Sample collection devices and systems

Abstract

The sample collection device includes a housing extending from a mouthpiece portion to an air outlet portion. The housing defines an airflow channel from the mouthpiece portion to the air outlet portion. The mouthpiece portion is configured to receive the exhaled airflow. A porous sample collection medium is disposed within the housing along the airflow channel. A fluid inlet port defines an opening through the housing and is adjacent to the porous sample collection medium. The fluid inlet port is configured to direct a fluid onto the porous sample collection medium. A metered fluid dosage element is attached to the fluid inlet port. The metered fluid dosage element is configured to dispense a metered volume of fluid into the fluid inlet port.

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 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 an inexpensive, easy to use, reliable sample collection device that can be used to test the general population worldwide to see if they are shedding pathogens or viruses, which can be paired with a testing device to determine the presence or absence of the pathogen or virus in the collected sample.

[0004] The sample collection device includes a porous sample collection medium disposed within a device housing along an airflow channel defined by the device housing. A metered volume of fluid passes through the porous sample collection medium, carrying away pathogens or viruses bound to the porous sample collection medium. The metered volume of fluid can then be analyzed. The metered volume of fluid can be attached or replaceably attached to the housing, and the metered volume of fluid can be transferred through the device housing and onto the porous sample collection medium.

[0005] It may be desirable to provide a system that includes both a sample collection device and a rapid antigen test in a single device. The integrated device may advantageously be self-contained and sterile (unlike swabs, which may become contaminated during use and then become more contaminated during testing, increasing background noise during testing) so that pathogen or virus detection may be more accurate or reliable. [Brief description of the drawings]

[0006] [Figure 1] 1 is a front perspective schematic diagram of an exemplary sample collection device and system.

[0007] [Diagram 2] 2 is a schematic rear perspective view of the sample collection device of FIG. 1.

[0008] [Diagram 3] FIG. 2 is a schematic side view of the sample collection device of FIG. 1.

[0009] [Figure 4] 1 is a rear perspective schematic diagram of another exemplary sample collection device.

[0010] [Diagram 5] FIG. 5 is a schematic side view of the sample collection device of FIG. 4.

[0011] [Figure 6] FIG. 5 is a front schematic view of the sample collection device of FIG. 4.

[0012] [Figure 7] FIG. 6 is a cross-sectional schematic diagram of the sample collection device of FIG. 5.

[0013] [Figure 8] 1 is a rear perspective schematic diagram of another exemplary sample collection device.

[0014] [Figure 9] FIG. 9 is a schematic side view of the sample collection device of FIG. 8.

[0015] [Figure 10] FIG. 10 is a cross-sectional schematic diagram of the sample collection device of FIG.

[0016] [Figure 11] 1 is a rear perspective schematic view of another exemplary sample collection device having a removable mouthpiece.

[0017] [Figure 12] FIG. 12 is a schematic side view of the sample collection device of FIG.

[0018] [Figure 13] FIG. 13 is a cross-sectional schematic diagram of the sample collection device of FIG. 12.

[0019] [Figure 14] 1 is a rear perspective schematic view of another exemplary sample collection device having a removable fluid collection receptacle.

[0020] [Figure 15] FIG. 15 is a schematic side view of the sample collection device of FIG. 14.

[0021] [Figure 16] FIG. 16 is a cross-sectional schematic diagram of the sample collection device of FIG.

[0022] 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.

[0023] The term "substantially" as used herein has the same meaning as "significantly" and can be understood to modify the term that follows by at least about 90%, at least about 95%, or at least about 98%. The term "not substantially" as used herein has the same meaning as "not significantly" and can be understood to have the opposite meaning of "substantially", i.e., modifying the term that follows by 10% or less, 5% or less, or 2% or less.

[0024] 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 "about" and to cover typical margins of error, such as ±5% of the stated value.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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 properties of the composition, product, method, and the like.

[0030] 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.

[0031] Any directions referred to herein, such as "front", "back", "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.

[0032] The terms "downstream" and "upstream" refer to relative locations based on the direction of exhaled airflow through the device. For example, the most upstream element of the device is the mouthpiece element and the most downstream element of the device is the exhalation outlet element. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] FIELD OF THE DISCLOSURE The present disclosure relates to sample collection devices and systems. FIELD OF THE DISCLOSURE The present disclosure relates to bioaerosol collection devices and systems.

[0034] The sample collection device includes a porous sample collection medium disposed within a device housing along an airflow channel defined by the device housing. A metered volume of fluid passes through the porous sample collection medium, carrying away pathogens or viruses that may be bound to the porous sample collection medium. The metered volume of fluid can then be analyzed. The metered volume of fluid can be attached to the housing, and the metered volume of fluid can be transferred through the device housing and onto the porous sample collection medium.

[0035] In particular, the present disclosure relates to a sample collection device that includes a housing extending from a mouthpiece or exhaled breath receiving portion to an air outlet portion. The housing defines an airflow channel from the mouthpiece portion to the air outlet portion. The mouthpiece or exhaled breath receiving portion is configured to receive an exhaled airflow from one or more of the mouth or nose. For example, the mouthpiece or exhaled breath receiving portion can be breathed in by contact with the mouth or by contact with the nose / nostrils, or by contacting each individually or collectively. The exhaled airflow received by the mouthpiece or exhaled breath receiving portion can be one or both of mouth exhalation or nose exhalation. As used herein, the term "mouthpiece" is meant to refer to an exhaled breath receiving portion that can receive an aerosol exhaled from the mouth or nose.

