Protected sample collection medium

Abstract

A protected sample collection medium for use in a sample collection device includes a piece of porous sample collection medium having a first major side and an opposing second major side, and a protective sheath completely covering the first major side and the second major side. The protective sheath has a first portion and a second portion. The first portion is removable without removing the second portion. The second portion forms a tab constructed to be grasped by hand. The protected sample collection medium may be part of a system including the sample collection device. The system may be provided as a kit including instructions for using the kit.

Description

[Technical field]

[0001] SUMMARY The present disclosure relates to a sample collection medium for use in sample collection devices and systems.The present disclosure relates to a sample collection medium protected by a removable sheath. [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 nasal cavity, the middle turbinate region of the nasal cavity, 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 a nasal swab and a test kit (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 a purification step when using RT-PCR molecular tests. Summary of the Invention

[0003] There is a need for inexpensive, simple to use, and reliable sample collection devices and systems that can be used by the public to obtain samples for testing for the presence of target viruses, pathogens, or other target analytes in the collected samples. Further, there is a need for sample collection media for use in such devices and systems that can be conveniently and easily stored, transported, and handled while minimizing contamination from the environment or the user.

[0004] The protected sample collection medium of the present invention is suitable for use in a variety of sample collection devices and systems. The sample collection device may include a housing that receives the sample collection medium and promotes deposition of a sample (e.g., a bioaerosol, such as an exhaled airstream sample) on the sample collection medium. The housing may define an airflow path, and the sample collection medium received within the housing may be configured to occlude the airflow path such that viruses, bacteria, or other pathogens within the airstream are captured by the sample collection medium. A sample collection system may include the sample collection device and one or more other instruments that facilitate analysis of the sample. The sample collection system may include a sample collection tube, an assay, or both.

[0005] It is desirable to provide a sample collection medium that is protected from contamination yet easy to use. The protected sample collection medium may advantageously be self-contained and optionally sterile. Self-contained (and optionally sterile) sample collection medium may improve the accuracy and reliability of pathogen testing due to reduced contamination and background noise, unlike media or swabs and other test collection devices that are exposed to the environment and may become contaminated during use and / or testing.

[0006] It is desirable to provide a sample collection medium that provides a means for easily transferring the collected sample, following sample collection, to a sample collection tube or assay without contamination from the user or the environment.

[0007] According to one embodiment, a protected sample collection medium for use in a sample collection device includes a piece of porous sample collection medium having a first major side and an opposing second major side, and a protective sheath completely covering the first and second major sides. The protective sheath has a first portion and a second portion. The first portion is removable without removing the second portion. The second portion forms a tab constructed to be grasped by hand.

[0008] The protective sheath may comprise porous paper, plastic, metal, a nonwoven sheet, or a combination thereof.

[0009] In some embodiments, the first portion of the protective sheath comprises a peelable first side disposed on the first major side of the porous sample collection medium piece and a peelable second side disposed on the first major side of the porous sample collection medium piece.

[0010] In some embodiments, the first and second portions are integral with one another, and the division between the first and second portions may be marked by a notch or perforation.

[0011] The porous sample collection medium may be made of a non-woven material, which may include polylactic acid, polypropylene, or a combination thereof.

[0012] The protected sample collection medium may further include a support frame disposed along the protective sheath or the piece of porous sample collection medium. The support frame may extend along an outer edge of the protective sheath or the piece of porous sample collection medium.

[0013] According to one embodiment, a sample collection system includes a protected sample collection medium and a sample collection device. The sample collection device has an airflow path extending from a first end to a second end and an opening constructed to receive the protected sample collection medium such that the sample collection medium blocks the airflow path. The tab may extend at least partially outside the sample collection device. The sample collection device may have a tubular wall defining a first end and a second end, the first end forming a mouthpiece. The opening may be disposed within the tubular wall. The tubular wall may have a track constructed to guide or support the protected sample collection medium. The sample collection device may be constructed to couple with a sample collection tube via a bayonet coupling, an interference fit, a snap fit, or a threaded coupling.

