Sample collection devices and systems

Abstract

The sample collection device includes a housing including an exhalation portion and a coupling portion. The coupling portion may be coupled to / with a sample collection tube. An airflow path extends through the housing. The device further includes a porous sample collection medium disposed partially within the housing and arranged to block the airflow path. The porous sample collection medium includes a nonwoven material and may include polylactic acid, polypropylene, or combinations thereof. The housing may be a single piece, element, or component, or may be multiple pieces, elements, components, or portions. In a two-piece housing embodiment, a first element includes an exhalation piece (e.g., a mouthpiece or nosepiece) and a second element includes a coupling end constructed to couple with the sample collection tube. A method of obtaining a sample using the sample collection device includes blowing into the exhalation piece or exhalation portion to collect a sample on the porous sample collection medium, coupling the second element or portion to the sample collection tube, and transferring the collected sample on the porous sample collection medium to the sample collection tube.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to sample collection devices and systems. FIELD OF THE DISCLOSURE The present disclosure relates to bio-aerosol collection devices and systems. [Background technology]

[0002] Diagnostic tests used to test for the presence of viruses or other pathogens in the respiratory tract, throat, or nasopharynx typically involve the insertion of a swab into the back of the nose, the middle turbinate area of ​​the nose, the anterior nares, or into the throat to obtain a sample. The swab is then inserted into a container and analyzed or sent to a laboratory for processing. Other diagnostic tests involve collecting a saliva sample and then placing it into a container. Currently available home virus tests (e.g., COVID-19 tests) involve nasal swabs and test kits (e.g., Ellume™ test, Abbot™ BinaxNOW™ test, and Lucira™ All-in-One Test Kit). Tests that utilize nasal swab samples or saliva compete with contaminants that can interfere with various diagnostic tests. As a result, these sample types require purification steps when using RT-PCR molecular tests. Summary of the Invention

[0003] There is a need for an inexpensive, easy to use, reliable sample collection system that can be used by the public to obtain samples for testing for the presence of a target virus, pathogen, or other analyte in the collected sample. The sample collection system may include a sample collection device for collecting a sample from the exhaled airstream onto a sample collection medium and a transfer mechanism for transferring the sample to a sample collection tube, which may be used to analyze the sample or transport the sample to a facility for testing.

[0004] It is desirable to provide sample collection devices and systems that are easy to use, which may advantageously be self-contained and optionally sterile. Self-contained (and optionally sterile) devices and systems may improve the accuracy and reliability of pathogen testing due to reduced contamination and background noise, unlike swabs and other test collection devices that may be contaminated during use and / or testing.

[0005] It is further desirable to provide a system in which, following sample collection, a means is provided for easily transferring the collected sample to a sample collection tube, which may be sealed and, optionally, transported safely and without contamination for testing.

[0006] According to one embodiment, a sample collection device includes a housing including an exhalation portion and a coupling portion. The coupling portion can be coupled to a sample collection tube. An airflow path extends through the housing. The device further includes a porous sample collection medium partially disposed within the housing and arranged to block the airflow path. The housing may be a single piece, element, or component, or may be multiple pieces, elements, components, or portions.

[0007] In an exemplary embodiment, the housing includes a first element and a second element removably coupled to each other and an airflow path extending through the first element and the second element. The first element includes an exhalation piece. The second element includes a coupling end constructed to couple with a sample collection tube. The device further includes a porous sample collection medium disposed partially between the first element and the second element to block the airflow path. Each of the first element and the second element may have a tubular body. When the first element and the second element are coupled, the tubular body of the first element may be coaxial with the tubular body of the second element. The second element may further include a coupling mechanism constructed to couple with a sample collection tube or a cap.

[0008] The porous sample collection body comprises a nonwoven material. The nonwoven material may comprise polylactic acid, polypropylene, or a combination thereof. The nonwoven material may be electrostatically charged.

[0009] A system for collecting a sample from a breath includes a sample collection device and a plunger for expelling a porous sample collection medium from a housing. The system may further include a sample collection tube capable of being coupled to a second component. The system may be constructed to expel the porous sample collection medium into the sample collection tube coupled to the sample collection device when pressed with the plunger.

[0010] A method of obtaining a sample using the sample collection device includes blowing into the breath piece to collect a sample on a porous sample collection medium, coupling a second element with a sample collection tube, and transferring the collected sample on the porous sample collection medium to the sample collection tube. The transferring may be performed by pushing with a plunger. The transferring may be performed by applying a liquid onto the porous sample collection medium.

[0011] A kit for collecting a sample from breath includes a sample collection device, the second element having a mating end constructed to mate with a sample collection tube, the mating end having a first size and a first mating configuration, and an adapter constructed to mate with the mating end of the second element, the adapter having a second mating end having a second size and a second mating configuration different from the first size and the first mating configuration. [Brief description of the drawings]

