected to the cap such that the cavity is in communication with the through-hole.
- the rod may be an elongated, straight component, e.g.
- the rod is hollow and the cavity may run throughout the length of the rod.
- the cavity may have a cylindrical shape or a prism shape as well.
- the cross-section of the rod perpendicular to its length may have a characteristic dimension between about 3 mm and about 4 mm, in particular about 3.6 mm and the cross-section of the cavity within may have a characteristic dimension between about 1.5 mm and about 4 mm, in particular about 2.5 mm, the difference due to the thickness of the wall of the rod.
- the material of the rod may be plastic.
- the rod may be connected to the cap by being partially inserted in (the receiving portion of) the through-hole, e.g. being inserted for at least 10% of the rod’s length, in particular at least 20%, within the through-hole and, thus, inside the cap.
- the size and shape of the cross-section of the rod may match the cross- section of (the receiving portion of) the through-hole, so that the rod fits tightly in the through-hole and is, thus, securely connected to the cap.
- the through- hole may be placed within the rod.
- the through-hole may comprise an inserting portion.
- the through-hole may be formed in the cap such that a part (e.g. an end part) of the through-hole is defined by a protruding (e.g. tubular) portion.
- the cap may comprise a (protruding) portion configured to be inserted inside the cavity of the rod, the portion of the cap comprising at least part of the through-hole.
- the length of the portion may be at least 10%, in particular at least 20%, of the length of the rod.
- the cross-section of the cavity may match the cross-section of the protruding portion.
- the cavity Independently from the specific way in which the rod is connected to the cap, the cavity is in communication with the through-hole. This means that if something is introduced in the through-hole, it can reach the cavity from the through-hole. For example, a liquid may flow from the through-hole into the cavity.
- the device further comprises a swab tip connected to the rod such that the swab tip is in communication with the cavity.
- the rod may comprise two ends and may be connected to the cap at one end and to the swab tip at the opposite end.
- the swab tip may be made of a permeable material (such as a fibrous material or a solid material) , e.g. a synthetic fiber or a non-synthetic fiber like cotton.
- the swab tip may be coated with flocked nylon.
- the swab tip may comprise a connecting portion and a sampling portion.
- the connecting portion may be configured to be inserted into the cavity of the rod. Accordingly, the connecting portion may have a shape and a cross-section corresponding to those of the cavity, e.g. it may be cylindrical.
- the length of the connecting portion may be at least 10%, in particular at least 20%, of the length of the rod (and, thus, of the cavity).
- the connecting portion may comprise one or more protrusions, e.g. in the shape of rings around the main cylindrical body, that may make the connection with the rod more secure, i.e. may prevent an accidental detachment of the swab tip.
- the material of the swab tip may be compressible.
- the sampling portion may be configured to collect the sample.
- the sampling portion may have a shape and dimensions that make it suitable for being inserted in a body cavity such as a nasal cavity or oral cavity and for retrieving sufficient amount of the sample once in place, e.g. by smearing.
- the sampling portion may have e.g. an ovoidal shape.
- the sampling portion may protrude from the rod.
- the distance between the extremity of the swab tip in contact with the rod and the opposite extremity (i.e. the farthest point from the rod) may be between about 1 cm and about 2 cm.
- the swab tip is in communication with the cavity.
- a liquid may flow through the cavity and reach the swab tip. If the swab tip is made from a permeable material, the liquid may permeate the swab tip. Since the cavity is also in communication with the through-hole, there is a channel between the through-hole and the swab tip.
- the swab tip is connected to the rod which is, in turn, connected to the cap.
- the rod and the swab tip are configured to be positioned within the sample tube.
- the rod and the swab tip are joined on the side of the cap that engages the sample tube. Therefore, once the swab tip is inside the sample tube, the through-hole is the only inlet to the swab tip.
- the combination of cap, rod and swab tip may be referred to as “sampling-elution element” and has multiple functions.
- the sampling-elution element can be used by a user, e.g. a doctor, to collect a sample from a subject, e.g. a patient: the sampling- elution element can be held from the cap and the swab tip can be smeared against a body cavity to gather some biological material. Once the sample has been collected, the sampling-elution element can be used to seal the sample tube and to allow a liquid to come into contact with the sample for eluting a target item.
- the sample tube is open at one end (the upper end).
- the sample tube comprises a bottom part opposite the open end.
- the bottom part may comprise a closure for the sample tube, i.e. a floor, and the lowest part of the wall of the tube, e.g. extending about 5% of the length of the tube.
- the floor may be located at the (lower) end of the sample tube, e.g. it may be the bottom base of a cylindrical sample tube.
- the floor may be positioned at a distance from the lower end of the sample tube, wherein the distance may be e.g. about 5% of the length of the tube.
- the bottom part may have a step portion in which the size of the cross section of the sample tube gets narrower.
- the bottom part may be U-shaped or V- shaped.
- the distance between the swab tip and the floor of the sample tube i.e. the height of the portion of the sample tube in which the target item will be collected
- the distance between the swab tip and the floor of the sample tube i.e. the height of the portion of the sample tube in which the target item will be collected
- the distance between the swab tip and the floor of the sample tube i.e. the height of the portion of the sample tube in which the target item will be collected
- 1 cm and 2 cm e.g. 1.5 cm.
- the bottom part may be configured to be secured to a rack.
- Racks are used in the field of sample analysis, with each well being configured to accommodate a respective sample tube.
- each well may be a cavity and may have an aperture in the plane of the rack, through which a sample tube may be inserted.
- the sample tube may have a cross-section with a shape and a characteristic dimension corresponding to that of the well, e.g. 8 mm.
- the bottom part of the sample tube may be configured to prevent displacement (e.g. rotation) of the tube when the cap is being positioned or removed (e.g. screwed or unscrewed).