[0036] A porous sample collection medium is disposed within the housing along the airflow channel. A fluid inlet port defines an opening through the housing and is adjacent to the porous sample collection medium. The fluid inlet port is configured to direct a fluid onto the porous sample collection medium. A metered fluid dosing element is attached to the fluid inlet port. The metered fluid dosing element is configured to dispense a metered volume of fluid into the fluid inlet port.

[0037] The porous sample collection medium may be disposed or fixed along the airflow channel. The porous sample collection medium may be replaceable and may be replaced by a user, as needed. For example, a user may exhale into the sample collection device and load the porous sample collection medium with a sample of the exhaled airflow to form a loaded porous sample collection medium. The user may then test the loaded porous sample collection medium. The test may be performed with the loaded porous sample collection medium in place in the sample collection device, or the user may remove the loaded porous sample collection medium from the sample collection device for testing. The user may then replace the loaded porous sample collection medium with an unloaded porous sample collection medium and place it into the sample collection device. Although the porous sample collection medium is shown herein as defining a planar element, it is understood that the porous sample collection medium may define any shape when disposed along the airflow channel within the housing.

[0038] The metered fluid dosage element may be attached to the fluid inlet port. The metered fluid dosage element may be permanently attached to the fluid inlet port. In some embodiments, the metered fluid dosage element may be integral with the fluid inlet port. The metered fluid dosage element may be removably attached to the fluid inlet port. In some embodiments, the metered fluid dosage element may be a replaceable element onto the fluid inlet port.

[0039] The metered fluid dosage element may extend at a right angle from the housing, as shown in Figures 1 to 10. Alternatively, the metered fluid dosage element may extend from the housing at any angle.

[0040] The metered fluid dosage element can define any shape. The metered fluid dosage element can define a cap or end cap shape, such as those shown in Figures 1-10, that expels fluid from the metered fluid dosage element as the metered fluid dosage element moves toward the housing.

[0041] The metered fluid dosage element may be deformable and configured to expel fluid from the metered fluid dosage element when a user squeezes a deformable surface of the metered fluid dosage element.

[0042] The mouthpiece portion and the air outlet portion may integrally form a unitary housing, or one or both of the mouthpiece portion and the air outlet portion may be separate bodies that can be detached from the other portions of the housing.

[0043] Fluid may be deployed through the fluid inlet port and applied onto the loaded porous sample collection medium. The fluid may migrate through the surface and thickness of the loaded porous sample collection medium and flow out of the porous sample collection medium carrying any viruses or pathogens that were present on the loaded porous sample collection medium. This loaded fluid may then be collected and tested as described herein.

[0044] The sample collection device may include a pressing element configured to apply pressure onto the loaded porous sample collection medium, which may push remaining fluid out of the loaded porous sample collection medium for collection and testing. The pressing element may be attached to a metered fluid dosing element, where movement of the metered fluid dosing element actuates the pressing element onto the loaded porous sample collection medium.

[0045] According to one embodiment, a sample collection system includes the sample collection device described above and an assay configured to receive fluid from the fluid collection receptacle.

[0046] The assay may be a separate entity from the sample collection device. The assay may be configured to be attached to the sample collection device. The sample collection device may include a receptacle for receiving at least a portion of the assay. The sample collection device may include a receptacle for receiving the entire assay. The assay may be an exchange entity with the sample collection device.

[0047] The assay may be integral with the sample collection device.The assay may form an integral element with the housing of the sample collection device.

[0048] According to another embodiment, the method includes flowing exhaled breath through a porous sample collection medium disposed within an airflow channel forming a loaded porous sample collection medium, then flowing a metered volume of fluid through the loaded porous sample collection medium disposed within the airflow channel to form an eluate, and collecting the eluate, which can then be tested using an assay.

[0049] FIG 1 shows a front perspective schematic view of an exemplary sample collection device 100 and system 200. The housing 110 in these views is transparent for illustrative purposes only. FIG 2 shows a rear perspective schematic view of the sample collection device 100 of FIG 1. FIG 3 shows a side schematic view of the sample collection device 100 of FIG 1.

[0050] The sample collection device 100 includes a housing 110 extending from a mouthpiece portion 112 to an air outlet portion 114. The housing 110 defines an airflow channel 116 from the mouthpiece portion 112 to the air outlet portion 114. The mouthpiece portion 112 is configured to receive an exhaled airflow 115. A porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. A fluid inlet port 130 defines an opening through the housing 110 and is adjacent to the porous sample collection medium 120. The fluid inlet port 130 is configured to direct a fluid onto the porous sample collection medium 120. A metered fluid dosage element 140 is attached to the fluid inlet port 130. The metered fluid dosage element 140 is configured to dispense a metered volume of fluid into the fluid inlet port 130.

[0051] The housing 110 may be formed from a rigid material such as plastic. The airflow channel 116 may extend from an opening in the mouthpiece portion 112 to an air outlet portion 114 having one or more air outlets. The user exhales into the opening in the mouthpiece portion 112, and the exhaled airflow 115 exits the sample collection device 100 through one or more air outlets in the air outlet portion 114. The airflow channel 116 may extend longitudinally along a longitudinal axis of the housing 110, as shown in Figures 1, 2, and 3. Alternatively, the airflow channel 116 may extend coaxially along a central longitudinal axis of the housing 110.

[0052] The porous sample collection medium 120 may be fixed within the housing 110 along the airflow channel 116. The exhaled airflow 115 passes through a thickness of the porous sample collection medium 120. The porous sample collection medium 120 at least partially occludes the airflow channel 116. The porous sample collection medium 120 may occlude the airflow channel 116. The porous sample collection medium 120 may have a major plane that is orthogonal to the direction of the exhaled airflow 115 passing through the thickness of the porous sample collection medium 120.