[0012] [Figure 1A] FIG. 2 is a side view of a sample collection medium, according to one embodiment. [Figure 1B] FIG. 1B is a perspective view of the sample collection device of FIG. 1A. [Figure 1C] FIG. 1B is an exploded view of the sample collection device of FIG. 1A. [Figure 2A] FIG. 1B is a side view of a system including the sample collection device of FIG. 1A. [Figure 2B] FIG. 2B is a perspective view of the system of FIG. 2A. [Figure 2C] FIG. 2B is an exploded view of the system of FIG. 2A. [Figure 3A] FIG. 1B is a top view of a first element of the sample collection device of FIG. 1A. [Figure 3B] FIG. 3B is a side view of the first element of FIG. 3A. [Figure 3C] FIG. 3B is a cross-sectional side view of the first element of FIG. 3A. [Figure 3D] FIG. 3B is a cross-sectional top view of the first element of FIG. 3A. [Figure 4A] FIG. 1B is a top view of a second element of the sample collection device of FIG. 1A. [Figure 4B] FIG. 4B is a side view of the second element of FIG. 4A. [Figure 4C] FIG. 4B is a cross-sectional side view of the second element of FIG. 4A. [Figure 4D] FIG. 4B is a cross-sectional view from below of the second element of FIG. 4A. [Figure 5A] FIG. 1B is a side view of an alternative second element of the sample collection device of FIG. 1A. [Figure 5B] FIG. 5B is a bottom perspective view of an alternative second element of the sample collection device of FIG. 5A. [Figure 6A] FIG. 1B is a side view of another alternative second element of the sample collection device of FIG. 1A. [Figure 6B] FIG. 6B is a bottom perspective view of an alternative second element of FIG. 6A. [Figure 6C] FIG. 6B is a top perspective view of an alternative second element of FIG. 6A. [Figure 7] FIG. 1B is a partial cross-sectional view of the sample collection device of FIG. 1A. [Figure 8A] FIG. 2B is a perspective view of the system of FIG. 2A including a plunger. [Figure 8B] FIG. 8B is an exploded view of the system of FIG. 8A. [Figure 9A] FIG. 1B is a perspective view of an alternative first element of the device of FIG. 1A. [Figure 9B] FIG. 9B is a perspective view of a system having an alternative first element of FIG. 9A. [Figure 10] FIG. 1B is a schematic side view of a kit including the sample collection device of FIG. 1A and a number of adapters. [Figure 11A] FIG. 2 is a side view of a sample collection device, according to one embodiment. [Figure 11B] FIG. 11B is a perspective view of the sample collection device of FIG. [Figure 12A] FIG. 11B is a side view of the sample collection device of FIG. [Figure 12B] FIG. 12B is a cross-sectional view of the sample collection device of FIG. 12A. [Figure 13A] FIG. 11B is a side view of a first element and a second element of the sample collection device of FIG. 11A. [Figure 13B] FIG. 11B is a perspective view of a first element and a second element of the sample collection device of FIG. 11A. [Figure 14A] FIG. 11B is a top view of a first element of the sample collection device of FIG. [Figure 14B] FIG. 14B is a side view of the first element of FIG. 14A. [Figure 15A] FIG. 11B is a side view of a first element and a second element of the sample collection device of FIG. 11A. [Figure 15B] FIG. 14B is a cross-sectional view of the sample collection device of FIG. 14A. [Figure 16] FIG. 1 is a perspective view of a sample collection device, according to one embodiment. [Figure 17] FIG. 11B is a perspective view of a system including the sample collection device of FIG. [Figure 18] FIG. 14B is a partial enlarged view of the bottom of the sample collection device of FIG. 14A.

[0013] definition All scientific and technical terms used herein have the meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to aid in the understanding of certain terms used frequently herein and are not intended to limit the scope of the present disclosure.

[0014] Unless otherwise indicated, the terms "polymer" and "polymeric material" include, but are not limited to, organic homopolymers, copolymers (such as block, graft, random and alternating copolymers for capturing viruses, pathogens or other analytes borne in breath), terpolymers, and the like, as well as blends and modifications thereof. Furthermore, unless otherwise specifically limited, the term "polymer" is intended to encompass all possible geometric configurations of the material. These configurations include, but are not limited to, isotactic, syndiotactic, and atactic symmetries.

[0015] The terms "downstream" and "upstream" refer to relative locations based on the direction of exhaled airflow through the device, e.g., the most upstream element of the device is the exhalation piece element and the most downstream element of the device is the distal end (e.g., the tubing connection end).

[0016] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of the text that follows the heading, unless specifically stated.

[0017] The term "ie" is used herein as an abbreviation of the Latin phrase id est, meaning "that is," and "eg" is used herein as an abbreviation of the Latin phrase exempli gratia, meaning "for example."

[0018] All scientific and technical terms used herein have the meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to aid in the understanding of certain terms used frequently herein and are not intended to limit the scope of the present disclosure.

[0019] The term "about" is used herein in conjunction with numerical values ​​to include normal variations in measurements expected by one of ordinary skill in the art, and can be understood to have the same meaning as "approximately" and to cover typical margins of error, such as ±5% of the stated value. Additionally, unless otherwise indicated, all numbers expressing quantities and all terms expressing direction / orientation (e.g., vertical, horizontal, parallel, perpendicular, etc.) used in this specification and claims are to be understood as being modified in all instances by the term "approximately."

[0020] Terms such as "a," "an," and "the" are not intended to refer to a singular entity only, but include generic types that may be used to illustrate specific examples.

[0021] The terms "a," "an," and "the" are used interchangeably with the term "at least one." The phrases "at least one of" and "including at least one of" following a list refer to any one of the items in the list, as well as any combination of two or more items in the list.

[0022] As used herein, the term "or" is generally used in its ordinary sense including "and / or" unless the content specifically dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0023] The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.; or up to 10 includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). When a range of values ​​is stated "up to" or "at least" a particular value, the value is included in that range.