- the fact that the bottom part can be securely fixed to the rack, together with the feature in the cap for engaging a tool, may enable automatically opening/closing multiple tubes at the same time with a machine, e.g. a recapper/ decapper
- the well would have a corresponding shape, and the fit between the bottom part and the well may maintain the position of the tube with respect to the rack fixed. Indeed, the fit is in this case rotationally asymmetrical, i.e. it does not allow rotations of the tube with respect to the well.
- the bottom part may be modified to have a polygon-shaped cross-section.
- the bottom part may comprise a first locking portion (e.g. including at least one protrusion or recess) configured to engage with a second locking portion (e.g. including at least one protrusion or recess) in the rack.
- the locking portions may interlock with each other so as to securely fix the sample tube to the rack and prevent a rotation thereof.
- the bottom part of the sample tube may be automatically screwed to the rack, e.g. by a robot.
- a switchable locking mechanism may be activated to maintain the sample tubes rotationally fixed to the rack while the caps are positioned or removed.
- the device may be compatible with a 96-wells microplate having 12 columns and 8 rows.
- a 96-wells microplate is defined by the standards ANSI/SBS 1- 2004, ANSI/SBS 2-2004, ANSI/SBS 3-2004, ANSI/SBS 4-2004.
- the device may further comprise an identification code placed on the sample tube to uniquely identify the sample taken from a specific person to be tested (e.g. the user, in case of a self-test).
- the identification code can be a human-readable and/or a machine-readable code, including one or more of a bar code, a QR code, a number code, a code word, an alphanumeric code.
- the identification code can include one or more of a printed code, an embossed code, a magnetically and/or electronically stored code.
- the identification code may be a bar code and/or a QR code placed on the sample tube.
- the bar code and/or QR code may help identify the sample contained in the sample tube.
- the identification code (e.g. QR code) may be placed on the floor of the sample tube.
- the identification code may be a sealed code, which cannot be read without breaking a seal. This allows a user to confirm that a device handed out has not yet been registered individually. Specifically, as long at the seal has not been broken, the user knows that his/her device has not been individually registered in connection with the user, thereby supporting privacy of the test process. Once the device is handed out to the user, the user can privately open/break the seal and read the identification code, which can then be used for later retrieval of the test result, e.g. by entering the code into a respective web interface. Since no one could link the identification code with the person to be tested (in advance), privacy of the test can be ensured.
- the identification code can be sealed with a scratchable cover layer.
- the user can remove the cover layer by scratching it and thereby uncover the identification code.
- the user can then copy or store the identification code for later retrieval of the test result, i.e. the identification code may be used as a passcode for the test result.
- the user may keep the code secret, or make at least sure that no one can (directly) link the code with the user.
- the identification code should at least partly remain connected with the device (and thus the sample). But even in case the unsealed identification code can be read by a third party, privacy of the test result can be maintained by anonymously collecting the sample devices from many users without registering them in connection with each other.
- the identification code could be implemented as a twin-code, where the same information is coded twice and only one part, or both parts of the twin-code are sealed separately.
- One part of the twin-code may be unsealed and removed by the user, while the other part of the twin-code may stay sealed or unsealed at the device until the analysis procedure. This supports that not only the process of handing out the sample device to the user but also the process of collecting the sample from the use ensures privacy of the test result. In particular, even in case a user personally submits the sample for the test, no one can read the first part of the twin-code, which has already been removed by the user, or the second part of the twin-code, which is still sealed.
- the user may apply a special software application, e.g. running on a mobile device (such as a mobile phone), to scan the identification code.
- This software application may then be used to retrieve the test result electronically from a test laboratory.
- the software application may even register the user’s personal information in order to link this personal information with the identification code, thereby allowing registration and tracking of positive test results by medical authorities.
- the whole process ensures a high degree of privacy as well as control by and transparency for the user, while still enabling safe and prompt tracking of test results via medical authorities upon approval by the user.
- Another aspect of the present invention relates to a method for eluting a sample collected with the swab tip of the device described heretofore.
- the method comprises: placing the cap on the sample tube; injecting a liquid in the cavity of the rod via the through-hole of the cap; centrifugating the device to cause the liquid to percolate the swab tip with the collected sample, wherein the liquid extracts a target item from the sample.
- the rod and the swab tip having the collected sample on it are situated inside the sample tube.
- the sample may need to be treated with one or more substances. For example, if viral RNA has to be extracted to detect the presence of a virus (e.g. SARS-CoV2), a lysis buffer may be combined with the biological sample to break the potentially virus-infected cells.
- a virus e.g. SARS-CoV2
- a lysis buffer may be combined with the biological sample to break the potentially virus-infected cells.
- a liquid e.g. a solution
- the device is centrifuged to push the liquid towards the swab tip with the collected sample.
- the liquid can percolate the swab tip and, hence, interact with the sample.
- the liquid is configured to extract and preserve a given target item from the sample, e.g. the RNA of the cells, which is mix of a patient’s RNA and viral RNA, if present.
- a target item can be efficiently eluted from a sample thanks to the sampling-elution element, which integrates the sampling function and the elution function, the latter being fulfilled in cooperation with the sample tube, which serves as container for the target item.
- the use of the sampling-elution element requires a smaller quantity of liquid (e.g. buffer) to extract the target item in comparison to conventional apparatuses, which leads to a higher concentration of the target item and, in turn, to a higher sensitivity.
- the target item is more effectively eluted by applying the buffer “from inside out”, namely by channeling it through the rod and making it elute the target item outwards into the sample tube. The throughput time is also reduced.
- the device described heretofore is cheap and easy to produce.
