Sample collection devices and systems

Abstract

The sample collection device includes a housing extending from a mouthpiece end to an air outlet end, the housing defining an airflow channel from the mouthpiece end to the air outlet end, the mouthpiece end configured to receive the exhaled airflow, a porous sample collection medium disposed within the housing along the airflow channel, a mouthpiece end cap replaceably coupled to the mouthpiece end, and an air outlet end cap replaceably coupled to the air outlet end.

Description

[Background technology]

[0001] The present disclosure relates to sample collection devices and systems, methods for using the sample collection devices and systems, and sample collection kits.

[0002] As Covid-19 reached pandemic status, it was important that diagnostic testing availability be increased to help identify and control severe disease. The disease highlighted the need for such diagnostic testing to be widely available even after the pandemic has ended. 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 at-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 purification steps when using RT-PCR molecular tests. Summary of the Invention

[0003] The above sample collection devices and testing processes have various challenges. For example, these available tests typically require the collection device to be processed in a laboratory, increasing costs and delaying the delivery of results. Furthermore, many of the testing methods require the sample collection mechanism to be a nasopharyngeal swab or other type of nose or mouth swab, which is uncomfortable for the user. This discomfort may cause users to not take the test. Furthermore, the sample may become contaminated during transfer to a clean container, removal from the container, etc. Because multiple steps and devices are involved and the sample may become contaminated, such conventional methods and devices for sample collection and eluent testing may only be used by trained professionals (e.g., medical personnel) and may be complicated for use by users with little or no training.

[0004] In some embodiments, the present disclosure provides an easy-to-use, inexpensive integrated sample collection and testing device in which sample collection and sample testing occur in a single integrated device that can be used by the public in any location. Other embodiments of the present disclosure provide a sample collection device that does not require the user to receive a nasopharyngeal swab or other nasal or oral swab. In some embodiments, the integrated sample collection and testing device and / or the sample collection device collects only bioaerosols. The bioaerosols can be, for example, from nasal or oral exhalation.

[0005] In some embodiments, the integrated sample collection and testing device and / or the sample collection device collects exhaled breath from the nose and / or the mouth, In some embodiments, the integrated sample collection and testing device and / or the sample collection device collects exhaled breath from the nose.

[0006] There is also a need for inexpensive, easy to use, and reliable sample collection devices that can be used by members of the public and / or medical professionals around the world to test for the presence or absence of pathogens or viruses. These sample collection devices may be combined with testing devices to determine the presence or absence of pathogens or viruses in the collected sample.

[0007] Some aspects of the disclosure describe a sample collection device that includes a housing extending from a mouthpiece end to an air outlet end, the housing defining an airflow channel from a breath receiving portion or mouthpiece end to the air outlet end, the breath receiving portion or mouthpiece end configured to receive the exhaled airflow. A porous sample collection medium is secured within the housing along the airflow channel. A breath receiving portion or mouthpiece end cap is replaceably coupled to the breath receiving portion or mouthpiece end, and an air outlet end cap is replaceably coupled to the air outlet end.

[0008] The sample collection device may be combined with instructions for collecting a sample to form a kit. The instructions may instruct a user to blow into an airflow channel of the housing to capture a sample in the porous sample collection medium, replaceably couple an air outlet end cap to the air outlet end to seal the air outlet end, flow liquid through the porous sample collection medium, and couple a breath receiving portion or mouthpiece end cap to the breath receiving portion or mouthpiece end to seal the breath receiving portion or mouthpiece end. The sealed sample collection device may be transported to a testing site that is remote in time or location relative to the time and location at which the sample was collected.

[0009] In some embodiments, it may be desirable to provide a system that includes both a sample collection device and a rapid test device. This system may advantageously be self-contained and sterile (unlike swabs, which can become contaminated during use, pose biohazard risks during processing, and provide opportunities for cross-contamination between samples). This system may also advantageously produce cleaner samples for testing that are free of inhibitors, providing more accurate and reliable results.

[0010] A method of collecting a sample may include flowing breath into a sample collection device to cause liquid to flow through a loaded sample collection medium to form an eluent, and sealing the breath receiving portion or mouthpiece end with a breath receiving portion or mouthpiece end cap.