[0024] As used herein, "have," "having," "include," "including," "comprise," "comprising," and the like are used in an open-ended sense, generally meaning "including, but not limited to." "Consisting essentially of," "consisting of," and the like will be understood to be encompassed by "comprising," and the like. As used herein, "consisting essentially of," when referring to a composition, product, method, and the like, means that the components of the composition, product, method, and the like are limited to the recited components and any other components that do not materially affect the basic and novel property(s) of the composition, product, method, and the like.

[0025] The term "substantially" as used herein can be understood to have the same meaning as "significantly" and to modify the following term by at least about 90%, at least about 95%, or at least about 98%. The term "not substantially" as used herein can be understood to have the same meaning as "not significantly" and to have the opposite meaning of "substantially", i.e., to modify the following term by no more than 10%, no more than 5%, or no more than 2%.

[0026] The words "preferred" and "preferably" refer to embodiments that may provide certain benefits, in certain circumstances, although other embodiments may also be preferred, under the same or other circumstances. Moreover, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0027] Any directions referred to herein, such as "front," "rear," "top," "bottom," "left," "right," "upper," "lower," and other directions and orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system or the use of the device or system. A device or system as described herein can be used in several directions and orientations.

[0028] Any directions referred to herein, such as "top," "bottom," "left," "right," "upper," "lower," and other directions and orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system or the use of the device or system. A device or system as described herein can be used in several directions and orientations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] FIELD OF THE DISCLOSURE The present disclosure relates to sample collection devices and systems.

[0030] The sample collection device includes a porous sample collection medium along an airflow path defined by the device housing. The porous sample collection medium is the constructed airflow. After loading, the sample collection medium may be transferred to a sample collection tube. The collection medium may be transferred to the sample collection tube. The sample may be further analyzed for the presence of the pathogen of interest or the sample collection tube may be capped and sent elsewhere for analysis. According to an alternative embodiment, the sample may be transferred to the sample collection tube by passing a liquid through the porous sample collection medium to elute the sample containing the pathogen, virus or other analyte bound to the porous sample collection medium to form an eluent and allowing the eluent to flow into the sample collection tube. The eluent may then be analyzed using known methods.

[0031] According to one embodiment, the sample collection device includes a housing. The housing includes a first element and a second element that define an airflow path. The porous sample collection medium is disposed within the housing and positioned to block the airflow path. The porous sample collection medium may be retained between the first element and the second element. According to one embodiment, the porous sample collection medium is retained between the first element and the second element such that it remains in place during sample loading but can be easily pushed out when required. A user may breathe into the sample collection device to load the porous sample collection medium with a sample of the exhaled airflow to form a loaded porous sample collection medium. The user may breathe through an opening in an exhalation piece on the first element. The exhalation piece may be used to breathe through the mouth (e.g., may be a mouthpiece) or through the nose (e.g., may be a nosepiece). The housing is constructed such that the exhaled airflow passes through the porous sample collection medium by blowing through the opening in the exhalation piece. The porous sample collection medium is constructed to capture viruses, other pathogens, or other analytes from the exhaled airstream. The user may then transfer the loaded sample collection medium into a sample collection tube. Alternatively, as described above, the user may elute the sample from the loaded sample collection medium directly into the sample collection tube.

[0032] The first and second elements of the housing are removably coupled to each other. In alternative embodiments, the first and second elements are permanently coupled to each other such that they cannot be separated without destroying or deforming the elements. The first piece has a proximal end and an opposite distal end. The proximal end may form an exhalation piece, such as a mouthpiece or nosepiece. The exhalation piece may be configured to accommodate exhalation through either the mouth or nose. In some embodiments, the distal end of the first element is received within the second element. Thus, the second element is the outer element and the first element is the inner element. Alternatively, the device may be configured such that the second element is received within the first element, in which case the first element is the outer element and the second element is the inner element, and the features connecting the first and second elements are reversed. The second element (or the outer element) may include a shelf within the second element. The outer edge of the sample collection medium may be retained between a shelf of the second element and a distal end of the first element.

[0033] According to one embodiment, the housing has a central longitudinal axis. An airflow channel extends through both the first element and the second element. The airflow channel may extend along the central longitudinal axis. One or both of the first element and the second element may include a tubular body. The tubular bodies may be coaxial when the first element and the second element are mated.

[0034] The first and second elements may be coupled by any suitable mechanism. For example, the first and second elements may be coupled by a bayonet coupling, an interference fit, a snap fit, or a threaded coupling. In one embodiment, the first and second elements are coupled by a bayonet coupling. When configured for a bayonet coupling, the first element may include one or more protrusions and the second element may include one or more corresponding grooves constructed to receive and guide the one or more protrusions. Alternatively, one or more protrusions may be on the second element and one or more grooves may be on the first element.

[0035] According to one embodiment, the second element has a proximal end and an opposing distal end. The proximal end of the second element is constructed to mate with the first element (e.g., constructed to receive the distal end of the first element). The distal end of the second element is a tube coupling end constructed to mate with a sample collection tube. The distal end may include any suitable mechanism for coupling with a sample collection tube. For example, the tube coupling end may be constructed for a bayonet coupling, an interference fit, a snap fit, or a screw coupling. Many commercially available sample collection tubes or test tubes have threaded tops for attaching a cap. The tube coupling end of the second element may be constructed to mate with a thread on the sample collection tube. The tube coupling end of the second element may include an internal thread configured to mate with an external thread on the sample collection tube. The tube coupling end of the second element may include two or more different threads with different configurations (e.g., sizes, thread spacing, or thread angles) for attachment to different types or sizes of sample collection tubes. The device may also include adapters for changing the size or type of connection to facilitate different types or sizes of sample collection tubes.