- the sample tube may be secured to a rack and centrifugating the device may comprises centrifugating the rack.
- the device gets centrifuged in virtue of the fact that it is placed into a rack, which is placed in a centrifuge.
- Yet another aspect of the present invention relates to a use of the device described above for collecting a nasal swab and detecting presence of SARS-CoV2-RNA in the nasal swab.
- Figure 1 shows an example of a swab tube.
- Figure 2 shows different views of the components of an exemplary swab tube.
- Figure 3 shows an exemplary use of a swab in a nasal cavity.
- Figure 4 shows an exemplary swab tube in different phases.
- Figure 5 shows a movement of an exemplary swab tube during centrifugation.
- Figure 6 shows an exemplary sampling-elution element in a 96-well plate.
- Figure 7 shows an exemplary swab tube in a 96-well rack.
- FIG. 1 shows an example of a swab tube 100.
- the swab tube 100 comprises a cylindrical sample tube 10 having an open end 13 and a floor 15.
- the open end 13 provides access to the hollow inside of the sample tube 10 and it is a circular hole formed by the rim of the wall of the sample tube 10.
- the floor 15 is a circular surface that closes the cylindrical sample tube 10 and is located in the lower half of the sample tube 10.
- the bottom part 17 of the sample tube 10 i.e. the part of the tube wall below the floor plus the floor itself, is configured for attaching the sample tube 10 to a rack, specifically a 96-position rack 50 (as shown in Fig. 7).
- the bottom part 17 may comprise protrusions that are configured to be inserted in respective recesses of a well when screwing the swab tube 100 to the rack 50 or may have a hexagonal shape.
- the swab tube 100 further comprises a cap 22, a rod 24 and swab tip 26 connected to each other to form a sampling-elution element 20.
- Figure 2 shows different views of these components of the exemplary swab tube 100. Specifically, view A is an exploded view of the sampling-elution element 20 and view B is a cut of view A.
- the cap 22 is configured to be placed on the open end 13 of the sample tube 10, so that the sampling-elution element 20 closes the sample tube 10.
- the cap 22 comprises a main body 210 and an engaging part 230.
- the diameter of the main body 210 is substantially identical to the diameter of the sample tube 10.
- the main body 210 is a hollow cylinder and comprises part of a through-hole 220, also denoted as “cap portion” of the through-hole 220.
- the cap portion has a first sector having a first diameter and a second sector having a second diameter being smaller than the first diameter, the two sectors being joined by a tapered portion.
- the engaging part 230 is in the shape of an external thread configured to fit within the sample tube 10.
- the sample tube 10 comprises an internal thread to which the engaging part 230 can be screwed, e.g. automatically, such as by a robot.
- the part of the through-hole 220 in the engaging part 230 comprises a receiving portion 225.
- the rod 24 is connected to the cap 22 in that the upper extremity of the rod 24 is inserted in the receiving portion 225 of the through-hole 220.
- the part of the through- hole 220 in the engaging part 230 further comprises a narrow portion and a tapered portion that connects the narrow portion to the second sector of the cap portion.
- the rod 24 comprises a cavity 240 extending throughout its length and, when connecting the rod 24 to the cap 22, the cavity 240 becomes a continuation of the through-hole 220.
- the swab tip 26 is connected to the other extremity of the rod 24.
- the swab tip 26 comprises a connecting portion 250 and a sampling portion 270, wherein the connecting portion 250 is inserted in the cavity 240.
- the connecting portion 250 is a cylinder configured to fit within the cavity and it comprises a plurality of ring-shaped protrusions for press-fitting the connecting portion 250 of the swab tip 26 into the rod 24.
- the swab tube 100 may optionally comprise a rubber seal 290 configured to be placed on the cap 22 and seal the through-hole 220.
- the sampling portion 270 protrudes from the rod 24 and it is the part of the sampling- elution element 20 on which the sample is to be collected.
- a sample can be collected by smearing the sampling portion 270 of the swab tip 26 in the nasal cavity of a patient, as shown in Figure 3.
- phase I shows an exemplary swab tube 100 in different phases from storing of the sample within the sample tube 10 to obtaining a target item.
- phase II a liquid 30, like a buffer, is input in the through-hole of the sampling-elution element 20, specifically in the hollow main body 210.
- the swab tube 100 is centrifuged in order to allow the liquid to flow via the through-hole 220 through the cavity 240 (phase III), reach and permeate the swab tip 26 (phase IV), and finally percolate through the swab tip into the sample tube 10 (phase V).
- Figure 5 shows a movement of an exemplary swab tube 100 during centrifugation, wherein the liquid percolates due to the centrifugal force that arises during centrifugation.
- the target item extracted from the sample is diluted in the liquid and contained in the sample tube 10.
- the sample-elution element 20 can be inserted into one well of a 96-well microplate 40 shown in Figure 6.
- the centrifugation of the sample-elution element 20 can be carried out by centrifuging the microplate 40.
- the swab tube 100 can be inserted in one well of a 96-wells rack 50 shown in Figure 7.
- the centrifugation of the swab tube 100 can be carried out by centrifuging the rack 50.
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Abstract
Summarizing the invention, a device is provided. The device comprises a sample tube comprising an open end; a cap configured to close the open end of the sample tube, the cap comprising a through-hole; a rod comprising a cavity, the rod being connected to the cap such that the cavity is in communication with the through-hole; and a swab tip connected to the rod such that the swab tip is in communication with the cavity; wherein the rod and the swab tip are configured to be positioned within the sample tube when the open end of the sample tube is closed by the cap.
Description
Description
Technical Field
The following description relates to a tube with swab and a method for collecting and analyzing a sample using the swab tube.