[0011] The eluent may be forced through a nozzle or liquid nozzle defining a dropper or liquid dropper secured to the breath-receiving portion or mouthpiece end cap or the breath-receiving portion or mouthpiece end, and the expelled eluent may be tested using an assay such as a vertical assay or a lateral assay. [Brief description of the drawings]

[0012] [Figure 1] 1 is a side schematic view of an exemplary sample collection device collecting a sample. [Diagram 2] 1 is a schematic side view of an exemplary sample collection device having liquid flowing through a porous sample collection medium. [Diagram 3] FIG. 2 is a schematic side view of an exemplary sample collection device flowing liquid from a porous sample collection medium onto an assay.

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

[0014] The term "substantially" as used herein has the same meaning as "significantly" and can be understood 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 has the same meaning as "not significantly" and can be understood to have the opposite meaning of "substantially", i.e., modifying the following term by 10% or less, 5% or less, or 2% or less.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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 air outlet end. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] FIELD OF THE DISCLOSURE The present disclosure relates to sample collection devices, kits, systems, and methods. In some embodiments, the present disclosure relates to bioaerosol collection devices, kits, systems, and methods.

[0025] In some embodiments, the sample collection device includes a housing extending from a mouthpiece end to an air outlet end, the housing defining an airflow channel from the mouthpiece end to the air outlet end, the mouthpiece end configured to receive the exhaled airflow. A porous sample collection medium is secured within the housing along the airflow channel. A mouthpiece end cap is replaceably coupled to the mouthpiece end, and an air outlet end cap is replaceably coupled to the air outlet end.

[0026] The mouthpiece or breath receiving portion is configured to receive the breath airflow from one or more of the mouth or nose. For example, the mouthpiece or breath receiving portion can be breathed into by contact with or adjacent to the mouth, or by contact with the nose / nostrils, or by contacting each individually or collectively. The breath airflow received by the mouthpiece or breath receiving portion can be either or both of mouth exhalation or nasal exhalation. As used herein, the term "mouthpiece" is intended to refer to a breath receiving portion that can receive mouth exhalation or nasal exhalation of an aerosol or bioaerosol.

[0027] Although the porous sample collection medium is shown herein as defining a planar element, it is understood that the porous sample collection medium can define any shape when disposed within the housing and along the airflow channel. For example, 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.

[0028] The sample collection device includes a porous sample collection medium disposed within a device housing and along an airflow channel defined by the device housing. Once a sample has been collected on the porous sample collection medium, an open end of the housing may be sealed for testing at a future time and / or at a location remote from the sample collection site. After one or both open ends of the housing may be sealed, liquid may be passed through the porous sample collection medium.

[0029] One of the open ends of the housing may be closed or sealed with an end cap containing a nozzle or liquid dropper. The nozzle or liquid dropper may further include a nozzle cap or dropper cap to seal the end of the nozzle or liquid dropper to maintain the liquid within the housing for testing at a future time and / or at a location remote from the sample collection site. The nozzle or liquid dropper provides a convenient method for depositing a droplet from the housing onto the assay. Preferably, a portion of the housing or one or both of the end caps may be "squeezable" to force liquid out of the sample collection device through the nozzle or liquid dropper.

[0030] Figure 1 is a side schematic view of a sample collection device 100 collecting a sample. Figure 2 is a side schematic view of an exemplary sample collection device 100 flowing a liquid 170 through a porous sample collection medium 150. Figure 3 is a side schematic view of an exemplary sample collection device 100 flowing a liquid 170 from the porous sample collection medium 150 onto an assay 180.

[0031] The sample collection device 100 includes a housing 110 extending from a mouthpiece end 112 to an air outlet end 114, the housing 110 defining an airflow channel 116 from the mouthpiece end 112 to the air outlet end 114, the mouthpiece end 112 being configured to receive an exhaled airflow 160 (e.g., from the nose or mouth or both). A porous sample collection medium 150 is secured within the housing 110 along the airflow channel 116. A mouthpiece end cap 120 is replaceably coupled to the mouthpiece end 112, and an air outlet end cap 125 is replaceably coupled to the air outlet end 114.

[0032] The housing 110 may define an open cylindrical airflow channel 116 extending a length L along the longitudinal axis from the mouthpiece end 112 to the air outlet end 114. The open cylindrical airflow channel 116 may have a uniform diameter along the length L from the mouthpiece end 112 to the air outlet end 114. The open cylindrical airflow channel 116 may have a decreasing diameter along the length L, tapering from the mouthpiece end 112 to the air outlet end 114. The open cylindrical airflow channel 116 may have an increasing diameter along the length L, tapering from the air outlet end 114 to the mouthpiece end 112.