[0036] In some embodiments, the tube coupling end of the second element is configured to provide an interference fit with the sample collection tube. To facilitate the interference fit, the tube coupling end may include a protrusion sized to be received inside the sample collection tube. The coupling end may include a seal, such as an O-ring, to seal the tube coupling end to the sample collection tube.

[0037] To further facilitate holding the sample collection tube in place with an interference fit, the device may include a finger support. A user may hold the sample collection tube in place by holding the end of the tube with one finger and the finger support with another. The finger support may include one or more extensions or flanges extending from the first element or the second element.

[0038] The loaded sample collection medium may be transferred to the sample collection tube by pushing it into the tube with a plunger while the tube is coupled to the sample collection device. In some embodiments, the plunger is a rod configured to fit through the airflow channel. The plunger may include a first end configured as a finger grip and an opposing second end configured to contact and push and remove the sample collection medium. In some embodiments, the plunger is constructed to remain inside the device after transferring the sample collection medium. The plunger may be discarded with the device.

[0039] The porous sample collection medium may be a nonwoven material capable of capturing pathogens, viruses, or other analytes from the exhaled airstream. According to one embodiment, the porous sample collection medium is a nonwoven material carrying an electrostatic charge. The electrostatic charge may enable capturing pathogens, viruses, or other analytes from the exhaled airstream. In some cases, the porous sample collection medium may be a hydrophobic nonwoven material. In other cases, the porous sample collection medium may be a hydrophilic nonwoven material. The porous sample collection medium may be a hydrophobic nonwoven material carrying an electrostatic charge configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The porous sample collection medium may be a hydrophilic nonwoven material configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The term "hydrophobic" refers to a material having a water contact angle of 90 degrees or more, or between about 90 degrees and about 170 degrees, or between about 100 degrees and about 150 degrees. The term "hydrophilic" refers to a material having a water contact angle of less than 90 degrees. Water contact angles are measured using the ASTM D5727-1997 Standard Test Method for Surface Wettability and Absorbency of Sheet Materials using an automated contact angle tester.

[0040] The porous sample collection medium may be formed of any suitable material capable of capturing viruses, pathogens or other analytes from the exhaled airstream and releasing the captured viruses, pathogens or other analytes upon contact with an eluent such as saline. The porous sample collection medium may be formed of a polymeric material. The porous sample collection medium may be formed of a polyolefin. Examples of suitable polyolefins include polypropylene, polylactic acid, and the like, and combinations thereof. In one embodiment, the porous sample collection medium may be formed of polypropylene. In one embodiment, the porous sample collection medium is formed of polylactic acid. One exemplary porous sample collection medium is commercially available under the trade name FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus Air Filter Merv 13 from 3M Company (St. Paul MN, USA).

[0041] The porous sample collection medium may have a thickness (orthogonal to the major surface) of 200 μm or more, or 250 μm or more. The porous sample collection medium may have a thickness of 750 μm or less, or 1000 μm or less. The porous sample collection medium may have a thickness in the range of 200 μm to 1000 μm, or 250 μm to 750 μm. The porous sample collection medium may have a thickness of 1 cm 2 More than 2cm 2 The porous sample collection medium may have a major planar surface area (per side) of 3 cm or more. 2 Less than or equal to 4cm 2 The porous sample collection medium may have a major planar surface area of ​​1 cm 2 ~4cm 2 , or 2 cm 2 ~3cm 2 The surface area of ​​the major planar surface may be in the range of 0.1 to 1.0 mm.

[0042] The housing may be formed of any suitable material. The housing may be formed of a rigid material such as plastic, metal, glass, or the like, or a combination thereof.

[0043] The sample collection system may be provided as a kit, which may include a sample collection device as described above and one or more adapters configured to couple sample collection tubes of various sizes or styles to the device.

[0044] In some embodiments, the sample is eluted from the sample collection medium by dispensing a liquid onto the loaded sample collection medium. The liquid dispensed onto the sample collection medium may be an aqueous liquid. The liquid may be a buffer solution. The liquid may be an aqueous buffer solution. The liquid may be saline. The liquid may include a surfactant. The liquid may have a contact angle greater than 90 degrees when measured on the porous sample collection medium. The liquid may be saline containing a surfactant. The liquid (e.g., buffer or saline) may include 0.1% or more, or 0.5% or more, and up to 1% or up to 2% by weight of a surfactant. When provided as a metered amount, the liquid may have a volume of 50 μL to 500 μL.

[0045] A liquid may be applied onto the loaded porous sample collection medium. The liquid may pass through the surface and thickness of the loaded porous sample collection medium and flow out of the porous sample collection medium, carrying with it any viruses, pathogens or other analytes that were present on the loaded porous sample collection medium. This loaded liquid may then be collected and tested as described herein.

[0046] 1A-1C, a sample collection device 1 is shown. The sample collection device 1 has a housing 10 made of two elements, a first element 100 and a second element 200. The first element 100 and the second element 200 are joined together to form a breathing tube through which an airflow path 12 extends. A gap 13 is formed between the first element 100 and the second element 200, as will be further described below (see FIG. 7). A piece of sample collection medium 300 is disposed within the housing 10 such that the sample collection medium 300 occludes the airflow path 12. An outer edge 303 of the porous sample collection medium 300 may be retained in the gap 13 between the first element 100 and the second element 200.