Background
Swabs are commonly used for collecting biological samples that have to be analyzed, e.g. from the mouth, nose and throat of a subject. Once the sample has been acquired, the swab is placed in a container and transported to a lab, where an analysis is carried out.
Summary
It is an object of the invention to provide a sampling equipment that facilitates collection and analysis of a sample, in particular making them more efficient.
The achievement of this object in accordance with the invention is set out in the independent claims. Further developments of the invention are the subject matter of the dependent claims.
According to one aspect, a device is provided, wherein the device may also be referred to as “swab tube”. The device comprises a sample tube having an open end. In other words, the sample tube may have an aperture at one extremity. In particular, the sample tube may have substantially the shape of a right cylinder or right prism (e.g. hexagonal) with only one base.
The open end of the sample tube may be a circular or polygon-shaped opening, corresponding to the cross-section of the sample tube. The characteristic dimension of a l
two-dimensional region, such as a cross-section, is a one-dimensional quantity from which the area of the two-dimensional region can be computed. Exemplarily, the sample tube may have a circular cross-section and the characteristic dimension may be its diameter. Similarly, if the cross-section is a regular polygon (e.g. a square or hexagon), the characteristic dimension may be its diameter, i.e. the longest polygon diagonal. If it is a rectangle, the characteristic dimension may be the geometric mean of its sides.
The characteristic dimension of the open end may be between about 6 mm and about 8 mm, in particular about 7 mm. The length of the sample tube (e.g. the height of the cylinder or prism) may be between about 4 cm and about 8 cm, in particular about 5 to 6 cm. The length of the sample tube may be determined according to the specific application of the device. The sample tube may be made of a transparent material, such as glass or plastic.
The device further comprises a cap configured to close the open end of the sample tube, the cap comprising a through-hole. In particular, given the presence of the through-hole, it may be said that the cap is configured to at least partially close the open end of the sample tube. Further, in some examples, the through-hole can, in turn, be sealed with a film or a rubber seal. When needed (e.g. to introduce a buffer), the film can be pulled off or be perforated, while the rubber seal may be removable.
The cap may be configured to be releasably fixed to the sample tube at its open end. In other words, the cap may be configured to engage the sample tube so as to be positioned at its open end and to disengage the sample tube so as to be removed from its open end. In particular, the cap and the sample tube may comprise complementary features configured to engage with each other. Exemplarily, the cap may comprise an external or male thread and the sample tube may comprise an internal or female thread, or vice versa. Alternatively, the connection between the cap and the sample tube may be a plug-like connection. The cap may be screwed to or plugged into the sample tube automatically, e.g. by a robot. The cap may be made of plastic.
The cap comprises a through-hole. In particular, the through-hole may extend from a side of the cap configured to be facing the inside of the sample tube to a side of the cap configured to be facing the external environment. Said otherwise, the through-hole may be configured such that, when the cap is mounted on the sample tube, the through-hole provides (the only) access to the inside of the tube (more specifically to a rod inside the sample tube, as will be explained below). Accordingly, by means of the cap, the aperture of the open end of the sample tube is reduced to the trough-hole (which may be sealed, as explained above).
The through-hole may comprise at least a receiving portion configured to receive a rod, as discussed below. The (receiving portion of the) through-hole may have the shape of a right cylinder or a right prism. The through-hole may be characterized by its height, i.e. the height of the cap, and its cross-section perpendicular to the height. Considering the ideal plane defined by the open end of the tube (i.e. the plane containing the rim of the tube), the height of the through-hole may be perpendicular to this ideal plane.
The cross section of (the receiving portion of) the through-hole may be smaller than the open end. The cross-section may have a characteristic dimension between about 3 mm and about 4 mm, in particular about 3.6 mm. The height of the receiving portion of the through-hole may be between about 0.5 cm and about 1 cm. The height of the cap and, thus, of the whole through-hole, may be between about 1 cm and about 3 cm, e.g. about 2 cm.
The cap may comprise a main body having e.g. a cylindrical or prismatic shape and an engaging part configured to engage the sample tube, e.g. the thread discussed above. The main body may facilitate holding the cap, e.g. when the cap is used as handle for the rod and swab tip discussed below. The main body of the cap (and/or the rubber seal, if present), may comprise a feature, such as a recess, configured to be engaged by a tool, e.g. a tool for automatically placing and/or removing the cap. The main body may have substantially the same cross-section as the sample tube and may have a height between about 0.5 cm and about 1 cm.
The engaging part may substantially have the same cross-section as the interior of the sample tube, if it the engaging part is configured to be inserted in the sample tube (e.g. it is a male thread). In this case, the receiving portion of the through-hole may be formed in the engaging part (and possibly also in the main body). If the engaging part is configured to engage the outer surface of the sample tube (e.g. it is a female thread), the through-hole portion within the engaging part may substantially have the same cross-section as the sample tube. In this case, the receiving portion of the through-hole may be formed only in the main body.
In some examples, the through-hole may comprise only the receiving portion. In other words, the whole length of the through-hole is occupied by the rod. In other examples, the through-hole may comprise other portions beyond the receiving portion, wherein the other portions may have a cross-section with a characteristic dimension different from the one of the receiving portion. The rod may not be inserted in the other portions of the through-hole.
In the latter examples, the through-hole may comprise at least a cap portion positioned in the cap having a larger characteristic dimension (e.g. between about 5 mm and 7 mm) than the one of the receiving portion. In particular, the main body may be substantially hollow, e.g. be a hollow cylinder or prism, meaning that the through-hole has thin walls (e.g. 1 mm thickness) A hollow main body, i.e. a larger characteristic dimension of the cap portion, may facilitate the injection of a liquid in the through-hole. Exemplarily, the liquid may be poured in the hollow main body and, from there, it may descend through the rest of the through-hole, e.g. during centrifugation of the tube.