[0033] The housing 110 is formed from a liquid and fluid impermeable material. The housing 110 may be formed from a liquid and fluid impermeable material that can be deformed or plastically deformed by pressure of a user's fingers, similar to a squeeze bottle, to force liquid out of the housing 110. The housing 110 may be formed from a polymer. The housing may have a uniform thickness, for example in the range of 0.5 mm to 2 mm. Advantageously, a user can squeeze or compress the housing 110 at the porous sample collection medium 150 to "squeeze" liquid out of the porous sample collection medium 150.

[0034] The mouthpiece end cap 120 and the air outlet end cap 125 may be formed of the same type of material or different types of materials. The mouthpiece end cap 120 and / or the air outlet end cap 125 may be formed of the same type of material as the housing 110. One or both of the mouthpiece end cap 120 and the air outlet end cap 125 may be squeezable, similar to a squeeze bottle, or may deform or plastically deform under the pressure of a user's fingers to force liquid out of the housing 110 (when both the mouthpiece end cap 120 and the air outlet end cap 125 are attached to the housing 110). The mouthpiece end cap 120 and the air outlet end cap 125 may be formed of a polymer.

[0035] Mouthpiece end cap 120 and air outlet end cap 125 may be separate from housing 110. Mouthpiece end cap 120 may be coupled to housing 110, for example, via tether 122. Air outlet end cap 125 may be coupled to housing 110, for example, via tether 127. Tether 122 may be connected to any portion of mouthpiece end cap 120. Tether 122 may be connected to any portion of housing 110. Tether 127 may be connected to any portion of air outlet end cap 125. Tether 127 may be connected to any portion of housing 110.

[0036] One of the mouthpiece end cap 120 and the air outlet end cap 125 may further include a nozzle or liquid dropper 124. The nozzle or liquid dropper 124 may allow or be configured to allow liquid to exit the housing 110 in a droplet manner, similar to an eye dropper. The nozzle or liquid dropper 124 may further include a nozzle or liquid dropper cap configured to close or seal the nozzle or liquid dropper 124, similar to an eye dropper cap. The nozzle or liquid dropper cap may be replaceably attached to the nozzle or liquid dropper 124 to preserve liquid within the sample collection device 100 for subsequent testing.

[0037] A liquid reservoir may be fluidly coupled to the sample collection device 100 and configured to provide a measured amount of liquid onto the porous sample collection medium 150 secured within the housing 110. The measured amount of liquid passes through the porous sample collection medium 150, carrying away any pathogens or viruses that may be bound to the porous sample collection medium 150. The measured amount of liquid 170 may then be analyzed.

[0038] The liquid reservoir may be secured to the housing 110 and provide liquid flow through a sidewall of the housing 110. The liquid reservoir may be secured to the mouthpiece end cap 120 and provide liquid flow through a wall of the mouthpiece end cap 120. The liquid reservoir may be secured to the air outlet end cap 125 and provide liquid flow through a wall of the air outlet end cap 125.

[0039] Alternatively, a user may apply liquid, for example in a dropwise manner, to one open end of the housing 110, thereby causing a measured amount of liquid to flow onto the porous sample collection medium 150 secured within the housing 110. In one example, a user may blow through the open-ended housing 110, then seal the air outlet end 114 with the air outlet end cap 125, then add a measured amount of liquid 170 into the housing 110 via the open mouthpiece end 112, which causes the measured amount of liquid 170 to flow through the porous sample collection medium 150, stripping any biological material on the porous sample collection medium 150, and then the user may seal the mouth end 112 with the mouth end cap 120. The user may then squeeze the sample collection device 100 to force the liquid out of the housing 110, such as through the nozzle or liquid dropper 124, onto the assay 180 in a dropwise manner.

[0040] The metered amount of liquid 170 may be an aqueous liquid. The metered amount of liquid 170 may be an aqueous buffer solution. The metered amount of liquid 170 may be an aqueous liquid including a surfactant. The metered amount of liquid 170 may be saline. The metered amount of liquid 170 may be saline including a surfactant. The metered amount of liquid 170 may be saline including 0.005% to 2% by weight of a surfactant. The metered amount of liquid 170 or the liquid reservoir may have a volume in the range of 50 microliters to 500 microliters.

