Sample acquisition 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 Art

[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] When Covid-19 reached pandemic status, it was important that the availability of diagnostic tests increased to help identify and control the severe disease. Even after the pandemic ended, this disease highlighted the need for such diagnostic tests to be widely available. Diagnostic tests used to test for the presence of viruses or other pathogens in the airway, throat, or nasopharynx typically involve inserting a swab into the back of the nose, the middle turbinate region of the nose, the anterior nostril, or into the throat to obtain a sample. The swab is then inserted into a container and either analyzed or sent to a laboratory for processing. Other diagnostic tests involve collecting a saliva sample and then placing it in a container. Currently available home viral tests (e.g., COVID-19 tests) involve nasal swabs and test kits (e.g., Ellume™ tests, Abbott™ BinaxNOW™ tests, and Lucira™ all-in-one test kits). 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 sample collection devices and testing processes described above present various challenges. For example, these available tests typically require the collection devices to be processed in a laboratory, increasing costs and delaying the delivery of results. Furthermore, many of the test methods require the sample collection mechanism to be a nasopharyngeal swab or other types of nasal or oral swab, which is uncomfortable for the user. This discomfort can cause users to avoid taking the test. In addition, the sample may be contaminated during transfer to a clean container or removal from the container. Due to the involvement of multiple steps and devices and the potential for sample contamination, such conventional methods and devices for sample collection and eluent testing can only be used by trained professionals (e.g., healthcare professionals) and may be complex for use by users with little or no training.

[0004] In some embodiments, the Disclosure provides an easy-to-use and inexpensive integrated sample collection and testing device in which sample collection and sample testing are performed within a single, integrated device that can be used by the public anywhere. Other embodiments of the 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, this integrated sample collection and testing device, and / or sample collection device, collects only bioaerosols. Bioaerosols may 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 mouth.

[0006] Furthermore, there is a need for inexpensive, easy-to-use, and reliable sample collection devices that can be used for testing whether the general public and / or medical professionals worldwide are shedding pathogens or viruses. These sample collection devices may be combined with test devices to determine whether or not pathogens or viruses are present in the collected samples.

[0007] Some aspects of the present disclosure describe a sample collection device including a housing extending from a mouthpiece end to an air outlet end, the housing defining an airflow channel from the exhalation receiving portion or mouthpiece end to the air outlet end, the exhalation receiving portion or mouthpiece end being configured to receive exhaled airflow. A porous sample collection medium is fixed within the housing along the airflow channel. An exhalation receiving portion or mouthpiece end cap is interchangeably coupled to the exhalation receiving portion or mouthpiece end, and an air outlet end cap is interchangeably coupled to the air outlet end.

[0008] This sample collection device may be combined with instructions for collecting samples to form a kit. The instructions may instruct the user to blow air into the airflow channel of the housing to capture the sample in the porous sample collection medium, seal the air outlet end by attaching a replaceable air outlet end cap to the air outlet end, flow the liquid through the porous sample collection medium, and seal the breath receiving portion or mouthpiece end by attaching a breath receiving portion or mouthpiece end cap to the breath receiving portion or mouthpiece end. The sealed sample collection device may be transported to a test site that is temporally or spatially distant from the time and location where 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 testing device. This system may, advantageously, be self-contained and sterile (unlike swabs, which can become contaminated during use, pose a biohazard risk during processing, and offer 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 for collecting a sample may include introducing exhaled air into a sample collection device, flowing a liquid through a loaded sample collection medium to form an eluent, and sealing the exhaled air receiving portion or mouthpiece end with an exhaled air receiving portion or mouthpiece end cap.

[0011] The eluent may be forced through a nozzle or liquid nozzle that defines a dropper or liquid dropper fixed to the exhalation receptacle or mouthpiece end cap, or to the exhalation receptacle or mouthpiece end. The discharged eluent may be tested using an assay such as a vertical assay or a lateral assay. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic side view of an exemplary sample collection device that collects samples. [Figure 2] This is a schematic side view of an exemplary sample collection device in which a liquid is flowing through a porous sample collection medium. [Figure 3] This is a schematic side view of an exemplary sample collection device in which liquid is flowed from a porous sample collection medium onto an assay.

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

[0014] As used herein, the term “substantial” is synonymous with “significantly” and can be understood to modify the following term by at least approximately 90%, at least approximately 95%, or at least approximately 98%. As used herein, the term “substantial” is synonymous with “significantly not” and can be understood to have the opposite meaning of “substantial,” that is, modifying the following term by 10% or less, 5% or less, or 2% or less.