[0053] The porous sample collection medium 120 is shown as having a major plane that forms an angle with the direction of the incoming exhaled airflow 115 through the thickness of the porous sample collection medium 120. This angle may be in the range of about 91 degrees to about 179 degrees, or in the range of about 100 degrees to about 160 degrees, or in the range of about 115 degrees to about 150 degrees, or in the range of about 125 degrees to about 145 degrees.

[0054] The porous sample collection medium 120 may be a nonwoven material configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a nonwoven material having an electrostatic charge configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a hydrophobic nonwoven material configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a hydrophobic nonwoven material having an electrostatic charge configured to filter pathogens or viruses from the exhaled airstream 115.

[0055] The term "hydrophobic" refers to a material that has a water contact angle of 90 degrees or greater, or from about 90 degrees to about 170 degrees, or from about 100 degrees to about 150 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.

[0056] The porous sample collection medium 120 may be formed from a polymeric material. The porous sample collection medium 120 may be formed from a polyolefin. The porous sample collection medium 120 may be formed from a polypropylene. One exemplary porous sample collection medium 120 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).

[0057] The porous sample collection medium may be formed from polylactide (PLA), such as, for example, 6100D from NatureWorks LLC 15305 Minnetonka Blvd Minnetonka, MN 55345. Exemplary nonwoven filtration layer materials for use in or as the porous sample collection medium include those described in, for example, U.S. Patent Nos. 7,947,142, 8,162,153, 9,139,940, and 10,273,612, all of which are incorporated herein in their entireties.

[0058] The sample collection medium may be pleated. In some embodiments, the pleat frequency is from about 1 pleat per 0.6 cm of medium to about 1 pleat per 2 mm of medium. In some embodiments, the pleat height is from about 2 mm to about 4 mm.

[0059] The porous sample collection medium 120 may have a thickness (orthogonal to the major plane) in the range of 200 to 1000 micrometers, or 250 to 750 micrometers. 2 ~about 4cm 2 , or about 2 cm 2 ~about 3cm 2 The surface area of ​​the major planar surface may be in the range of 0.1 to 1.0 mm.

[0060] The porous sample collection medium 120 may be secured directly to the housing 110. FIG. 3 shows a support element 125 in contact with and supporting the porous sample collection medium 120. The support element 125 includes one or more openings configured to allow the exhaled airflow to pass through the support element 125. The support element 125 may be secured to the housing 110 and disposed within the airflow channel 116. The porous sample collection medium 120 may be secured directly to the support element 125.

[0061] The metered fluid dosage element 140 may be attached to the fluid inlet port 130 and may be movable between a first fluid-loading position and a second fluid-depleting position, which may be closer to the housing than the first fluid-loading position. In the first fluid-loading position, the metered fluid dosage element 140 contains a metered volume of fluid, and in the second fluid-depleting position, the metered fluid dosage element 140 delivers a metered volume of fluid into the fluid inlet 130 and onto the porous sample collection medium 120. Figure 3 shows the metered fluid dosage element 140 in the second fluid-depleting position.

[0062] The metered fluid dosage element 140 may include a fluid reservoir of the fluid. The metered fluid dosage element 140 may define a volume configured to hold a fluid reservoir of the fluid and release the fluid reservoir of the fluid when the metered fluid dosage element 140 moves from a first fluid-loaded position to a second fluid-depleted position. The metered fluid dosage element 140 may include a plunger element (described below) that moves into the volume configured to hold a fluid reservoir of the fluid and release the fluid reservoir of the fluid when the metered fluid dosage element 140 moves from a first fluid-loaded position to a second fluid-depleted position. One exemplary metered fluid dosage element 140 is commercially available under the trade name CUROS from 3M Company, St. Paul MN, USA.

[0063] The fluid inlet port 130 can define a protrusion extending from an exterior surface of the housing 110. The metered fluid dosage element 140 can define a cap movably attached to the protrusion between a first, fluid-loaded position and a second, fluid-depleted position.

[0064] The porous sample collection medium 120 defines a major surface area value and the fluid reservoir 142 defines a volume value, where the volume value divided by the surface area value is 10 microliters / cm. 2 ~400 microliters / cm 2 , or 10 microliters / cm 2 ~250 microliters / cm 2 , or 50 microliters / cm 2~150 microliters / cm 2 In some embodiments, the fluid reservoir 142 defines a volume in the range of 50 microliters to 500 microliters.

[0065] The metered fluid dosage element 140 may be movably attached to the fluid inlet port 130 via a threaded connection. Thus, the metered fluid dosage element 140 may be moved between a first, fluid-loaded position and a second, fluid-depleted position by rotating the metered fluid dosage element 140 about the threaded axis.

[0066] The fluid dispensed by the metered fluid dosing element 140 may be an aqueous fluid. The fluid dispensed by the metered fluid dosing element 140 may be an aqueous buffer solution. The fluid dispensed by the metered fluid dosing element 140 may be an aqueous fluid having a surfactant. The fluid dispensed by the metered fluid dosing element 140 may be saline. The fluid dispensed by the metered fluid dosing element 140 may be saline containing a surfactant. The fluid dispensed by the metered fluid dosing element 140 may be saline containing 0.5% to 2% surfactant by weight.

[0067] The sample collection device 100 may further include a fluid flow channel configured to direct fluid from the fluid inlet port 130 to the porous sample collection medium 120. The fluid flow channel can deliver fluid to the porous sample collection medium 120 via capillary action.