[0014] According to one embodiment, a kit for collecting a sample may include a sample collection system and instructions for gripping the protected sample collection medium with a second portion, inserting the protected sample collection medium into a sample collection device, blowing along an airflow path to capture a sample in the porous sample collection medium, removing the protected sample collection medium from the sample collection device, and removing the first portion of the protective sheath. The kit may further include instructions for transferring the loaded sample collection medium to a sample collection tube. The kit may further include instructions for eluting the sample from the loaded sample collection medium using a liquid. [Brief description of the drawings]

[0015] [Figure 1A] 1 is a schematic top view of a protected sample collection medium, according to one embodiment. [Figure 1B] 1B is a schematic top view of the sample collection medium of FIG. 1A with a first portion of the protective sheath removed. [Diagram 2] FIG. 2 is a perspective view of a protected sample collection medium with a first portion of the protective sheath partially peeled away, according to one embodiment. [Figure 3A] 1 is a schematic top view of a sample collection medium with a support frame, according to one embodiment. [Figure 3B] 1 is a schematic perspective view of a sample collection medium having a support frame, according to one embodiment. [Figure 4A] 3B is a perspective view of the sample collection medium of FIG. 3A disposed within a sample collection device, according to one embodiment. [Figure 4B] FIG. 4B is a bottom perspective view of the sample collection medium and sample collection device of FIG. 4A. [Figure 4C] 4B is a cross-sectional view of the sample collection medium and sample collection device of FIG. 4A. [Figure 4D] FIG. 4B is a partial cutaway view of the sample collection medium and sample collection device of FIG. 4A. [Figure 4E]FIG. 4B is a perspective view of the sample collection medium and sample collection device of FIG. 4A having a sample collection tube.

[0016] 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.

[0017] Unless otherwise indicated, the terms "polymer" and "polymeric material" include, but are not limited to, organic homopolymers, copolymers (e.g., block copolymers, graft copolymers, random copolymers, alternating copolymers, etc.), 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.

[0018] 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 mouthpiece element and the most downstream element of the device is the exhalation outlet element.

[0019] 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.

[0020] 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."

[0021] 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.

[0022] 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."

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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%.

[0029] 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.

[0030] 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.

[0031] 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

[0032] The present disclosure relates to a sample collection medium for use in sample collection devices and systems. The present disclosure relates to a sample collection medium protected by a removable sheath. The protected sample collection medium may be used in devices and systems for collecting bioaerosol samples.

[0033] In general, the sample collection medium may be used in a sample collection device that includes a housing constructed to receive the sample collection medium. The housing defines an airflow path, and the protected sample collection medium received within the housing is positioned to occlude the airflow path such that viruses, bacteria, or other pathogens in the airflow are captured by the sample collection medium. The sample collection medium may include a porous non-woven material constructed to capture viruses, pathogens, or other analytes carried in the exhaled airstream.

[0034] After loading, the sample collection medium may be transferred to a sample collection tube. The protective sheath may be removed prior to transferring the sample into the sample collection tube. The protective sheath may be configured such that it may be removed and the sample collection medium may be transferred into the sample collection tube without the user's hands touching the sample collection medium. The sample may be further analyzed for the presence of the pathogen of interest or the sample collection tube may be capped and sent to another location for analysis. According to an alternative embodiment, transferring the sample to the sample collection tube may be performed by passing a liquid through the porous sample collection medium to elute the sample containing the pathogens, viruses or other analytes bound to the porous sample collection medium to form an eluent and flowing the eluent into the sample collection tube. The eluent may then be analyzed using known methods.

[0035] According to one embodiment, the protected sample collection medium is easy to use while protecting the sample collection medium from contamination. The protected sample collection medium may advantageously be self-contained and optionally sterile. The protected sample collection medium may improve the accuracy and reliability of pathogen testing by reducing contamination and background noise. The protected sample collection medium provides a means for easy transfer of collected samples to sample collection tubes or assays while reducing contamination from the user or the environment.

[0036] According to one embodiment, the protected sample collection medium includes a piece of porous sample collection medium covered by a removable protective sheath. The porous sample collection medium may be a flat sheet having a first major side and an opposing second major side. The protective sheath completely covers the first major side and the second major side. The protective sheath has a first portion and a second portion, the first portion being removable without removing the second portion. The second portion forms a tab constructed to be grasped by hand. The second portion covers only a portion of the porous sample collection medium. For example, the second portion may cover 50% or less, 40% or less, 30% or less, or 20% or less of the length of the porous sample collection medium.

[0037] The protective sheath may be made from a single sheet of material that encases both major sides of the porous sample collection medium. The protective sheath may be made from two sheets of material that are applied over the porous sample collection medium and bonded together along their edges. The protective sheath may be made from two or more sheets of material to provide the first and second portions.