[0015] The term “approximately” is used herein with numerical values ​​to include the normal variation in measurements that can be expected by those skilled in the art, and can be understood to have the same meaning as “approximately” and to cover a typical margin of error, such as ±5% of the stated value.

[0016] Terms such as "a," "an," and "the" are not intended to refer only to singular entities, but include general types that can be used to illustrate specific examples.

[0017] The terms "a," "an," and "the" are interchangeable with the term "at least one." The phrases "at least one of" and "including at least one of" following an enumeration refer to any one item in the enumeration, or any combination of two or more items in the enumeration.

[0018] As used herein, the term “or” is used in its ordinary sense, generally including “and / or,” unless otherwise specified. The term “and / or” means one or all of the enumerated elements, or any combination of two or more of the enumerated elements.

[0019] Enumerating a numerical range by endpoints includes all numbers contained within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc., or 10 or less includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). If a range of values ​​is "up to" or "at least" a specific value, that value is included within that range.

[0020] As used herein, "have," "having," "include," "including," "comprise," and "comprising" are used in an open-ended sense and usually mean "include, but not limited to." "Consisting essentially of" and "consisting of" will be understood to be encompassed by "comprising," etc. As used herein, "consisting essentially of" means, when relating to compositions, products, methods, etc., that the components of such compositions, products, methods, etc. are limited to the listed components and any other components that do not substantially affect the basic and novel properties (one or multiple) of such compositions, products, methods, etc.

[0021] The words “preferred” and “preferred” refer to embodiments that may provide a particular benefit in a particular situation. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are unhelpful, nor is it intended to exclude other embodiments from the scope of this disclosure, including the claims.

[0022] Any directions referred to in this specification, such as "front", "back", "top", "bottom", "left", "right", "upper side", "lower side", and other directions and orientations are described in this specification for clarity with respect to the figures and do not limit the actual device or system, or the use of the device or system. A device or system as described in this specification can be used in several directions and orientations.

[0023] The terms "downstream" and "upstream" refer to relative positions based on the direction of the 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.

Mode for Carrying Out the Invention

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

[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, and the mouthpiece end being configured to receive an exhaled airflow. A porous sample collection medium is fixed along the airflow channel within the housing. A mouthpiece end cap is removably coupled to the mouthpiece end, and an air outlet end cap is removably coupled to the air outlet end.

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

[0027] The porous sample collection medium is shown herein as defining a planar element, but it is understood that the porous sample collection medium can define any shape when arranged along an airflow channel within the housing. 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 the medium to about 1 pleat per 2 mm of the 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 the device housing along an airflow channel defined by the device housing. When a sample is collected on the porous sample collection medium, the open end of the housing can be sealed for testing at a future time and / or at a location remote from the sample collection location. After one or both open ends of the housing have been sealed, a liquid can be passed through the porous sample collection medium.

[0029] One end 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 retain the liquid within the housing for testing at a time and / or away from the sample collection site. The nozzle or liquid dropper provides a convenient way to place droplets from the housing onto the assay. Preferably, part of the housing, or one or both of the end caps, may be "compressible" to push the liquid out of the sample collection device through the nozzle or liquid dropper.

[0030] Figure 1 is a schematic side view of a sample collection device 100 collecting a sample. Figure 2 is a schematic side view of an exemplary sample collection device 100 flowing liquid 170 through a porous sample collection medium 150. Figure 3 is a schematic side view of an exemplary sample collection device 100 flowing 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, and the mouthpiece end 112 is configured to receive an exhaled airflow 160 (e.g., from the nose, mouth, or both). A porous sample collection medium 150 is fixed within the housing 110 along the airflow channel 116. A mouthpiece end cap 120 is interchangeably coupled to the mouthpiece end 112, and an air outlet end cap 125 is interchangeably coupled to the air outlet end 114.

[0032] The housing 110 may define an open cylindrical airflow channel 116 extending along the longitudinal axis by a length value L 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 value L from the mouthpiece end 112 to the air outlet end 114. The open cylindrical airflow channel 116 may have a diameter that decreases along the length value L and taper from the mouthpiece end 112 to the air outlet end 114. The open cylindrical airflow channel 116 may have a diameter that increases along the length value L and taper 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 the pressure of the user's fingers, similar to a squeeze bottle, in order to forcefully squeeze 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, the user can squeeze or compress the housing 110 at the location of 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 from the same type of material or from different types of material. The mouthpiece end cap 120 and / or the air outlet end cap 125 may be formed from 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 squeezed, like a squeeze bottle, or deformed or plastically deformed by the pressure of the user's fingers, in order to push 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 from a polymer.