[0068] The sample collection device 100 may include a fluid collection receptacle 150 disposed within the housing 110 and configured to receive fluid from the porous sample collection medium 120. The sample collection device 100 may further include a second fluid flow channel configured to direct fluid from the porous sample collection medium 120. The fluid flow channel may deliver fluid via capillary action.

[0069] In some embodiments, the sample collection device 100 may include two, three, four, or five or more fluid inlet ports 130. Each fluid inlet port 130 may independently include a metered fluid dosage element 140 movably attached to the corresponding fluid inlet port 130. The two or more metered fluid dosage elements 140 may each include the same fluid material. Alternatively, at least one of the two or more metered fluid dosage elements 140 may include a fluid material that is different from the fluid material included in another metered fluid dosage element 140. For example, the independently selected fluid for each metered fluid dosage element 140 may be selected to interact, react, activate, or deactivate with another independently selected fluid in another metered fluid dosage element 140.

[0070] The present disclosure is also directed to a sample collection system 200. The sample collection system 200 includes the sample collection device 100 described above and an assay 210 configured to receive fluid from a fluid collection receptacle 150. As described above, the assay 210 may be integral with the sample collection device 100 forming a unitary body, or the assay 210 may be a replaceable element that is received and removed from the housing 110.

[0071] The housing 110 may include an opening configured to receive the assay 210. The opening 117 of the housing 110 may mate with the assay 210 to receive at least a portion of the assay within the opening of the housing 110. In one embodiment, the opening of the housing 110 may receive the entire assay 210 within the housing.

[0072] The assay 210 may include a sample inlet 220. The sample inlet 220 may be aligned with the fluid collection receptacle 150. Fluid from the porous sample collection medium 120 may flow into the fluid collection receptacle 150 and into the sample inlet 220 of the assay 210.

[0073] The assay 210 may be a flow assay, such as a lateral flow assay or a vertical flow assay. The assay 210 may detect a virus or pathogen. The assay 210 may include a test result display window to indicate the presence or absence of the virus or pathogen.

[0074] The assays may be referred to as lateral flow assays (LFA) or vertical flow assays (VFA), which are generally paper-based platforms for the detection and quantification of analytes in complex mixtures, where a sample is placed on the test device and the results are displayed within 5-30 minutes. The low development costs and ease of manufacture of LFAs have led to the expansion of their application to multiple areas where rapid testing is required. LFA-based tests are widely used in hospitals, clinics, and clinical laboratories for the qualitative and quantitative detection of specific antigens and antibodies, as well as products of gene amplification. A variety of biological samples can be tested using the assays.

[0075] 1 shows that the porous sample collection medium 120 may be adjacent to the sample inlet 220 of the assay 210. The porous sample collection medium 120 may direct fluid directly into the sample inlet 220. In some embodiments, the porous sample collection medium 120 may be in contact with the sample inlet 220. The porous sample collection medium 120 may direct fluid directly into the sample inlet 220.

[0076] Figure 4 is a rear perspective schematic view of another exemplary sample collection device 300. Figure 5 is a side schematic view of the sample collection device 300 of Figure 4. Figure 6 is a front schematic view of the sample collection device 300 of Figure 4. Figure 7 is a cross-sectional schematic view of the sample collection device 300 of Figure 5. These figures show the metered fluid dosage element 140 disassembled from the fluid inlet port 130 for clarity.

[0077] In this embodiment, air flows through both the porous sample collection medium 120 and the bypass vents shown in Figure 6 that surround the porous sample collection medium 120. The ratio of the area of ​​the bypass vents to the area of ​​the porous sample collection medium 120 may be varied to obtain adequate airflow through the sample collection device 300 with adequate virus capture on the porous sample collection medium 120.

[0078] The sample collection device 300 includes a housing 110 extending from a mouthpiece portion 112 to an air outlet portion 114. The housing 110 defines an airflow channel 116 from the mouthpiece portion 112 to the air outlet portion 114. The mouthpiece portion 112 is configured to receive an exhaled airflow 115. A porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. A fluid inlet port 130 defines an opening through the housing 110 and is adjacent to the porous sample collection medium 120. The fluid inlet port 130 is configured to direct a fluid onto the porous sample collection medium 120. A metered fluid dosage element 140 is attached to the fluid inlet port 130. The metered fluid dosage element 140 is configured to dispense a metered volume of fluid into the fluid inlet port 130.

[0079] The housing 110 may be formed from a rigid material such as plastic. The airflow channel 116 may extend from an opening in the mouthpiece portion 112 to an air outlet portion 114 having one or more air outlets. A user exhales into the opening in the mouthpiece portion 112, and the exhaled airflow exits the sample collection device 300 through one or more air outlets in the air outlet portion 114. The airflow channel 116 may extend longitudinally along a longitudinal axis of the housing 110. Alternatively, the airflow channel 116 may extend coaxially along a central longitudinal axis of the housing 110.

[0080] A porous sample collection medium 120 is secured within the housing 110 along the airflow channel 116. The exhaled airflow 115 passes through the thickness of the porous sample collection medium 120. The porous sample collection medium 120 at least partially occludes the airflow channel 116. The porous sample collection medium 120 may occlude the airflow channel 116. The porous sample collection medium 120 is shown as having a major plane that is orthogonal to the direction of the exhaled airflow 115 passing through the thickness of the porous sample collection medium 120.