[0038] In some embodiments, the first and second portions of the protective sheath are integral with one another. In such embodiments, the first portion may be removed by tearing. The division between the first and second portions may be marked by a notch or perforation. A user may grasp the protected sample collection medium by the second portion and tear and remove the first portion along the notch or perforation, leaving the grasped end of the porous sample collection medium covered by the second portion.

[0039] In some embodiments, the first portion of the protective sheath has a peelable first side disposed on the first major side of the porous sample collection medium piece and a peelable second side disposed on the second major side of the porous sample collection medium piece, A user may remove the first portion by peeling the first side and then removing or peeling the second side, leaving the second portion in place.

[0040] The protective sheath may be made of any suitable material. For example, the protective sheath may be made of paper, plastic, metal, a nonwoven sheet, or a combination thereof. The protective sheath may be made of a laminated or coated porous material, such as plastic-treated paper, metal-treated paper, metal-treated plastic, etc. In some embodiments, the protective sheath may be made of a nonwoven material. The nonwoven material may include polylactic acid, polypropylene, or a combination thereof. The nonwoven material may have a suitable thickness and strength to provide protection to the porous sample collection medium before the first portion is removed, but also to allow the first portion to be easily removed, for example by tearing.

[0041] The protective sheath may act as a pre-filter or screen that covers the porous sample collection medium during sample collection. The protective sheath may trap larger particles (larger than viruses or pathogens) and prevent such particles from reaching the porous sample collection medium. The exhaled airflow passes through the thickness of the protective sheath. In some cases, the protective sheath may be a non-woven layer that does not have a static charge. In some embodiments, the protective sheath does not trap significant amounts of viral, pathogen or other analyte material, but rather allows them to permeate through the protective sheath. According to one embodiment, the protective sheath is removed from the porous sample collection medium before transferring the porous sample collection medium to a sample collection tube or test tube for analysis.

[0042] The porous sample collection medium may be provided in any shape and size depending on the intended use. In some embodiments, the porous sample collection medium is made of a flat sheet of material. However, other configurations are also contemplated, so long as the porous sample collection medium can be protected by a protective sheath as described and can be inserted into a sample collection device. Although the porous sample collection medium is illustrated here as a rectangular or substantially rectangular flat element, it is understood that the porous sample collection medium may define any shape for placement along the airflow path within the housing. The shape and size of the porous sample collection medium may be selected based on the shape and size of the interior of the sample collection device.

[0043] 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).

[0044] 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.

[0045] 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.

[0046] In some embodiments, the protected sample collection medium is supported by a frame. The frame may facilitate insertion of the protected sample collection medium into the sample collection device. The support frame may be disposed along the protected sample collection medium. The support frame may extend along the outer edge of the protective sheath or the piece of porous sample collection medium. The support frame may be adhered to the protective sheath or the porous sample collection medium by an adhesive. According to one embodiment, the support frame is adhered to the protective sheath.

[0047] The protected sample collection medium is configured for use in a sample collection device. For example, the protected sample collection medium may be configured for use in a sample collection device described in U.S. Provisional Patent Application No. 63 / 200,058, U.S. Provisional Patent Application No. 63 / 200,901, U.S. Provisional Patent Application No. 63 / 202,140, ​​U.S. Provisional Patent Application No. 63 / 200,958, U.S. Provisional Patent Application No. 63 / 201,981, U.S. Provisional Patent Application No. 63 / 202,143, U.S. Provisional Patent Application No. 63 / 201,983, or U.S. Provisional Patent Application No. 63 / 203,442, filed concurrently with this disclosure. In general, the protected sample collection medium is configured for use in a sample collection device having a housing that defines an airflow path. The protected sample collection medium may be placed (e.g., inserted) in the housing and positioned to block the airflow path. The housing may be modified to include an opening for inserting a protected sample collection medium. A user may breathe into the sample collection device to load the porous sample collection medium with a sample of the exhaled airstream to form a loaded porous sample collection medium. The user may breathe through the opening, for example, through a mouthpiece. The housing is constructed such that breathing through an opening in the mouthpiece causes at least a portion of the exhaled airstream to pass through the porous sample collection medium. The user may optionally transfer the loaded sample collection medium into a sample collection tube. Alternatively, the user may elute the sample from the loaded sample collection medium directly onto a sample collection tube or assay.