[0041] The porous sample collection medium 150 may be fixed within the housing 110 along the airflow channel 116. The exhaled airflow 160 passes through the thickness of the porous sample collection medium 150. The sample collection device 100 is configured to allow a user to breathe comfortably into the sample collection device 100 while minimizing the pressure drop across the porous sample collection medium 150. For example, a user may breathe into the sample collection device 100 at a rate of less than 85 liters / minute, or less than 50 liters / minute, or less than 35 liters / minute, or less than 24 liters / minute, or less than 10 liters / minute, and experience a pressure drop across the porous sample collection medium 150 of 70 mm water column or less, or 50 mm water column or less, or 25 mm water column or less, or 10 mm water column or less, or 5 mm water column or less.

[0042] The porous sample collection medium 150 at least partially occludes the airflow channel 116. The porous sample collection medium 150 may occlude the airflow channel 116. The porous sample collection medium 150 may have a major plane that is perpendicular to the direction of the exhaled airflow 160 through the thickness of the porous sample collection medium 150.

[0043] The porous sample collection medium 150 is secured within the airflow channel 116 and is spaced from each of the air outlet end 114 and mouthpiece end 112 to prevent a user from touching and contaminating the porous sample collection medium 150. The housing 110 has a length value L from the mouthpiece end 112 to the air outlet end 114, and the porous sample collection medium 150 is recessed from both the mouthpiece end 112 and the air outlet end 114 by at least 20% of the length value L, or at least 25% of the length value L, or at least 30% of the length value L, or at least 35% of the length value L, or in the range of 25%-50% of the length value L.

[0044] The porous sample collection medium 150 may be a non-woven material configured to filter or capture pathogens or viruses from the exhaled airflow 160. The porous sample collection medium 150 may be a non-woven filtration layer or material having an electrostatic charge configured to filter or capture pathogens or viruses from the exhaled airflow 160. The porous sample collection medium 150 may be a hydrophobic non-woven filtration layer or material configured to filter or capture pathogens or viruses from the exhaled airflow 160. The porous sample collection medium 150 may be a hydrophobic non-woven filtration layer or material having an electrostatic charge configured to filter or capture pathogens or viruses from the exhaled airflow 160.

[0045] 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.

[0046] The porous sample collection medium 150 may be formed from a polymeric material. The porous sample collection medium 150 may be formed from a polyolefin. The porous sample collection medium 150 may be formed from a polypropylene. One exemplary porous sample collection medium 150 is commercially available from 3M Company (St. Paul MN, USA) under the trade name FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus Air Filter Merv 12-14, or Merv 13.

[0047] Porous sample collection medium 150 may be formed from polylactide (PLA), such as, for example, 6100D from NatureWorks LLC 15305 Minnetonka Blvd Minnetonka, MN 55345. Exemplary nonwoven filtration layers or materials for use in or as porous sample collection medium 150 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.

[0048] The porous sample collection medium 150 may have a thickness (orthogonal to the major planar surface area) in the range of 200 micrometers to 1000 micrometers, or 250 micrometers to 750 micrometers. The porous sample collection medium 150 may have a major planar surface area in the range of about 1 cm2 to about 4 cm2, or about 2 cm2 to about 3 cm2, sufficient to fill the cross-section of the airflow channel 116. The airflow channel 116 may have a cross-sectional area in the range of about 1 cm2 to about 4 cm2, or about 2 cm2 to about 3 cm2.

[0049] The porous sample collection medium 150 defines a major surface area value and the liquid reservoir or quantity of liquid 170 defines a volume value, which when divided by the surface area value may be in the range of 10 microliters / cm2 to 400 microliters / cm2, or 10 microliters / cm2 to 250 microliters / cm2, or 50 microliters / cm2 to 150 microliters / cm2.

[0050] In some embodiments, the sample collection device 100 further includes a pre-filter or screen (not shown) located within the housing 110 and upstream of the porous sample collection medium 150 to trap solid matter or debris (e.g., food particles, etc.) from becoming entrained in the porous sample collection medium 150. The pre-filter or screen (not shown) may be secured within the housing 110 along the airflow channel 116 and between the mouthpiece end 112 and the porous sample collection medium 150. In some embodiments, the pre-filter or screen includes one or more flow openings therethrough. The exhaled airflow passes through the thickness of the pre-filter or screen. The pre-filter or screen at least partially blocks the airflow channel 116. In some cases, the pre-filter or screen may have a major plane (not shown) that is perpendicular to the direction of the exhaled airflow (not shown) passing through the thickness of the pre-filter or screen. The pre-filter or screen may be a non-woven layer configured to filter out relatively large particles from the exhaled airflow passing through the pre-filter or screen. In some cases, the prefilter or screen may be a nonwoven layer that does not have a static charge. In some embodiments, the prefilter or screen does not filter or capture significant amounts of viral or pathogenic material, but rather allows them to pass through the prefilter or screen. In some embodiments, the prefilter or screen is made from or includes at least one of a plastic mesh, a woven netting, a needle-tacked fibrous web, a knitted mesh, an extruded netting, and / or a carded or spunbonded cover stock.