[0081] In other embodiments, the porous sample collection medium 120 may have a major plane that forms an angle with the direction of the incoming exhaled airflow 115 through the thickness of the porous sample collection medium 120. This angle may be in the range of about 91 degrees to about 179 degrees, or in the range of about 100 degrees to about 160 degrees, or in the range of about 115 degrees to about 150 degrees, or in the range of about 125 degrees to about 145 degrees.

[0082] The porous sample collection medium 120 may be a nonwoven material configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a nonwoven material having an electrostatic charge configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a hydrophobic nonwoven material configured to filter pathogens or viruses from the exhaled airstream 115. The porous sample collection medium 120 may be a hydrophobic nonwoven material having an electrostatic charge configured to filter pathogens or viruses from the exhaled airstream 115.

[0083] The porous sample collection medium 120 may be formed from any of the materials described herein. The porous sample collection medium 120 may be secured directly to the housing 110. FIG. 7 shows a support element 125 in contact with and supporting the porous sample collection medium 120. The support element 125 includes one or more openings configured to allow the exhaled airflow to pass through the support element 125. The support element 125 may be secured to the housing 110 and disposed within the airflow channel 116. The porous sample collection medium 120 may be secured directly to the support element 125.

[0084] The metered fluid dosage element 140 may be movably mounted to the fluid inlet port 130 between at least a first fluid-loading position and a second fluid-depleting position, the second fluid-depleting position being closer to the housing than the first fluid-loading position. In the first fluid-loading position, the metered fluid dosage element 140 contains a metered volume of fluid, and in the second fluid-depleting position, the metered fluid dosage element 140 delivers a metered volume of fluid into the fluid inlet 130 and onto the porous sample collection medium 120.

[0085] The metered fluid dosage element 140 may include a fluid reservoir 142. The metered fluid dosage element 140 may define a volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. The metered fluid dosage element 140 may include a plunger element 145 that moves into the volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. The plunger element 145 may include an opening 141 for releasing fluid from the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. A sealing element may be disposed over the opening 141 to seal the fluid in the fluid reservoir 142. The seal may be broken by the pressure of the fluid as the metered fluid dosage element 140 moves to the second, fluid-depleted position. One exemplary metered fluid dosage element 140 is commercially available under the trade name CUROS from 3M Company, St. Paul MN, USA. Figure 7 shows a cross-sectional view of a metered fluid dosage element 140. The metered fluid dosage element 140 shown in Figures 1-6 and 8-9 includes those elements shown herein in cross-section in Figure 7.

[0086] The fluid inlet port 130 can define a projection 132 extending away from the exterior surface of the housing 110. The metered fluid dosage element 140 can define a cap movably attached to the projection 132 between at least a first fluid-loaded position and a second fluid-depleted position.

[0087] The porous sample collection medium 120 defines a major surface area value and the fluid reservoir 142 defines a volume value, where the volume value divided by the surface area value is 10 microliters / cm. 2 ~400 microliters / cm 2 , or 10 microliters / cm 2 ~250 microliters / cm 2 , or 50 microliters / cm 2 ~150 microliters / cm2 In some embodiments, the fluid reservoir 142 defines a volume in the range of 50 microliters to 500 microliters.

[0088] The metered fluid dosage element 140 may be movably attached to the fluid inlet port 130 via the threaded connection 134. Thus, the metered fluid dosage element 140 may be moved between a first, fluid-loaded position and a second, fluid-depleted position by rotating the metered fluid dosage element 140 about the threaded axis.

[0089] The fluid dispensed by the metered fluid dosage element 140 may be any fluid described herein.

[0090] The sample collection device 300 may further include a fluid flow channel configured to direct fluid from the fluid inlet port 130 to the porous sample collection medium 120. The fluid flow channel can deliver fluid to the porous sample collection medium 120 via capillary action.

[0091] The sample collection device 300 may include a fluid collection receptacle 150 disposed within the housing 110 and configured to receive fluid from the porous sample collection medium 120. The sample collection device 300 may further include a second fluid flow channel 119 configured to direct fluid from the porous sample collection medium 120. The second fluid flow channel 119 may deliver fluid via capillary action. The fluid collection receptacle 150 may include a fluid outlet 152 configured to direct fluid out of the sample collection device 300.

[0092] The sample collection device 300 may include a pre-filter element 160 secured within the housing 110 along the airflow channel 116. The pre-filter element 160 may be disposed along the airflow channel 116 between the mouthpiece element 112 and the porous sample collection medium 120. The pre-filter element 160 may be disposed along the airflow channel 116 between the mouthpiece element 112 and the fluid inlet port 130. The exhaled airflow 115 passes through a thickness of the pre-filter element 160. The pre-filter element 160 at least partially occludes the airflow channel 116. The pre-filter element 160 may occlude the airflow channel 116.

[0093] The prefilter element 160 is shown as having a major plane perpendicular to the direction of the exhaled airflow 115 through the thickness of the prefilter element 160. The prefilter element 160 may be a nonwoven layer configured to filter out larger particles from the exhaled airflow 115 passing through the prefilter element 160. The prefilter element 160 may be a nonwoven layer that does not have an electrostatic charge. The prefilter element 160 is configured not to trap viruses or pathogens. The prefilter element 160 is configured to allow viruses or pathogens to pass through the prefilter element 160. The prefilter element 160 may be incorporated into any of the embodiments shown herein.

[0094] In some embodiments, the sample collection device 300 may include two, three, four, or five or more fluid inlet ports 130. Each fluid inlet port 130 may independently include a metered fluid dosage element 140 movably attached to the corresponding fluid inlet port 130. The two or more metered fluid dosage elements 140 may each include the same fluid material. Alternatively, at least one of the two or more metered fluid dosage elements 140 may include a fluid material that is different from a fluid material included in another metered fluid dosage element 140. As described above, the different fluids may be selected to interact or react with each other upon deployment of each fluid into the sample collection device 300.