The cross-section of the cap portion of the through-hole may be constant along the height of the cap or may vary, e.g. the cap portion may be tapered or stepped. The through-hole may comprise other portions between the cap portion and the receiving portion, e.g. a narrow portion having a cross-section with characteristic dimension smaller than the one of the receiving portion. This characteristic dimension may correspond to the one of a cavity of the rod, which is described below. The narrow portion and the receiving portion may be located in the engaging part of the cap.
The device further comprises a rod comprising a cavity, the rod being connected to the cap such that the cavity is in communication with the through-hole. The rod may be an elongated, straight component, e.g. in the shape of a cylinder or a prism, and may have a length between about 2 cm and about 6 cm, in particular about 2.5 cm. The length may be determined based on the application of the device. The rod is hollow and the cavity may run throughout the length of the rod. Exemplarily the cavity may have a cylindrical shape or a prism shape as well.
The cross-section of the rod perpendicular to its length may have a characteristic dimension between about 3 mm and about 4 mm, in particular about 3.6 mm and the cross-section of the cavity within may have a characteristic dimension between about 1.5 mm and about 4 mm, in particular about 2.5 mm, the difference due to the thickness of the wall of the rod. The material of the rod may be plastic.
In some examples, the rod may be connected to the cap by being partially inserted in (the receiving portion of) the through-hole, e.g. being inserted for at least 10% of the rod’s length, in particular at least 20%, within the through-hole and, thus, inside the cap. In this case, the size and shape of the cross-section of the rod may match the cross- section of (the receiving portion of) the through-hole, so that the rod fits tightly in the through-hole and is, thus, securely connected to the cap.
In other examples, instead of the rod being inserted in the through-hole, the through- hole may be placed within the rod. In other words, alternatively to the through-hole comprising a receiving portion, the through-hole may comprise an inserting portion. In particular, the through-hole may be formed in the cap such that a part (e.g. an end part) of the through-hole is defined by a protruding (e.g. tubular) portion. Said otherwise, the cap may comprise a (protruding) portion configured to be inserted inside the cavity of the rod, the portion of the cap comprising at least part of the through-hole. The length of the portion may be at least 10%, in particular at least 20%, of the length of the rod. In this case, the cross-section of the cavity may match the cross-section of the protruding portion.
Independently from the specific way in which the rod is connected to the cap, the cavity is in communication with the through-hole. This means that if something is introduced in the through-hole, it can reach the cavity from the through-hole. For example, a liquid may flow from the through-hole into the cavity.
The device further comprises a swab tip connected to the rod such that the swab tip is in communication with the cavity. In particular, the rod may comprise two ends and may be connected to the cap at one end and to the swab tip at the opposite end. The swab tip may be made of a permeable material (such as a fibrous material or a solid material) , e.g. a synthetic fiber or a non-synthetic fiber like cotton. Exemplarily, the swab tip may be coated with flocked nylon.
The swab tip may comprise a connecting portion and a sampling portion. The connecting portion may be configured to be inserted into the cavity of the rod. Accordingly, the connecting portion may have a shape and a cross-section corresponding to those of the cavity, e.g. it may be cylindrical. The length of the connecting portion may be at least 10%, in particular at least 20%, of the length of the rod (and, thus, of the cavity).
Exemplarily, the connecting portion may comprise one or more protrusions, e.g. in the shape of rings around the main cylindrical body, that may make the connection with the rod more secure, i.e. may prevent an accidental detachment of the swab tip. The material of the swab tip may be compressible.
The sampling portion may be configured to collect the sample. Exemplarily, the sampling portion may have a shape and dimensions that make it suitable for being inserted in a body cavity such as a nasal cavity or oral cavity and for retrieving sufficient amount of the sample once in place, e.g. by smearing. The sampling portion may have e.g. an ovoidal shape. When the swab tip is joined to the rod, the sampling portion may protrude from the rod. The distance between the extremity of the swab tip in contact with the rod and the opposite extremity (i.e. the farthest point from the rod) may be between about 1 cm and about 2 cm.
The swab tip is in communication with the cavity. This means that it is possible to reach the swab tip from the cavity. For example, a liquid may flow through the cavity and reach the swab tip. If the swab tip is made from a permeable material, the liquid may permeate the swab tip. Since the cavity is also in communication with the through-hole, there is a channel between the through-hole and the swab tip.
Summarizing, the swab tip is connected to the rod which is, in turn, connected to the cap. When the open end of the sample tube is closed by the cap, i.e. when the cap is mounted on the open end, the rod and the swab tip are configured to be positioned within the sample tube. In other words, the rod and the swab tip are joined on the side of the cap that engages the sample tube. Therefore, once the swab tip is inside the sample tube, the through-hole is the only inlet to the swab tip.
The combination of cap, rod and swab tip may be referred to as “sampling-elution element” and has multiple functions. The sampling-elution element can be used by a user, e.g. a doctor, to collect a sample from a subject, e.g. a patient: the sampling- elution element can be held from the cap and the swab tip can be smeared against a body cavity to gather some biological material. Once the sample has been collected, the sampling-elution element can be used to seal the sample tube and to allow a liquid to come into contact with the sample for eluting a target item.
As mentioned above, the sample tube is open at one end (the upper end). The sample tube comprises a bottom part opposite the open end. The bottom part may comprise a closure for the sample tube, i.e. a floor, and the lowest part of the wall of the tube, e.g. extending about 5% of the length of the tube. In some examples, the floor may be located at the (lower) end of the sample tube, e.g. it may be the bottom base of a cylindrical sample tube. In other examples, the floor may be positioned at a distance from the lower end of the sample tube, wherein the distance may be e.g. about 5% of the length of the tube. The bottom part may have a step portion in which the size of the cross section of the sample tube gets narrower. The bottom part may be U-shaped or V- shaped.