[0047] The first element 100 is configured to mate with the second element 200. In the illustrated embodiment, the distal end 102 of the first element 100 is received within the second element 200. The outer surface 112 of the tubular body 110 may include a coupling mechanism. A corresponding coupling mechanism may be formed on the inner surface of the second element 200. In the illustrated embodiment, the coupling mechanism is a bayonet connection, but other coupling mechanisms may also be used. The outer surface 112 of the tubular body 110 of the first element 100 includes one or more (e.g., two) protrusions 140. The one or more protrusions 140 may be received within one or more corresponding grooves 240 on the inner surface 213 of the second element 200.

[0048] The housing 10 has a central longitudinal axis A10. In the illustrated embodiment, the airflow path 12 extends along the central longitudinal axis A10 of the housing 10. The airflow path 12 extends through both the first element 100 and the second element 200. The first element 100 and the second element 200 may be coaxial when coupled together.

[0049] According to one embodiment, as shown in Figures 2A-2C, the sample collection device 1 may be coupled to a sample collection tube 20. The second element 200 has a distal end 202 configured as a tube coupling end for coupling to the sample collection tube 20. After loading the sample onto the porous sample collection medium 300 by blowing into the sample collection device 1, the user may transfer the sample to the sample collection tube 20. The sample may be transferred by transferring the loaded sample collection medium 300 to the sample collection tube 20, for example, by removing the sample collection medium 300 using the plunger 30 (see Figures 8A and 8B). Alternatively, the sample may be transferred by eluting the sample with a suitable eluent, as described above. The eluent may be applied through the airflow path 12.

[0050] The second element 200 may include a tube coupling mechanism 250 adjacent the distal end 202 (see FIGS. 4A-6C). In the illustrated embodiment, the tube coupling mechanism 250 comprises threads 251. A sample collection tube 20 having a threaded mouth 22 may be coupled with the threads 251. The sample collection tube 20 may include external threads 21.

[0051] 3A-3D, the first element 100 of the housing 10 is shown in more detail. The first element 100 defines a proximal end 101 and an opposing distal end 102. The airflow path 12 extends through the first element 100 from the proximal end 101 to the distal end 102. The airflow path 12 may extend along a central longitudinal axis A100 of the first element 100. The first element 100 may have a tubular body 110 defining an inner surface 111, an outer surface 112, and an interior 114. The interior 114 forms a portion of the airflow path 12. An exhalation piece 120 may be formed at the proximal end 101. The exhalation piece 120 may be a ring extending outwardly from the tubular body 110 as shown. The protrusions 140 extend outwardly from the outer surface 112 of the tubular body 110 .

[0052] 4A-4D, a second element 200 of the housing 10 is shown. The second element 200 defines a proximal end 201 and an opposing distal end 202. The airflow path 12 extends through the second element 200 from the proximal end 201 to the distal end 202. The airflow path 12 may extend along a central longitudinal axis A200 of the second element 200. The second element 200 may have a tubular body 210 defining an interior 214. The interior 214 forms a portion of the airflow path 12. The interior 214 of the proximal end 201 may be configured to receive and couple with the first element 100. The interior 214 of the proximal end 201 may include a coupling mechanism configured to cooperate with a coupling mechanism on the first element 100. In the illustrated embodiment, the second element 200 has one or more (e.g., two) grooves 240 constructed to receive one or more protrusions 140 of the first element. The grooves 240 may include a longitudinal element 241 and a connected horizontal element 242. The longitudinal element 241 may extend parallel to the central longitudinal axis A200.

[0053] The distal end 202 of the second element 200 may be configured as a tube coupling end. The second element 200 may include a tube coupling mechanism 250 adjacent the distal end 202. In the illustrated embodiment, the tube coupling mechanism 250 includes threads 251; however, other coupling mechanisms may also be used. The threads 251 are formed on an inner surface 213 of the second element 200. A sample collection tube 20 having a threaded mouth 22 may be coupled with the threads 251 (see FIG. 2C).

[0054] The diameter of the second element 200 may vary along the length of the tubular body 210. For example, as shown, the proximal portion 211, which includes the coupling mechanism for the first portion 100, may have a different diameter D211 than the diameter D212 of the distal portion 212, which includes the coupling mechanism for the sample collection tube 20. Both the inner and outer diameters may be selected independently.

[0055] In some embodiments, the second element has an alternative coupling mechanism, such as an interference fit mechanism. An example of a second element 200' configured for an interference fit with the sample collection tube 20 is shown in Figures 5A and 5B. The second element 200' may otherwise be constructed similarly to the second element 200 shown in Figures 4A-4D, for example. The coupling mechanism 250' at the distal end 202' of the second element 200' includes an extension 254 configured to be received inside the sample collection tube 20. The extension 254 may also have a seal 256 (such as an O-ring) to improve the fit with various sample collection tubes 20. The seal 256 may create a seal between the extension 254 and the inner surface of the sample collection tube 20. The second element 200' may include a reduced diameter portion 218 that reduces in diameter from a diameter D211 of the proximal portion 211 to a diameter D254 of the extension 254. The reduced diameter portion 218 may be conical as shown. The conical surface may also serve as a mating surface with the sample collection tube 20.