[0095] The present disclosure is also directed to a sample collection system, as described above, that includes a sample collection device 300 and an assay configured to receive fluid from a fluid collection receptacle 150 via a fluid outlet 152.

[0096] Figure 8 is a rear perspective schematic view of another exemplary sample collection device 400. Figure 9 is a side schematic view of the sample collection device 400 of Figure 8. Figure 10 is a cross-sectional schematic view of the sample collection device 400 of Figure 9. These figures show the metered fluid dosage element 140 disassembled from the fluid inlet port 130 for clarity.

[0097] The sample collection device 400 includes a housing 110 extending from a mouthpiece portion 112 to an air outlet portion 114. The housing 110 defines an airflow channel 116 from the mouthpiece portion 112 to the air outlet portion 114. The mouthpiece portion 112 is configured to receive an exhaled airflow 115. A porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. A fluid inlet port 130 defines an opening through the housing 110 and is adjacent to the porous sample collection medium 120. The fluid inlet port 130 is configured to direct a fluid onto the porous sample collection medium 120. A metered fluid dosage element 140 is movably attached to the fluid inlet port 130. The metered fluid dosage element 140 is configured to dispense a metered volume of fluid into the fluid inlet port 130.

[0098] The housing 110 may be formed from a rigid material such as plastic. The airflow channel 116 may extend from an opening in the mouthpiece portion 112 to an air outlet portion 114 having one or more air outlets. A user exhales into the opening in the mouthpiece portion 112, and the exhaled airflow exits the sample collection device 400 through one or more air outlets in the air outlet portion 114. The airflow channel 116 may extend longitudinally along at least a portion of a longitudinal axis of the housing 110. The airflow channel 116 may extend coaxially along at least a portion of a central longitudinal axis of the housing 110.

[0099] The porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. The exhaled airflow 115 passes through a thickness of the porous sample collection medium 120. The porous sample collection medium 120 at least partially occludes the airflow channel 116. The porous sample collection medium 120 may occlude the airflow channel 116. The porous sample collection medium 120 may have a major plane that is orthogonal to the direction of the exhaled airflow 115 passing through the thickness of the porous sample collection medium 120.

[0100] The porous sample collection medium 120 is shown as having a major plane that forms an angle with the direction of the incoming exhaled airflow 115 through the thickness of the porous sample collection medium 120. This angle may be in the range of about 91 degrees to about 179 degrees, or in the range of about 100 degrees to about 160 degrees, or in the range of about 115 degrees to about 150 degrees, or in the range of about 125 degrees to about 145 degrees.

[0101] The porous sample collection medium 120 may be formed from any of the materials described above.

[0102] The porous sample collection medium 120 may be secured directly to the housing 110. FIG. 10 shows a support element 125 in contact with and supporting the porous sample collection medium 120. The support element 125 includes one or more openings configured to allow the exhaled airflow to pass through the support element 125. The support element 125 may be secured to the housing 110 and disposed within the airflow channel 116. The porous sample collection medium 120 may be secured directly to the support element 125.

[0103] The baffle 111 may be secured directly to the housing 110. The baffle 111 may be secured to the housing 110 and disposed within the airflow channel 116. The baffle 111 may be configured to direct fluid away from the mouthpiece portion 112. The baffle 111 may also be configured to knock larger particles out of the exhaled airflow and prevent or reduce particles larger than a virus or pathogen from reaching the porous sample collection medium 120. The baffle 111 includes one or more protruding elements configured to create a tortuous airflow path to knock larger particles out of the exhaled airflow and prevent or reduce particles larger than a virus or pathogen from reaching the porous sample collection medium 120.

[0104] The metered fluid dosage element 140 may be movably mounted to the fluid inlet port 130 between a first fluid-loading position and a second fluid-depleting position, the second fluid-depleting position being closer to the housing than the first fluid-loading position. In the first fluid-loading position, the metered fluid dosage element 140 contains a metered volume of fluid, and in the second fluid-depleting position, the metered fluid dosage element 140 delivers a metered volume of fluid into the fluid inlet 130 and onto the porous sample collection medium 120.

[0105] The metered fluid dosage element 140 may include a fluid reservoir 142. The metered fluid dosage element 140 may define a volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. The metered fluid dosage element 140 may include a plunger element 145 that moves into the volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. The plunger element 145 may include an opening 141 for releasing fluid from the fluid reservoir 142 when the metered fluid dosage element 140 moves from the first fluid-loaded position to the second fluid-depleted position. The sealing element can cover the opening 141 and seal the fluid in the fluid reservoir 142 until pressure or force ruptures the seal and releases the fluid into the fluid inlet port 130. One exemplary metered fluid dosage element 140 is commercially available under the trade name CUROS from 3M Company, St. Paul MN, USA. One exemplary metered fluid dosage element 140 is commercially available under the trade name CUROS from 3M Company, St. Paul MN, USA. Figure 10 shows a cross-sectional view of a metered fluid dosage element 140. The metered fluid dosage element 140 shown in Figures 1-6 and 8-9 includes those elements shown herein in cross-section in Figure 7.

[0106] The fluid inlet port 130 can define a protrusion 132 extending away from the exterior surface of the housing 110. The metered fluid dosage element 140 can define a cap movably mounted on the protrusion 132 between a first, fluid-loaded position and a second, fluid-depleted position.