When the sampling-elution element is fixed (e.g. screwed) to the sample tube, the distance between the swab tip and the floor of the sample tube (i.e. the height of the portion of the sample tube in which the target item will be collected) may be between 1 cm and 2 cm, e.g. 1.5 cm.
In a particular example, the bottom part may be configured to be secured to a rack. Racks are used in the field of sample analysis, with each well being configured to accommodate a respective sample tube. In particular, each well may be a cavity and may have an aperture in the plane of the rack, through which a sample tube may be inserted. Accordingly, the sample tube may have a cross-section with a shape and a characteristic dimension corresponding to that of the well, e.g. 8 mm.
The bottom part of the sample tube may be configured to prevent displacement (e.g. rotation) of the tube when the cap is being positioned or removed (e.g. screwed or unscrewed). The fact that the bottom part can be securely fixed to the rack, together with the feature in the cap for engaging a tool, may enable automatically opening/closing multiple tubes at the same time with a machine, e.g. a recapper/ decapper
In a case in which the sample tube is a prism, the well would have a corresponding shape, and the fit between the bottom part and the well may maintain the position of the tube with respect to the rack fixed. Indeed, the fit is in this case rotationally asymmetrical, i.e. it does not allow rotations of the tube with respect to the well.
In a case in which the sample tube is cylindrical, the bottom part may be modified to have a polygon-shaped cross-section. Otherwise, if the bottom part is also cylindrical, it may comprise a first locking portion (e.g. including at least one protrusion or recess) configured to engage with a second locking portion (e.g. including at least one protrusion or recess) in the rack. The locking portions may interlock with each other so as to securely fix the sample tube to the rack and prevent a rotation thereof. In particular, the bottom part of the sample tube may be automatically screwed to the rack, e.g. by a robot.
Alternatively, a switchable locking mechanism may be activated to maintain the sample tubes rotationally fixed to the rack while the caps are positioned or removed.
Exemplarily, the device may be compatible with a 96-wells microplate having 12 columns and 8 rows. A 96-wells microplate is defined by the standards ANSI/SBS 1- 2004, ANSI/SBS 2-2004, ANSI/SBS 3-2004, ANSI/SBS 4-2004.
In one example the device may further comprise an identification code placed on the sample tube to uniquely identify the sample taken from a specific person to be tested (e.g. the user, in case of a self-test). The identification code can be a human-readable and/or a machine-readable code, including one or more of a bar code, a QR code, a number code, a code word, an alphanumeric code. Moreover, the identification code can include one or more of a printed code, an embossed code, a magnetically and/or electronically stored code. In a particular example, the identification code may be a bar code and/or a QR code placed on the sample tube. The bar code and/or QR code may help identify the sample contained in the sample tube. In particular, the identification code (e.g. QR code) may be placed on the floor of the sample tube.
In a specific example, the identification code may be a sealed code, which cannot be read without breaking a seal. This allows a user to confirm that a device handed out has not yet been registered individually. Specifically, as long at the seal has not been broken, the user knows that his/her device has not been individually registered in connection with the user, thereby supporting privacy of the test process. Once the device is handed out to the user, the user can privately open/break the seal and read the identification code, which can then be used for later retrieval of the test result, e.g. by entering the code into a respective web interface. Since no one could link the identification code with the person to be tested (in advance), privacy of the test can be ensured.
Sealing of the identification code can be achieved in various ways. In one example, the identification code can be sealed with a scratchable cover layer. The user can remove the cover layer by scratching it and thereby uncover the identification code. The user
can then copy or store the identification code for later retrieval of the test result, i.e. the identification code may be used as a passcode for the test result. In order to ensure privacy of the test result, the user may keep the code secret, or make at least sure that no one can (directly) link the code with the user. In any case, the identification code should at least partly remain connected with the device (and thus the sample). But even in case the unsealed identification code can be read by a third party, privacy of the test result can be maintained by anonymously collecting the sample devices from many users without registering them in connection with each other.
In another example, the identification code could be implemented as a twin-code, where the same information is coded twice and only one part, or both parts of the twin-code are sealed separately. One part of the twin-code may be unsealed and removed by the user, while the other part of the twin-code may stay sealed or unsealed at the device until the analysis procedure. This supports that not only the process of handing out the sample device to the user but also the process of collecting the sample from the use ensures privacy of the test result. In particular, even in case a user personally submits the sample for the test, no one can read the first part of the twin-code, which has already been removed by the user, or the second part of the twin-code, which is still sealed.
In one example, the user may apply a special software application, e.g. running on a mobile device (such as a mobile phone), to scan the identification code. This software application may then be used to retrieve the test result electronically from a test laboratory. Upon approval by the user, the software application may even register the user’s personal information in order to link this personal information with the identification code, thereby allowing registration and tracking of positive test results by medical authorities. In any case, the whole process ensures a high degree of privacy as well as control by and transparency for the user, while still enabling safe and prompt tracking of test results via medical authorities upon approval by the user.
Another aspect of the present invention relates to a method for eluting a sample collected with the swab tip of the device described heretofore. The method comprises: placing the cap on the sample tube;
injecting a liquid in the cavity of the rod via the through-hole of the cap; centrifugating the device to cause the liquid to percolate the swab tip with the collected sample, wherein the liquid extracts a target item from the sample.
As already explained, once the cap is placed on the sample tube, precisely at its open end, the rod and the swab tip having the collected sample on it are situated inside the sample tube. In order to analyze the sample located on the swab tip, the sample may need to be treated with one or more substances. For example, if viral RNA has to be extracted to detect the presence of a virus (e.g. SARS-CoV2), a lysis buffer may be combined with the biological sample to break the potentially virus-infected cells.