[0056] The airflow path 12 extends through the second element 200' and the extension 254. The distal portion 212' of the second element 200' may optionally include air bypass holes 260. This may allow air to be blown through the device more easily if the extension 254, and therefore the airflow path 12, is narrow and restricts airflow.

[0057] Another alternative tube coupling mechanism is shown in Figures 6A-6C. To facilitate use of sample collection tubes 20 of different sizes (e.g., having different diameters), the distal portion 212'' of the second element 200'' may include multiple sets of threads 252, 253. The second element 200'' (including the proximal portion 211) may otherwise be constructed similarly to the second element 200 shown in Figures 4A-4D. The first set of threads 252 may have a first diameter D252 and the second set of threads 253 may have a second diameter D253 that is larger than the first diameter D252. The second set of threads 253 is distal to the first set of threads 252. A smaller diameter sample collection tube may be pushed further into the second element 200'' to reach the smaller first set of threads 252, and a larger diameter sample collection tube may be screwed onto the larger second set of threads 253.

[0058] Referring now to FIG. 7, a schematic partial cross-sectional view of the device 1 is shown. According to one embodiment, the porous sample collection medium 300 is retained between the distal end 102 of the first element 100 and the shelf 230 of the second element. When the first element 100 and the second element 200 are coupled, for example by a bayonet connection, a gap 13 is formed between the distal end 102 of the first element 100 and the shelf 230 of the second element. The gap 13 has a length L13. The porous sample collection medium 300 has a thickness T300, which is equal to or less than the length L13 of the gap 13. In some embodiments, the thickness T300 is less than the length L13. This allows the porous sample collection medium 300 to be easily removed when required.

[0059] The sample collection medium 300 may be disposed inside the housing 10 such that the first major surface 301 and the second major surface 302 of the sample collection medium 300 are perpendicular or substantially perpendicular to the airflow path 12. The sample collection medium 300 is preferably sized and shaped such that the outer edge 303 of the sample collection medium 300 is retained in the gap 13 along the entire perimeter of the sample collection medium 300. Although the porous sample collection medium 300 is shown here as defining a substantially circular planar element, it is understood that the porous sample collection medium may define any shape when placed within the housing along the airflow path. The shape and size of the porous sample collection medium 300 may be selected based on the shape and size of the interior 114 of the first element 100 and the interior 215 of the second element 200.

[0060] The sample collection device 1 may be provided as a system 2 that also includes a plunger 30 configured to remove the porous sample collection medium 300 from the device 1, as shown in Figures 8A and 8B. According to one embodiment, the housing 10 may be coupled to the sample collection tube 20, and the plunger 30 may be used to push through the housing 10 and push the porous sample collection medium 300 down into the sample collection tube 20. The plunger 30 may be a rod sized to fit through the exhalation piece 120 and the airflow path 12. In some embodiments, the first element 100 may include a plunger guide 123, as shown in Figures 9A and 9B. The plunger 30 may include a first end 31 configured as a finger grip and an opposing second end 32 configured to contact and remove the sample collection medium 300.

[0061] The plunger guide 123 can aid in guiding the plunger 30 through the center of the housing 10. This may be desirable, particularly in embodiments where the sample collection tube 20 has a larger diameter than the plunger guide 123. The plunger guide 123 comprises a tubular element attached to the first element 100 inner surface 111. The plunger guide 123 is centered along the central longitudinal axis A100 of the first element.

[0062] The housing 10' may include one or more finger supports 150, as shown in Figures 9A and 9B. A user may hold the sample collection tube 20 in place relative to the housing 10' by holding the distal end of the tube 20 with one finger and holding the finger support 150 with one or more other fingers. The finger support 150 includes an extension that extends from the outer surface 112 of the first element 100'. Alternatively, the finger support 150 may extend from the second element 200.

[0063] In some embodiments, the sample collection device 1 is provided as a kit 3 including the sample collection device 1 and one or more adapters 280, 281, 282, as shown in FIG. 10. The adapters 280, 281, 282 are configured to couple sample collection tubes of various sizes or styles to the device 1. Each adapter 280, 281, 282 has a first end 284 configured to couple with a tube coupling mechanism 250 of the second element 200. The first end 284 may have threads 288 for coupling with corresponding threads 251 on the second element 200. Alternatively, the first end 284 may be a simple (smooth) tube for an interference fit with the second element 200, e.g., the second element 200′ shown in FIGS. 5A and 5B. Each adapter 280, 281, 282 has a second end 285, 286, 287 configured to couple with a sample collection tube 20. The kit 3 may include a number of different sized adapters 280, 281, 282 having second ends 285, 286, 287 of varying sizes. For example, one adapter 280 may have a second end 285 with a narrow diameter thread. A second adapter 281 may have a second end 286 with a medium diameter thread. A third adapter 282 may have a second end 287 with a wide diameter thread. The threads of the second ends 285, 286, 287 may be female threads similar to the threads 251 on the second element 200. Alternatively, one or more of the adapters 280, 281, 282 may be configured for an interference fit with the sample collection tube 20.

[0064] An alternative embodiment of a sample collection device 1' is shown in Figures 11A-18. The sample collection device 1' has a housing 50 made up of two elements, a first element 500 and a second element 600. The first element 500 and the second element 600 are joined together to form a breathing tube through which an airflow path 52 extends. As with the sample collection device 1, a piece of sample collection medium 300 is disposed within the housing 50 such that the sample collection medium 300 occludes the airflow path 52.