[0107] The porous sample collection medium 120 defines a major surface area value and the fluid reservoir 142 defines a volume value, where the volume value divided by the surface area value is 10 microliters / cm. 2 ~400 microliters / cm 2 , or 10 microliters / cm 2 ~250 microliters / cm 2, or 50 microliters / cm 2 ~150 microliters / cm 2 In some embodiments, the fluid reservoir 142 defines a volume in the range of 50 microliters to 500 microliters.

[0108] The metered fluid dosage element 140 may be movably attached to the fluid inlet port 130 via the threaded connection 134. Thus, the metered fluid dosage element 140 may be moved between a first, fluid-loaded position and a second, fluid-depleted position by rotating the metered fluid dosage element 140 about the threaded axis.

[0109] The fluid dispensed by the metered fluid dosage element 140 may be any fluid described herein.

[0110] The sample collection device 300 may further include a fluid flow channel 118 configured to direct fluid from the fluid inlet port 130 to the porous sample collection medium 120. The fluid flow channel 118 can deliver fluid to the porous sample collection medium 120 via capillary action.

[0111] The sample collection device 400 may include a fluid collection receptacle 150 disposed within the housing 110 and configured to receive fluid from the porous sample collection medium 120. The sample collection device 400 may further include a second fluid flow channel 119 configured to direct fluid from the porous sample collection medium 120. The second fluid flow channel 119 may deliver fluid via capillary action. The fluid collection receptacle 150 may include a fluid outlet 152 configured to direct fluid out of the sample collection device 400.

[0112] In some embodiments, the sample collection device 400 may include two, three, four, five, or more fluid inlet ports 130. Each fluid inlet port 130 may independently include a metered fluid dosage element 140 attached to the corresponding fluid inlet port 130. The two or more metered fluid dosage elements 140 may each include the same fluid material. Alternatively, at least one of the two or more metered fluid dosage elements 140 may include a fluid material that is different from a fluid material included in another metered fluid dosage element 140. As described above, the different fluids may be selected to interact or react with each other upon deployment of each fluid into the sample collection device 400.

[0113] The present disclosure is also directed to a sample collection system that includes the sample collection device 400 described above and an assay configured to receive fluid from the fluid collection receptacle 150 via the fluid outlet 152, as described above.

[0114]

[0115] FIG 11 is a rear perspective schematic view of another exemplary sample collection device 500 having a removable mouthpiece. FIG 12 is a side schematic view of the sample collection device 500 of FIG 11. FIG 13 is a cross-sectional schematic view of the sample collection device 500 of FIG 12. FIG 14 is a rear perspective schematic view of another exemplary sample collection device 500 having a removable fluid collection receptacle. FIG 15 is a side schematic view of the sample collection device 500 of FIG 14. FIG 16 is a cross-sectional schematic view of the sample collection device 500 of FIG 15.

[0116] 11-15 show the same sample collection device 500, without the replaceable mouthpiece portion 112 and fluid collection receptacle 150. A user exhales into the mouthpiece portion 112 of the sample collection device 500 and then replaces the mouthpiece portion 112 with the fluid collection receptacle 150, releasing the fluid for collection by the fluid collection receptacle 150 and subsequent testing, as described above.

[0117] The sample collection device 500 includes a housing 110 extending from a mouthpiece portion 112 to an air outlet portion 114. The housing 110 defines an airflow channel 116 from the mouthpiece portion 112 to the air outlet portion 114. The mouthpiece portion 112 is configured to receive an exhaled airflow 115. A porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. A fluid inlet port 130 defines an opening through the housing 110 and is adjacent to the porous sample collection medium 120. The fluid inlet port 130 is configured to direct a fluid onto the porous sample collection medium 120. A metered fluid dosage element 140 is movably attached to the fluid inlet port 130. The metered fluid dosage element 140 is configured to dispense a metered volume of fluid into the fluid inlet port 130.

[0118] The housing 110 may be formed from a rigid material such as plastic. The airflow channel 116 may extend from an opening in the mouthpiece portion 112 to an air outlet portion 114 having one or more air outlets. A user exhales into the opening in the mouthpiece portion 112, and the exhaled airflow exits the sample collection device 500 through one or more air outlets in the air outlet portion 114. The airflow channel 116 may extend longitudinally along a longitudinal axis of the housing 110. The airflow channel 116 may extend coaxially along a central longitudinal axis of the housing 110.

[0119] The porous sample collection medium 120 is disposed within the housing 110 along the airflow channel 116. The exhaled airflow 115 passes through a thickness of the porous sample collection medium 120. The porous sample collection medium 120 at least partially occludes the airflow channel 116. The porous sample collection medium 120 may occlude the airflow channel 116. The porous sample collection medium 120 may have a major plane that is orthogonal to the direction of the exhaled airflow 115 passing through the thickness of the porous sample collection medium 120.

[0120] The porous sample collection medium 120 is shown as having a major plane that forms an angle with the direction of the incoming exhaled airflow 115 through the thickness of the porous sample collection medium 120. This angle may be in the range of about 91 degrees to about 179 degrees, or in the range of about 100 degrees to about 160 degrees, or in the range of about 115 degrees to about 150 degrees, or in the range of about 125 degrees to about 145 degrees.

[0121] The porous sample collection medium 120 may be formed from any of the materials described herein.

[0122] The porous sample collection medium 120 may be secured directly to the housing 110. Figures 13 and 16 show a support element 125 in contact with and supporting the porous sample collection medium 120. The support element 125 includes one or more openings configured to allow the exhaled airflow to pass through the support element 125. The support element 125 may be secured to the housing 110 and disposed within the airflow channel 116. The porous sample collection medium 120 may be secured directly to the support element 125.