[0035] The mouthpiece end cap 120 and the air outlet end cap 125 may be separate from the housing 110. The mouthpiece end cap 120 may be connected to the housing 110 via, for example, a tether 122. The air outlet end cap 125 may be connected to the housing 110 via, for example, a tether 127. The tether 122 may be connected to any part of the mouthpiece end cap 120. The tether 122 may be connected to any part of the housing 110. The tether 127 may be connected to any part of the air outlet end cap 125. The tether 127 may be connected to any part of the 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, or may be configured to allow liquid to flow out of the housing 110 in a droplet manner, similar to an eyedropper cap. 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 eyedropper cap. The nozzle or liquid dropper cap may be interchangeably attached to the nozzle or liquid dropper 124 to preserve the liquid in the sample collection device 100 for subsequent testing.

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

[0038] The liquid reservoir may be fixed to the housing 110 and allow the liquid to flow through the side wall of the housing 110. The liquid reservoir may be fixed to the mouthpiece end cap 120 and allow the liquid to flow through the wall of the mouthpiece end cap 120. The liquid reservoir may be fixed to the air outlet end cap 125 and allow the liquid to flow through the wall of the air outlet end cap 125.

[0039] Alternatively, the user may flow a fixed amount of liquid onto the porous sample collection medium 150 fixed inside the housing 110 by adding the liquid, for example, in a droplet manner, to one of the open ends of the housing 110. In one example, the user may blow air through the open end housing 110, then seal the air outlet end 114 with the air outlet end cap 125, then add a fixed amount of liquid 170 into the housing 110 through the open mouthpiece end 112, allowing the liquid 170 to flow through the porous sample collection medium 150 and remove any biological material present on the porous sample collection medium 150, after which the user may seal the mouthpiece end 112 with the mouthpiece end cap 120. The user may then squeeze the sample collection device 100 to forcefully push the liquid out of the housing 110 onto the assay 180 in a droplet manner, for example, through a nozzle or liquid dropper 124.

[0040] The quantitative liquid 170 may be an aqueous liquid. The quantitative liquid 170 may be an aqueous buffer solution. The quantitative liquid 170 may be an aqueous liquid containing a surfactant. The quantitative liquid 170 may be physiological saline. The quantitative liquid 170 may be physiological saline containing a surfactant. The quantitative liquid 170 may be physiological saline containing 0.005% to 2% by weight of a surfactant. The quantitative 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 the user to comfortably blow air into the sample collection device 100 while minimizing the pressure drop across the porous sample collection medium 150. For example, the user may blow air into the sample collection device 100 at a rate of less than 85 liters / min, or less than 50 liters / min, or less than 35 liters / min, or less than 24 liters / min, or less than 10 liters / min, and experience a pressure drop across the porous sample collection medium 150 of 70 mm of water column or less, or 50 mm of water column or less, or 25 mm of water column or less, or 10 mm of water column or less, or 5 mm of water column or less.

[0042] The porous sample collection medium 150 at least partially blocks the airflow channel 116. The porous sample collection medium 150 may completely block the airflow channel 116. The porous sample collection medium 150 may have a main plane perpendicular to the direction of the exhaled airflow 160 passing through the thickness of the porous sample collection medium 150.

[0043] The porous sample collection medium 150 is fixed within the airflow channel 116 and spaced apart from each of the mouthpiece ends 112 to prevent the 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 between 25% and 50% of the length value L.

[0044] The porous sample collection medium 150 may be a nonwoven fabric material configured to filter or capture pathogens or viruses from the exhaled airflow 160. The porous sample collection medium 150 may be a nonwoven fabric filter 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 nonwoven fabric filter 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 nonwoven fabric filter 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 materials having a water contact angle of 90 degrees or more, or approximately 90 to 170 degrees, or approximately 100 to 150 degrees. The water contact angle is measured using an automated contact angle tester and the ASTM D5727-1997 standard test method for surface wetting and absorption of sheet materials.

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

[0047] The porous sample collection medium 150 may be formed from polylactide (PLA), such as 6100D from NatureWorks LLC 15305 Minnetonka Blvd Minnetonka, MN 55345. Examples of nonwoven filtration layers or materials for use in or as the porous sample collection medium 150 include, for example, those described in U.S. Patents 7,947,142, 8,162,153, 9,139,940, and 10,273,612, all of which are incorporated herein by reference.