[0051] To test a group of samples in one assay 180 , two or more sample collection devices 100 may be stacked end-to-end to apply liquid onto two or more porous sample collection media 150 .

[0052] The present disclosure is also directed to a sample collection system. The sample collection system includes the sample collection device 100 described above and an assay 180 configured to receive fluid from the sample collection device 100. The assay 180 may be a separate entity from the sample collection device 100. The assay 180 may be configured to receive the liquid 170 from the sample collection device 100.

[0053] Assay 180 may be a flow assay, such as a lateral flow assay or a vertical flow assay. Assay 180 may detect a virus, pathogen, or other analyte of interest. Assay may be, for example, a nucleic acid amplification (PCR, isothermal), immunoassay, etc. Assay 180 may include a test result window that indicates the presence or absence of a virus or pathogen.

[0054] 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 the 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.

[0055] The present disclosure also relates to a kit that includes the sample collection device described above and instructions for collecting a sample. The kit may be a package provided to a user to complete the sample collection process.

[0056] The kit instructions are blowing into an airflow channel of the housing to capture the sample within the porous sample collection medium; an air outlet end cap replaceably coupled to the air outlet end to seal the air outlet end; Flowing the liquid through the porous sample collection medium; Instructions may be included for joining a mouthpiece end cap to the mouthpiece end to seal the mouthpiece end.

[0057] According to another embodiment, the method includes flowing exhaled breath through a porous sample collection medium that is disposed within an airflow channel to form a loaded porous sample collection medium. A measured amount of liquid is then flowed through the loaded porous sample collection medium disposed within the airflow channel to form an eluent and contain the eluent. The eluent may then be tested using an assay.

[0058] The method may include flowing exhaled air into the sample collection device described above, forming a loaded porous sample collection medium, then sealing the air outlet end with an air outlet cap, then flowing liquid through the loaded porous sample collection medium, forming an eluent, and then sealing the mouthpiece end with a mouthpiece end cap.

[0059] The method may further include testing the eluent with an assay. The testing may include testing the eluent for the presence of a virus or pathogen. The method may include flowing a measured amount of liquid ranging from 50 microliters to 400 microliters through a loaded porous sample collection medium disposed in the airflow channel. The method may include flowing a measured amount of aqueous liquid including a surfactant through a loaded porous sample collection medium disposed in the airflow channel. The method may include squeezing the housing, air outlet end cap, or mouthpiece end cap to force the eluent through a nozzle or liquid dropper on the mouthpiece end cap.

[0060] 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 a mouthpiece end to an air outlet end, the housing defining an airflow channel from the mouthpiece end to the air outlet end, the mouthpiece end configured to receive an exhaled airflow; a porous sample collection medium secured within the housing along the airflow channel; a mouthpiece end cap replaceably coupled to the mouthpiece end; an air outlet end cap replaceably coupled to the air outlet end, Sample collection device.

2. The sample collection device of claim 1 , wherein one of the mouthpiece end cap and the air outlet end cap comprises a nozzle or liquid dropper.

3. 3. The sample collection device of claim 1 or 2, wherein one of the mouthpiece end cap or the air outlet end cap comprises a liquid reservoir having a measured amount of liquid.

4. The sample collection device of claim 3 , wherein the liquid reservoir defines a volume in the range of 50 microliters to 500 microliters.

5. The porous sample collection medium defines a surface area value, the fluid reservoir defines a volume value, and 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 The sample collection device of claim 4 , wherein the concentration is in the range of

6. The sample collection device of claim 2 , wherein the nozzle or liquid dropper further comprises a sealing cap configured to close the nozzle or liquid dropper.

7. The sample collection device of claim 2 , wherein the housing, the mouthpiece end cap, or the air outlet end cap is configured to be squeezed by a user to force liquid from the airflow channel through the nozzle or liquid dropper.

8. The sample collection device of any one of claims 1 to 7, wherein the porous sample collection medium comprises a non-woven filtration layer having an electrostatic charge.

9. The sample collection device of claim 8 , wherein the nonwoven filtration layer is hydrophobic.

10. 10. The sample collection device of claim 8 or 9, wherein the nonwoven filtration layer is formed from at least one of polypropylene or polylactic acid.

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