[0123] The metered fluid dosage element 140 may include a plunger element 145 movably mounted to the fluid inlet port 130 between a first fluid-loading position and a second fluid-depleting position, the second fluid-depleting position being closer to the housing than the first fluid-loading position. In the first fluid-loading position, the metered fluid dosage element 140 contains a metered volume of fluid, and in the second fluid-depleting position, the metered fluid dosage element 140 delivers a metered volume of fluid into the fluid inlet 130 and onto the porous sample collection medium 120.

[0124] The metered fluid dosage element 140 can include a fluid reservoir 142. The metered fluid dosage element 140 can define a volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from a first fluid-loaded position to a second fluid-depleted position. The metered fluid dosage element 140 may include a plunger element 145 that moves into the volume configured to hold the fluid reservoir 142 and release the fluid reservoir 142 when the metered fluid dosage element 140 moves from a first fluid-loaded position to a second fluid-depleted position. Figures 13 and 16 show cross-sectional views of the metered fluid dosage element 140. The fluid reservoir 142 can include a first seal 143 and a second seal 146 for containing fluid within the fluid reservoir 142. The plunger 145 penetrates the first seal 143 and forms an opening 141 in the second seal 146 to allow release of fluid into the fluid inlet port 130 .

[0125] The fluid inlet port 130 can define a projection 132 extending away from the exterior surface of the housing 110. The metered fluid dosage element 140 can include a plunger element 145 movably mounted on the projection 132 between at least a first, fluid-loaded position and a second, fluid-depleted position.

[0126] The porous sample collection medium 120 defines a major surface area value and the fluid reservoir 142 defines a volume value, where the volume value divided by the surface area value is 10 microliters / cm. 2 ~400 microliters / cm 2 , or 10 microliters / cm 2 ~250 microliters / cm 2 , or 50 microliters / cm 2 ~150 microliters / cm 2 In some embodiments, the fluid reservoir 142 defines a volume in the range of 50 microliters to 500 microliters.

[0127] The fluid dispensed by the metered fluid dosage element 140 may be any fluid described herein.

[0128] The sample collection device 500 may include a pre-filter element 160 secured within the mouthpiece 112 along the airflow channel 116. Alternatively, the pre-filter element 160 may be disposed along the airflow channel 116 between the mouthpiece element 112 and the porous sample collection medium 120. The exhaled airflow 115 passes through a thickness of the pre-filter element 160. The pre-filter element 160 at least partially occludes the airflow channel 116. The pre-filter element 160 may occlude the airflow channel 116.

[0129] The prefilter element 160 is shown as having a major plane perpendicular to the direction of the exhaled airflow 115 through the thickness of the prefilter element 160. The prefilter element 160 may be a nonwoven layer configured to filter out larger particles from the exhaled airflow 115 passing through the prefilter element 160. The prefilter element 160 may be a nonwoven layer that does not have an electrostatic charge. The prefilter element 160 is configured not to trap viruses or pathogens. The prefilter element 160 is configured to allow viruses or pathogens to pass through the prefilter element 160. The prefilter element 160 may be incorporated into any of the embodiments shown herein.

[0130] The sample collection device 500 may further include a fluid flow channel configured to direct fluid from the fluid inlet port 130 to the porous sample collection medium 120. The fluid flow channel can deliver fluid to the porous sample collection medium 120 via capillary action.

[0131] The sample collection device 500 may include a fluid collection receptacle 150 disposed within the body 110 and configured to receive fluid from the porous sample collection medium 120. The sample collection device 500 may further include a second fluid flow channel configured to direct fluid from the porous sample collection medium 120. The second fluid flow channel may deliver fluid via capillary action. The fluid collection receptacle 150 may include a fluid outlet 152 configured to direct fluid out of the sample collection device 500.

[0132] In some embodiments, the sample collection device 500 may include two, three, four, five, or more fluid inlet ports 130. Each fluid inlet port 130 may independently include a metered fluid dosage element 140 movably attached to the corresponding fluid inlet port 130. The two or more metered fluid dosage elements 140 may each include the same fluid material. Alternatively, at least one of the two or more metered fluid dosage elements 140 may include a fluid material that is different from a fluid material included in another metered fluid dosage element 140. As described above, the different fluids may be selected to interact or react with each other upon deployment of each fluid into the sample collection device 500.

[0133] The present disclosure is also directed to a sample collection system that includes the sample collection device 500 described above and an assay configured to receive fluid from the fluid collection receptacle 150 via the fluid outlet 152.

[0134] 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. 1. A sample collection device comprising: a housing extending from an exhaled air receiving portion to an air outlet portion, the housing defining an airflow channel from the exhaled air receiving portion to the air outlet portion, the exhaled air receiving portion configured to receive the exhaled airflow; a porous sample collection medium disposed within the housing along the airflow channel; a fluid inlet port defining an opening through the housing adjacent the porous sample collection medium, the fluid inlet port configured to direct a fluid onto the porous sample collection medium; a metered fluid dosage element attached to the fluid inlet port, the metered fluid dosage element configured to dispense a metered volume of fluid into the fluid inlet port.

2. A sample collection device according to claim 1; an assay configured to receive fluid from the sample collection device; A sample collection system comprising:

3. flowing exhaled air through a porous sample collection medium, the porous sample collection medium being disposed within an airflow channel forming a loaded porous sample collection medium; flowing a metered volume of fluid through the loaded porous sample collection medium disposed within the airflow channel to form an eluate; collecting the eluate; A method comprising:

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