[0065] The first element 500 is configured to mate with the second element 600. The first element 500 defines a proximal end 501 and an opposing distal end 502. The first element 500 may have a tubular body 510 defining an interior 514 and an exterior surface 512. The interior 514 forms a portion of the airflow path 52. The proximal end 501 of the tubular body 510 may be formed with a flange 520. The flange 520 may extend outwardly from the proximal end 501. The flange 520 may function as a mouthpiece or a nosepiece. The distal end 502 of the first element 500 is received in the second element 600.

[0066] The second element 600 defines a proximal end 601 and an opposing distal end 602. The airflow path 52 extends through the second element 600 from the proximal end 601 to the distal end 602. The second element 600 may have a tubular body 610 defining an interior 614. The interior 614 of the proximal end 601 may be configured to receive and couple to the first element 500. The outer surface 512 of the tubular body 510 may include a coupling mechanism. A corresponding coupling mechanism may be formed on the inner surface 613 of the second element 600. In the illustrated embodiment, the coupling mechanism is a snap connection, although other coupling mechanisms may also be used. The outer surface 512 of the tubular body 510 of the first element 500 includes a ring 540. The ring 540 may be received in a corresponding groove 640 on the inner surface 613 of the second element 600. The exterior surface 512 of the tubular body 510 may include a protrusion 541. The protrusion 541 may aid in aligning the first element 500 and the second element 600. The protrusion 541 may aid in maintaining the orientation of the first element 500 and the second element 600 along a vertical axis or when disposed at a fixed or variable angle relative to one another.

[0067] The housing 50 has a central longitudinal axis A50. In the illustrated embodiment, the airflow path 52 extends along the central longitudinal axis A50 of the housing 50. The airflow path 52 extends through both the first element 500 and the second element 600. The first element 500 and the second element 600 may be coaxial when coupled together.

[0068] The second element 600 may include a reduced diameter portion 618 similar to the reduced diameter portion 218 of the second element 200. The second element 600 may include an air bypass hole 660. The air bypass hole 660 may be disposed in the reduced diameter portion 618.

[0069] According to one embodiment, the sample collection device 1' may be coupled to a sample collection tube 20, as shown in FIG. 17. The second element 600 has a distal end 602 configured as a tube coupling end for coupling to the sample collection tube 20. After loading the sample onto the porous sample collection medium 300 by blowing into the sample collection device 1', the user may transfer the sample to the sample collection tube 20. The sample may be transferred by transferring the loaded sample collection medium 300 to the sample collection tube 20, for example, by removing the sample collection medium 300 using the plunger 30 (see FIGS. 8A and 8B). Alternatively, the sample may be transferred by eluting the sample with a suitable eluent, as described above. The eluent may be applied through the airflow path 52.

[0070] The second element 600 includes a tube coupling extension 680 adjacent the distal end 602. The tube coupling extension 680 may include features that aid in securing the tube coupling extension 680 inside the sample collection tube 20. In the illustrated embodiment, the tube coupling extension 680 includes a frusto-conical portion 681 and one or more rings or ribs 682 extending outwardly from the frusto-conical portion 681. The frusto-conical portion 681 may taper toward the distal end 602, as shown. According to one embodiment, the tube coupling extension 680 includes a plurality of ribs 682. The ribs 682 at least partially engage the inner surface of the sample collection tube 20. The ribs 682 may aid in holding the sample collection device 1′ connected to the sample collection tube 20 during transfer of sample to the sample collection tube 20.

[0071] According to one embodiment, the ribs 682 may be deformable, i.e., when the tube coupling extension 680 is inserted into the sample collection tube 20, the ribs 682 deform beyond a yield point to provide an interference fit with the sample collection tube 20. The frustoconical portion 681 may also be formed with a thin wall, which provides additional flexibility to aid in the fit.

[0072] The plurality of ribs 682 may have different sizes or diameters. The size of the ribs 682 may gradually increase, beginning with a smallest diameter adjacent the distal end 602 and ending with a largest diameter adjacent the reduced diameter portion 618. That is, the plurality of ribs 682 may include at least a first rib having a first diameter adjacent the distal end 602 and a second rib further away from the distal end 602 having a second diameter greater than the first diameter. The plurality of ribs 682 may further include a plurality of additional ribs of gradually increasing diameter. The plurality of different sized ribs 682 and the tapered frustoconical portion 681 allow connection to a plurality of different inner diameters of sample collection tubes 20 without regard to the particular dimensions of the threads or outer diameter of the tubes.

[0073] In the illustrated embodiment, the ribs 682 are radial ribs that extend circumferentially around the frustoconical portion 681. However, in some embodiments, the ribs 682 have a different shape that facilitates a tight mechanical fit with the inside of the sample collection tube. For example, the ribs 682 may extend only partially around the frustoconical portion 681, or may form fins that extend axially along the frustoconical portion 681, or may form a wedge.

[0074] In some embodiments, the tube coupling extension 680 includes one or more rib pairs 683, with the ribs of the rib pair having the same diameter, as shown in FIG. 18. That is, the tube coupling extension 680 may include a first rib pair 683 having two ribs 683A, 683B each extending to the same (first) outer diameter D683. Alternatively, the tube coupling extension 680 may include a rib group including three or more ribs of the same diameter instead of a rib pair. The tube coupling extension 680 may further include a second rib pair having two ribs each extending to the same (second) diameter. The first rib pair 683 may be closest to the distal end 602. The first diameter D683 may be smaller than the second diameter. The tube coupling extension 680 may further include additional rib pairs, with each pair having a successively larger diameter. By having rib pairs (or groups) with the same diameter, rocking or pivoting of the sample collection device 1 , 1 ′ when the tube coupling extension 680 is inserted into the sample collection tube 20 may be prevented or reduced.