[0048] In some embodiments, the protected sample collection device is configured for insertion of a porous sample collection medium into the sample collection device and airflow path. The sample collection device may have a housing defining an airflow path extending from a first end to a second end, and an opening constructed to receive the protected sample collection medium such that the porous sample collection medium blocks the airflow path. A user may insert the protected sample collection medium (porous sample collection medium covered by a protective sheath) into the airflow path through the opening. When the protected sample collection medium is inserted into the sample collection device, a portion (e.g., a tab) of the protected sample collection medium extends outside the sample collection device. The sample collection device may include various features to facilitate insertion of the protected sample collection medium, as discussed further below. A user may breathe through the sample collection device to capture a sample of exhaled air in the porous sample collection medium. The protected sample collection medium may then be removed from the sample collection device. The protected sample collection medium may be gripped by the tab (a second portion of the protective sheath). The first portion of the protective sheath may be removed (e.g., by tearing or peeling) leaving the second portion covering a portion (e.g., a tab) of the sample collection medium. In some embodiments, the first portion of the protective sheath may remain in the sample collection device. The loaded sample collection medium may then be transferred to a sample collection tube.

[0049] The protected sample collection medium and sample collection device may be provided as a complete system for collecting samples from exhaled breath, which may further include other parts, such as a sample collection tube for receiving the loaded sample collection medium, or an assay for testing the loaded sample collection medium for the presence of pathogens or other analytes.

[0050] According to one embodiment, the housing has a proximal end and an opposite distal end. The distal end may be constructed to mate with a sample collection tube. The distal end may include any suitable mechanism for mating with a sample collection tube. For example, the distal end may be constructed for a bayonet mating, interference fit, snap fit, or threaded mating. Many commercially available sample collection tubes or test tubes have threaded tops for attaching a cap. The distal end of the sample collection device may be constructed to mate with the threads of the sample collection tube. The distal end of the sample collection device may include female threads configured to mate with the male threads of the sample collection tube. In some embodiments, the distal end is configured for an interference fit with the sample collection tube.

[0051] Transferring the loaded sample collection medium into the sample collection tube may be performed by removing the protected sample collection medium from the sample collection device, removing the protective sheath (e.g., the first portion or both the first and second portions), and allowing the loaded sample collection medium to drop into the tube.

[0052] Transferring the loaded sample collection medium into the sample collection tube may be performed by pushing into the tube with a plunger while the sample collection tube is coupled to the sample collection device, hi some embodiments, the plunger is a rod configured to fit through the airflow channel.

[0053] 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.

[0054] 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 be collected and tested.

[0055] 1A and 1B, a schematic diagram of a protected sample collection medium 30 is shown. The protected sample collection medium 30 includes a sample collection medium piece 310 protected by a removable sheath 350. The sample collection medium 310 may be in the form of a rectangular piece of material, as shown, or may be of any other suitable shape desired. The illustrated sample collection medium 310 has a first major side 311 and an opposing second major side 312. The protective sheath 350 completely covers the first major side 311 and the second major side 312. The protective sheath 350 includes a first side 351 that covers the first side 311 of the sample collection medium 310 and a second side 352 that covers the second side 312 of the sample collection medium 310.

[0056] The sample collection medium 310 has a first end 315 and an opposite second end 316. The protective sheath 350 defines a first portion 355 and a second portion 356. The first portion 355 of the protective sheath 350 covers the first end 315 of the sample collection medium and the second portion 356 covers the second end 316. According to one embodiment, the first portion 355 is removable without removing the second portion 356. If desired, the second portion 356 may also be removed.

[0057] The first portion 355 and the second portion 356 of the protective sheath 350 may be integral with one another. The sheath 350 may include a notch 357 between the first portion 355 and the second portion 356. Alternatively, the sheath 350 may include a perforation between the first portion 355 and the second portion 356. A user may grasp the protected sample collection medium 30 by the second portion 356 and tear and peel away the first portion 355 along the notch (or perforation), leaving the second end 316 of the porous sample collection medium 310 covered by the second portion 356.

[0058] The second portion 356 forms a tab 360 that is constructed to be manually grasped. The second portion 356 covers only a portion of the sample collection medium 310. For example, the second portion 356 may cover 50% or less, 40% or less, 30% or less, or 20% or less of the length L310 of the sample collection medium 310.