Thanks to the features of the sampling-elution element, a liquid (e.g. a solution) can be easily injected in the cavity of the rod via the through-hole and from the cavity it can reach the swab tip. Specifically, the device is centrifuged to push the liquid towards the swab tip with the collected sample. Once the liquid has reached the swab tip, in virtue of its permeability, the liquid can percolate the swab tip and, hence, interact with the sample. The liquid is configured to extract and preserve a given target item from the sample, e.g. the RNA of the cells, which is mix of a patient’s RNA and viral RNA, if present.
Thus, according to the invention, a target item can be efficiently eluted from a sample thanks to the sampling-elution element, which integrates the sampling function and the elution function, the latter being fulfilled in cooperation with the sample tube, which serves as container for the target item. The use of the sampling-elution element requires a smaller quantity of liquid (e.g. buffer) to extract the target item in comparison to conventional apparatuses, which leads to a higher concentration of the target item and, in turn, to a higher sensitivity. Furthermore, the target item is more effectively eluted by applying the buffer “from inside out”, namely by channeling it through the rod and making it elute the target item outwards into the sample tube. The throughput time is also reduced. Finally, the device described heretofore is cheap and easy to produce.
In a particular example, the sample tube may be secured to a rack and centrifugating the device may comprises centrifugating the rack. In other words, the device gets centrifuged in virtue of the fact that it is placed into a rack, which is placed in a centrifuge.
Yet another aspect of the present invention relates to a use of the device described above for collecting a nasal swab and detecting presence of SARS-CoV2-RNA in the nasal swab.
Brief Description of the Drawings
Details of exemplary embodiments are set forth below with reference to the exemplary drawings. Other features will be apparent from the description, the drawings, and from the claims. It should be understood, however, that even though embodiments are separately described, single features of different embodiments may be combined to further embodiments.
Figure 1 shows an example of a swab tube.
Figure 2 shows different views of the components of an exemplary swab tube.
Figure 3 shows an exemplary use of a swab in a nasal cavity.
Figure 4 shows an exemplary swab tube in different phases.
Figure 5 shows a movement of an exemplary swab tube during centrifugation.
Figure 6 shows an exemplary sampling-elution element in a 96-well plate.
Figure 7 shows an exemplary swab tube in a 96-well rack.
Detailed Description
In the following, a detailed description of examples will be given with reference to the drawings. It should be understood that various modifications to the examples may be
made. Unless explicitly indicated otherwise, elements of one example may be combined and used in other examples to form new examples.
Figure 1 shows an example of a swab tube 100. The swab tube 100 comprises a cylindrical sample tube 10 having an open end 13 and a floor 15. The open end 13 provides access to the hollow inside of the sample tube 10 and it is a circular hole formed by the rim of the wall of the sample tube 10. The floor 15 is a circular surface that closes the cylindrical sample tube 10 and is located in the lower half of the sample tube 10.
The bottom part 17 of the sample tube 10, i.e. the part of the tube wall below the floor plus the floor itself, is configured for attaching the sample tube 10 to a rack, specifically a 96-position rack 50 (as shown in Fig. 7). The bottom part 17 may comprise protrusions that are configured to be inserted in respective recesses of a well when screwing the swab tube 100 to the rack 50 or may have a hexagonal shape.
The swab tube 100 further comprises a cap 22, a rod 24 and swab tip 26 connected to each other to form a sampling-elution element 20. Figure 2 shows different views of these components of the exemplary swab tube 100. Specifically, view A is an exploded view of the sampling-elution element 20 and view B is a cut of view A.
The cap 22 is configured to be placed on the open end 13 of the sample tube 10, so that the sampling-elution element 20 closes the sample tube 10. The cap 22 comprises a main body 210 and an engaging part 230. The diameter of the main body 210 is substantially identical to the diameter of the sample tube 10. The main body 210 is a hollow cylinder and comprises part of a through-hole 220, also denoted as “cap portion” of the through-hole 220. The cap portion has a first sector having a first diameter and a second sector having a second diameter being smaller than the first diameter, the two sectors being joined by a tapered portion.
The engaging part 230 is in the shape of an external thread configured to fit within the sample tube 10. In particular, the sample tube 10 comprises an internal thread to which
the engaging part 230 can be screwed, e.g. automatically, such as by a robot. When the cap 22 is fastened to the sample tube 10, the rest of the sampling-elution element 20 (i.e. the rod 24 and the swab tip 26) is positioned inside the sample tube 10.
The part of the through-hole 220 in the engaging part 230 comprises a receiving portion 225. The rod 24 is connected to the cap 22 in that the upper extremity of the rod 24 is inserted in the receiving portion 225 of the through-hole 220. The part of the through- hole 220 in the engaging part 230 further comprises a narrow portion and a tapered portion that connects the narrow portion to the second sector of the cap portion.
Accordingly, one extremity of the rod 24 is held within the engaging part 230. The rod 24 comprises a cavity 240 extending throughout its length and, when connecting the rod 24 to the cap 22, the cavity 240 becomes a continuation of the through-hole 220.
The swab tip 26 is connected to the other extremity of the rod 24. The swab tip 26 comprises a connecting portion 250 and a sampling portion 270, wherein the connecting portion 250 is inserted in the cavity 240. The connecting portion 250 is a cylinder configured to fit within the cavity and it comprises a plurality of ring-shaped protrusions for press-fitting the connecting portion 250 of the swab tip 26 into the rod 24.
The swab tube 100 may optionally comprise a rubber seal 290 configured to be placed on the cap 22 and seal the through-hole 220.