[0075] In some embodiments, the housing 50 (e.g., the first element 500) is modified to accommodate sample collection from nasal breath or aerosols alone or in addition to oral breath or aerosols. The flange 520 of the first element 500 may include a notch 550, as shown, for example, in Figures 11B, 13B, 14A, and 14B. The notch 550 may have curved edges so that it can rest against the base of the user's nose. Resting the notch 550 against the base of the nose can help align the airflow pathway 52 with the edges of the nostrils.

[0076] The sample collection system may further comprise a machine-readable optical label. Such labels may include, for example, bar codes and QR (Quick Response) codes. The machine-readable optical label may be configured to identify the device. An electronic reader capable of reading the machine-readable optical label may be used to read and record the results. The electronic reader may be, for example, a smart phone, a tablet, a laptop, or a bar code reader or a QR code reader. The electronic reader may also be used to transmit the results, for example, to a medical professional or to a database.

[0077] A method of using the sample collection system may include blowing into the exhalation piece through either the mouth or nose (while the housing 10 is assembled) to capture a sample in the porous sample collection medium 300, coupling the housing 10 of the sample collection device 1 with the sample collection tube 20, and transferring the sample to the sample collection tube 20. The sample may be transferred by removing the sample collection medium 300 and pushing the sample collection medium 300 into the sample collection tube 20. The sample collection medium 300 may be removed and pushed in using the plunger 30.

[0078] Optionally, the method may include applying a liquid to the porous sample collection medium 300. The liquid may be applied in an amount suitable to elute viruses, pathogens, or other analytes captured in the porous sample collection medium. The suitable amount of liquid may be determined as the ratio of the liquid volume to the surface area of ​​the porous sample collection medium. For example, the volume of liquid may be greater than or equal to 10 μm / cm 2 ~400μm / cm 2 , or 10 μm / cm 2 ~250μm / cm 2 , or 50 μm / cm 2 ~150μm / cm 2 In some embodiments, the volume of the liquid is between 50 μm and 500 μm.

[0079] Optionally, a user may cap either the sample collection device 1 or the sample collection tube 20, or both, after obtaining a sample and transferring the sample to the sample collection tube 20. The sample collection device 1 may be capped for storage or safe disposal. The sample collection tube 20 may be capped for analysis or transport.

[0080] The method may further include vortexing the sample collection tube 20 containing the loaded sample collection medium 30 .

[0081] In another configuration, the kit may include a sample collection device and instructions for collecting a sample on a sample collection medium and transferring the sample collection medium to a sample collection tube. The instructions may include instructions for blowing along an airflow path to capture the sample in the porous sample collection medium, coupling a housing to the sample collection tube, and using a plunger to push the sample collection medium into the sample collection tube coupled to the device. The instructions may further include instructions for reading the optical label using an electronic reader.

[0082] All references and publications mentioned herein are expressly incorporated by reference in their entirety into this disclosure, except where they may directly contradict this disclosure. Although specific embodiments are shown and described herein, those skilled in the art will understand that the specific embodiments shown and described may be replaced by various alternative and / or equivalent embodiments without departing from the scope of this disclosure. It should be understood that this disclosure is not to be unduly limited by the exemplary embodiments and examples described herein, and that such examples and embodiments are presented merely as examples within the scope of this disclosure, which is intended to be limited only by the scope of the claims described herein.

Claims

1. A housing comprising a first element and a second element removably coupled to each other, and an air flow path extending through the first element and the second element, wherein the first element comprises an exhalation piece, and the second element comprises a coupling end constructed to couple with a sample collection tube, the housing; A porous sample collection medium comprising a non-woven material and disposed partially between the first element and the second element and arranged to block the air flow path; Comprising; The second element comprises a coupling mechanism constructed to couple with a sample collection tube; The coupling mechanism; Either a first set of threads, or A frustoconical portion and a plurality of ribs extending from the frustoconical portion, a sample collection device.

2. The sample collection device according to claim 1, wherein each of the first element and the second element comprises a tubular body.

3. The sample collection device according to claim 1 or 2, wherein when the first element and the second element are coupled, the tubular body of the first element is coaxial with the tubular body of the second element.

4. The sample collection device according to claim 1, wherein the second element comprises a shelf portion, the first element comprises a distal end, and when the first element and the second element are coupled, an outer edge of the porous sample collection medium is held between the shelf portion and the distal end.

5. The sample collection device according to claim 1, wherein the non-woven material comprises polylactic acid, polypropylene, or a combination thereof.

6. The sample collection device according to claim 1, wherein the first element and the second element are coupled by a bayonet connection, an interference fit, a snap fit, or a screw connection.

7. The sample collection device according to claim 1, wherein the housing comprises a finger support extending outwardly from a body of the first element or the second element.

8. The sample collection device according to claim 1, wherein the coupling mechanism comprises a second set of threads of a size different from the first set of threads.

9. The sample collection device according to claim 1, wherein the coupling mechanism comprises an angled coupling surface.

10. The sample collection device according to claim 1, wherein the plurality of radial ribs comprises radial ribs.

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