[0059] In an alternative embodiment, the sample collection medium 310 is protected by a peelable sheath 370, as shown in FIG. 2. The peelable sheath 370 includes a first portion 375 and a second portion 376. The first portion 375 has a peelable first side 371 disposed on the first major side 311 of the sample collection medium 310 and a peelable second side 372 disposed on the second major side 312 of the sample collection medium 310. A user may remove the first portion 375 by peeling the first side 371 and then removing or peeling the second side 372, leaving the second portion 376 in place. The second portion 376 forms a tab 380 constructed to be grasped by hand. The second portion 376 covers only a portion of the sample collection medium 310. For example, the second portion 376 may cover 50% or less, 40% or less, 30% or less, or 20% or less of the length L310 of the sample collection medium 310.

[0060] 3A and 3B, the protected sample collection medium 30 is supported by a frame 390. The frame 390 may facilitate insertion of the protected sample collection medium 30 into the sample collection device 1. The support frame 390 may be disposed along an outer edge 303 of the protective sheath 350 or the sample collection medium 310. The support frame 390 may be adhered to the protective sheath 350 or the sample collection medium 310 by an adhesive.

[0061] 4A-4D, a protected sample collection medium 30 may be placed (e.g., inserted) within the housing 10 of the sample collection device 1. The sample collection medium 310 may be configured to occlude the airflow path 20 extending through the housing 10.

[0062] The exemplary sample collection device 1 has a housing 10 with a tubular wall 14. The tubular wall 14 defines a first end 11 and a second end 12, and an airflow path 20 extending through the tubular wall 14. The first end 11 may form a mouthpiece 18 having an opening 19 to the airflow path 20. The housing 10 has a central longitudinal axis A10. In the illustrated embodiment, the airflow path 20 extends along the central longitudinal axis A10 of the housing 10. The protected sample collection medium 30 is disposed within the housing 10 such that the sample collection medium 310 blocks the airflow path 20. The tubular wall 14 of the housing 10 has an opening 13 for inserting the protected sample collection medium 30. The opening 13 may be a slot in the tubular wall 14. The slot (opening 13) may be disposed at an angle that is not perpendicular to the longitudinal axis A10 of the housing 10. The slot may be disposed at an angle that is not perpendicular to the airflow path 20. In some embodiments, the opening may be formed by a gap between two portions of the tubular wall. The outer edge 303 of the protected sample collection medium 30 may extend along the inner surface 15 of the tubular wall 14 or may extend into a groove 16 in the inner surface 15.

[0063] The housing 10 may include tracks 17 for supporting one or more edges 303 of the protected sample collection medium 30. In the illustrated embodiment, the housing 10 has two tracks 17 on the interior or opposite sides of the housing 10. The two tracks 17 are angled relative to the central longitudinal axis A10 of the housing 10 and therefore relative to the airflow path 20. This increases the surface area of ​​the sample collection medium 310 exposed to the exhaled airflow. In some embodiments, the two tracks 17 extend inwardly from the inner surface 15 of the housing. The tracks 17 may form a groove 16 along the inner surface 15 of the housing.

[0064] In embodiments in which the protected sample collection medium 30 is supported by a frame 390, the frame 390 may be inserted into a groove 16 in the track 17 to guide the sample collection medium 310 into position.

[0065] A user may insert the protected sample collection medium 30 into the opening 13 in the sample collection device 1. The second end 316 of the sample collection medium 310 and the second portions 352, 372 of the protective sheaths 350, 370 form tabs 360, 380 constructed to be manually grasped. The tabs 360, 380 may extend at least partially to the exterior of the sample collection device 1 (e.g., outside the tubular wall 14). The sample collection device 1 may include various features to facilitate insertion of the sample collection medium, as discussed above.

[0066] A user may breathe into the sample collection device 1 to load the sample collection medium 310 with a sample of the exhaled airflow to form a loaded porous sample collection medium. A user may breathe through the opening 19 in the mouthpiece 18. The housing 10 is constructed such that breathing through the opening 19 in the mouthpiece 18 causes at least a portion of the exhaled airflow to pass through the sample collection medium 310.