The sampling portion 270 protrudes from the rod 24 and it is the part of the sampling- elution element 20 on which the sample is to be collected. For example, a sample can be collected by smearing the sampling portion 270 of the swab tip 26 in the nasal cavity of a patient, as shown in Figure 3.
After a sample has been collected, the sampling-elution element 20 is connected to the sample tube 10 by screwing the cap 22. This is indicated as phase I in Figure 4, which shows an exemplary swab tube 100 in different phases from storing of the sample within the sample tube 10 to obtaining a target item.
In phase II a liquid 30, like a buffer, is input in the through-hole of the sampling-elution element 20, specifically in the hollow main body 210. The swab tube 100 is centrifuged in order to allow the liquid to flow via the through-hole 220 through the cavity 240 (phase III), reach and permeate the swab tip 26 (phase IV), and finally percolate through the swab tip into the sample tube 10 (phase V). Figure 5 shows a movement of an exemplary swab tube 100 during centrifugation, wherein the liquid percolates due to the centrifugal force that arises during centrifugation. At phase VI, the target item extracted from the sample is diluted in the liquid and contained in the sample tube 10.
The sample-elution element 20 can be inserted into one well of a 96-well microplate 40 shown in Figure 6. The centrifugation of the sample-elution element 20 can be carried out by centrifuging the microplate 40.
As mentioned above with reference to Figure 1 , the swab tube 100 can be inserted in one well of a 96-wells rack 50 shown in Figure 7. The centrifugation of the swab tube 100 can be carried out by centrifuging the rack 50.
Claims
1 . A device comprising: a sample tube comprising an open end; a cap configured to close the open end of the sample tube, the cap comprising a through-hole; a rod comprising a cavity, the rod being connected to the cap such that the cavity is in communication with the through-hole; and a swab tip connected to the rod such that the swab tip is in communication with the cavity; wherein the rod and the swab tip are configured to be positioned within the sample tube when the open end of the sample tube is closed by the cap.
2. The device of claim 1 , wherein the sample tube comprises a bottom part opposite the open end and the bottom part is configured to be secured to a well plate.
3. The device of claim 2, wherein the bottom part comprises a first locking portion configured to engage with a second locking portion in the well plate.
4. The device of claim 2, wherein the bottom part has a cross-section in a plane perpendicular to a length of the sample tube that has a shape of a polygon.
5. The device of any one of the preceding claims, wherein the swab tip is coated with nylon.
6. The device of any one of the preceding claims, wherein the sample tube comprises an internal thread and the cap comprises an external thread.
7. The device of any one of the preceding claims further comprising an identification code placed on the sample tube.
8. The device of claim 7, wherein the identification code is sealed, such that it is hidden until a seal is broken.
9. The device of claim 7 or 8, wherein the identification code is placed on a floor of the sample tube.
10. Use of a device according to any one of claims 1 to 9 for collecting a nasal swab and detecting presence of SARS-CoV2-RNA in the nasal swab.
11. A method for eluting a sample collected with the swab tip of the device according to any one of claims 1 to 9, the method comprising: placing the cap on the sample tube; injecting a liquid in the cavity of the rod via the through-hole of the cap; centrifugating the device to cause the liquid to percolate the swab tip with the collected sample, wherein the liquid extracts a target item from the sample.
12. The method of claim 11, wherein the method further comprises securing the sample tube to a well plate and centrifugating the device comprises centrifugating the well plate.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP21720750.5A EP4326161A1 (en) | 2021-04-22 | 2021-04-22 | Swab tube |
PCT/EP2021/060567 WO2022223121A1 (en) | 2021-04-22 | 2021-04-22 | Swab tube |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/EP2021/060567 WO2022223121A1 (en) | 2021-04-22 | 2021-04-22 | Swab tube |
Publications (1)
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WO2022223121A1 true WO2022223121A1 (en) | 2022-10-27 |
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PCT/EP2021/060567 WO2022223121A1 (en) | 2021-04-22 | 2021-04-22 | Swab tube |
Country Status (2)
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EP (1) | EP4326161A1 (en) |
WO (1) | WO2022223121A1 (en) |
Citations (4)
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US20050131314A1 (en) * | 2003-11-17 | 2005-06-16 | Hird Robert F. | Methods and apparatus for the rapid detection of microorganisms collected from infected sites |
US20100248213A1 (en) * | 2007-07-23 | 2010-09-30 | Feiglin Marc N | Collection/extraction container for biological material in forensic samples |
US9554780B2 (en) * | 2011-03-01 | 2017-01-31 | Infogene Lda. | Portable device for the storage, transport and recuperation of biological material |
WO2021048778A1 (en) * | 2019-09-11 | 2021-03-18 | Copan Italia S.P.A. | Releasing stopper, container provided with stopper and kits and releasing method associated thereto |
-
2021
- 2021-04-22 WO PCT/EP2021/060567 patent/WO2022223121A1/en active Application Filing
- 2021-04-22 EP EP21720750.5A patent/EP4326161A1/en active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050131314A1 (en) * | 2003-11-17 | 2005-06-16 | Hird Robert F. | Methods and apparatus for the rapid detection of microorganisms collected from infected sites |
US20100248213A1 (en) * | 2007-07-23 | 2010-09-30 | Feiglin Marc N | Collection/extraction container for biological material in forensic samples |
US9554780B2 (en) * | 2011-03-01 | 2017-01-31 | Infogene Lda. | Portable device for the storage, transport and recuperation of biological material |
WO2021048778A1 (en) * | 2019-09-11 | 2021-03-18 | Copan Italia S.P.A. | Releasing stopper, container provided with stopper and kits and releasing method associated thereto |
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EP4326161A1 (en) | 2024-02-28 |
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