[0067] A user may optionally transfer the sample into the sample collection tube 200 shown in FIG. 4E. After loading the sample into the sample collection medium 310, the user may remove the protected sample collection medium 30 from the device 1 and prepare the sample collection medium 310 for transfer into the sample collection tube 200 by removing the first portions 351, 371 of the protective sheaths 350, 370 leaving the second portions 352, 372 to cover a portion of the sample collection medium 310 (e.g., tabs 360, 380). The first portions 351, 371 of the protective sheaths 350, 370 may remain within the opening 13 of the sample collection device 1 as the protected sample collection medium 30 is pulled out of the opening 13 by the tabs 350, 380. The sample transfer may be performed by transferring the loaded sample collection medium 310 into the sample collection tube 200, for example, by holding the loaded sample collection medium 310 by the tabs 360, 380 and placing the loaded sample collection medium 310 into the sample collection tube 200. The user may further remove the second portion 352, 372 from the tabs 360, 380 while leaving the sample collection medium 310 in the sample collection tube 200. Alternatively, the sample transfer may be performed by eluting the sample with a suitable eluent. The eluent may be applied through the airflow path 20.

[0068] Optionally, the method of using the sample collection medium 310 may include applying a liquid to the loaded sample collection medium 310. The liquid may be applied in an amount suitable to elute viruses, pathogens, or other analytes captured in the porous sample collection medium 310. A suitable amount of liquid may be determined as the ratio of the liquid volume to the surface area of ​​the sample collection medium 310. 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.

[0069] The method may further include vortexing the sample collection tube containing the loaded sample collection medium 310.

[0070] The protected sample collection medium may be provided as part of a sample collection system. The system may include a sample collection device and a protected sample collection medium for use with the sample collection device. The system may further include a sample collection tube, as shown in FIG. 4E, into which a sample obtained using the sample collection device and the protected sample collection medium may be transferred.

[0071] The protected sample collection medium may be provided as part of a kit. The kit may include a sample collection device, a protected sample collection medium, and instructions for collecting a sample in the sample collection medium. The instructions may include instructions for gripping the protected sample collection medium by the second portion, inserting the exposed sample collection medium into the sample collection device, blowing along the airflow path to capture the sample in the porous sample collection medium, removing the protected sample collection medium from the sample collection device, removing the first portion of the protective sheath, transferring the loaded sample collection medium to a sample collection tube or using a liquid to elute the sample from the loaded sample collection medium.

[0072] Exemplary embodiments Below is a list of exemplary embodiments according to the present disclosure.

[0073] Embodiment 1 is a protected sample collection medium for use in a sample collection device, the protected sample collection medium comprising a piece of porous sample collection medium having a first major side and an opposing second major side, and a protective sheath completely covering the first and second major sides. The protective sheath comprises a first portion and a second portion. The first portion is removable without removing the second portion, and the second portion forms a tab constructed to be grasped by hand.

[0074] Embodiment 2 is the protected sample collection medium of embodiment 1, further comprising a support frame disposed along the protective sheath or the piece of porous sample collection medium. The frame may be adhered to the protective sheath or the piece of porous sample collection medium by an adhesive.

[0075] Embodiment 3 is the protected sample collection medium of embodiment 2, where the support frame extends along the outer edge of the protective sheath or piece of porous sample collection medium.

[0076] Embodiment 4 is the protected sample collection medium of any one of embodiments 1-3, wherein the protective sheath comprises paper, plastic, metal, a nonwoven sheet, or a combination thereof. The protective sheath may be made of a laminated or coated porous material, such as plastic-treated paper, metal-treated paper, metal-treated plastic, etc. The protective sheath may be made of a nonwoven material. The nonwoven material may comprise polylactic acid, polypropylene, or a combination thereof.

[0077] Embodiment 5 is the protected sample collection medium of any one of embodiments 1-4, wherein the protective sheath acts as a pre-filter or screen that covers the porous sample collection medium during sample collection.

[0078] Embodiment 6 is the protected sample collection medium of any one of embodiments 1 to 5, wherein the first portion of the protective sheath includes a peelable first side disposed on the first major side of the porous sample collection medium piece and a peelable second side disposed on the first major side of the porous sample collection medium piece.

[0079] Embodiment 7 is the protected sample collection medium of any one of embodiments 1-4, wherein the first portion and the second portion are integral with each other.

[0080] Embodiment 8 is the protected sample collection medium of any one of embodiments 1-5 and 7, wherein the division between the first and second portions is marked by a notch or perforation.

[0081] Embodiment 9 is the protected sample collection medium of any one of embodiments 1-8, wherein the porous sample collection medium comprises a nonwoven material.

[0082] Embodiment 10 is the protected sample collection medium of embodiment 9, wherein the nonwoven material comprises polylactic acid, polypropylene, or a combination thereof.

[0083] Embodiment 11 is a sample collection system comprising the protected sample collection medium of any one of the preceding embodiments and a sample collection device, the sample collection device comprising an airflow path extending from a first end to a second end and an opening constructed to receive the protected sample collection medium such that the piece of porous sample collection medium blocks the airflow path and such that the tab extends at least partially outside the sample collection device.

[0084] Embodiment 12 is the sample collection system of embodiment 11, wherein the opening comprises a slot.

[0085] Embodiment 13 is the sample collection system of embodiment 12, wherein the slot is disposed at an angle that is not perpendicular to the airflow path.

[0086] Embodiment 14 is the sample collection system of any one of embodiments 11-12, wherein the sample collection device comprises a tubular wall defining a first end and a second end, the first end forming a mouthpiece.

[0087] Embodiment 15 is the sample collection system of embodiment 14, wherein the opening is an opening in the tubular wall.

[0088] Embodiment 16 is the sample collection system of embodiment 15, wherein the opening is formed between two portions of the tubular wall.

[0089] Embodiment 17 is the sample collection system of any one of embodiments 12 to 16, wherein the tubular wall comprises a track on an inner surface of the tubular wall constructed to guide or support the protected sample collection medium.

[0090] Embodiment 18 is the sample collection system of any one of embodiments 12-17, wherein the tubular wall comprises a groove on an inner surface of the tubular wall constructed to guide or support the protected sample collection medium.

[0091] Embodiment 19 is the sample collection system of any one of embodiments 11 to 18, wherein the sample collection device is constructed to couple with the sample collection tube via a bayonet coupling, an interference fit, a snap fit, or a threaded coupling.

[0092] Embodiment 20 is a kit for collecting a sample, the kit comprising the sample collection system of any one of embodiments 11 to 19 and instructions for grasping the protected sample collection medium with the second portion, inserting the exposed sample collection medium into a sample collection device, blowing along the airflow path to capture a sample in the porous sample collection medium, removing the protected sample collection medium from the sample collection device, and removing the first portion of the protective sheath.

[0093] Embodiment 21 is the kit of embodiment 20, further comprising instructions for transferring the loaded sample collection medium to a sample collection tube. The instructions may further comprise instructions for removing the second portion of the protective sheath prior to placing the loaded sample collection medium in the sample collection tube.

[0094] Embodiment 22 is the kit of embodiment 20 or 21, further comprising instructions for eluting the sample from the loaded sample collection medium using a liquid.

[0095] 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 protected sample collection medium for use in a sample collection device, comprising: A porous sample collection medium piece having a first main side and an opposing second main side; A protective sheath that completely covers the first main side and the second main side, the protective sheath comprising a first portion and a second portion, the first portion being removable without removing the second portion, the second portion forming a tab configured to be gripped by hand; A protected sample collection medium comprising the above.

2. The protected sample collection medium according to claim 1, further comprising a support frame disposed along the protective sheath.

3. The protected sample collection medium according to claim 2, wherein the support frame extends along the outer edge of the protective sheath.

4. The protected sample collection medium according to claim 1, wherein the protective sheath comprises paper, plastic, metal, non-woven sheet, or a combination thereof.

5. The protected sample collection medium according to claim 1, wherein the first portion of the protective sheath comprises a peelable first side disposed on the first main side of the porous sample collection medium piece and a peelable second side disposed on the first main side of the porous sample collection medium piece.

6. The protected sample collection medium according to claim 1, wherein the first portion and the second portion are integrated with each other.

7. The protected sample collection medium according to claim 1, wherein the separation between the first portion and the second portion is marked by a notch or a perforation.

8. The protected sample collection medium according to claim 1, wherein the porous sample collection medium comprises a non-woven material.

9. The protected sample collection medium according to claim 8, wherein the non-woven material comprises polylactic acid, polypropylene, or a combination thereof.

10. A sample collection system comprising the protected sample collection medium according to claim 1; A sample collection device, comprising an air flow path extending from a first end to a second end, and an opening configured to receive the protected sample collection medium such that the porous sample collection medium piece closes the air flow path and the tab extends at least partially outside the sample collection device. A sample collection system comprising the above.

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