[0048] The porous sample collection medium 150 may have a thickness (perpendicular to the main plane) in the range of 200 micrometers to 1000 micrometers, or 250 micrometers to 750 micrometers. The porous sample collection medium 150 may have a main plane surface area in the range of about 1 cm² to about 4 cm², or about 2 cm² to about 3 cm², which is 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 1 cm² to about 4 cm², or about 2 cm² to about 3 cm².

[0049] The porous sample collection medium 150 has a defined main surface area value, and the liquid reservoir or quantitative liquid 170 has a defined volume value. The value obtained by dividing the volume value by the surface area value may be within 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 prefilter or screen (not shown) located upstream of the porous sample collection medium 150 within the housing 110 to capture solid material or debris (e.g., food particles) so that it does not adhere to the porous sample collection medium 150. The prefilter or screen (not shown) may be fixed 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 prefilter or screen includes one or more flow openings through which it passes. The exhaled airflow passes through the thickness of the prefilter or screen. The prefilter or screen at least partially blocks the airflow channel 116. In some cases, the prefilter or screen may have a principal plane (not shown) perpendicular to the direction of the exhaled airflow (not shown) passing through the thickness of the prefilter or screen. The prefilter or screen may be a nonwoven fabric layer configured to filter out relatively large particles from the exhaled airflow passing through the prefilter or screen. In some cases, the prefilter or screen may be a nonwoven fabric layer that does not have an electrostatic charge. In some embodiments, the prefilter or screen does not filter or capture a significant amount of viral or pathogenic material, but rather allows it to pass through the prefilter or screen. In some embodiments, the prefilter or screen is made from or includes at least one of the following: plastic mesh, woven net, needle-tucked fiber web, knitted mesh, extruded net, and / or carded or spunbonded coverstock.

[0051] To test a group of samples in a single assay 180, two or more sample collection devices 100 may be stacked with their ends aligned, and a liquid may be applied onto two or more porous sample collection media 150.

[0052] This disclosure also relates to a sample collection system. The sample collection system includes the sample collection device 100 described above and an assay 180 configured to receive a fluid from the sample collection device 100. The assay 180 may be a separate element from the sample collection device 100. The assay 180 may be configured to receive a 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 can detect viruses, pathogens, or other target specimens. The assay may be, for example, nucleic acid amplification (PCR, isothermal), an immunoassay, etc. Assay 180 may include a test result display window indicating the presence or absence of viruses or pathogens.

[0054] Assays, sometimes called lateral flow assays (LFAs) or vertical flow assays (VFAs), are generally paper-based platforms for the detection and quantification of samples in complex mixtures, where the sample is placed on a test device and the results are displayed within 5 to 30 minutes. The low development cost and ease of manufacture of LFAs have led to their expanded application in multiple fields 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 gene amplification products. A variety of biological samples can be tested using assays.

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

[0056] The kit instructions are: By blowing air into the airflow channel of the housing, the sample is captured within the porous sample collection medium. The air outlet end is sealed by attaching a replaceable air outlet end cap to the air outlet end. A liquid is passed through a porous sample collection medium. Instructions may include how to seal the mouthpiece end by attaching a mouthpiece end cap to the end of the mouthpiece.

[0057] According to another embodiment, the method includes flowing exhaled air through a porous sample collection medium. The porous sample collection medium is placed in an airflow channel to form a loaded porous sample collection medium. A quantitative amount of liquid is then flowed through the loaded porous sample collection medium placed in the airflow channel to form an eluent, which is then contained. The eluent may then be tested using an assay.

[0058] This 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 a liquid through the loaded porous sample collection medium, forming an eluent, and then sealing the mouthpiece end with a mouthpiece end cap.

[0059] This method may further include testing the eluent using an assay. The test may include testing the eluent for the presence of a virus or pathogen. This method may include flowing a quantitative amount of liquid in the range of 50 microliters to 400 microliters through a loaded porous sample collection medium placed in an airflow channel. This method may include flowing a quantitative amount of aqueous liquid containing a surfactant through a loaded porous sample collection medium placed in an airflow channel. This method may include compressing 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 referred to herein are expressly incorporated by reference unless they would directly contradict this disclosure. While specific embodiments are illustrated and described herein, it will be understood by those skilled in the art that such specific embodiments may be replaced by various alternative and / or equivalent embodiments without departing the scope of this disclosure. It should be understood that this disclosure is not unduly limited by the exemplary embodiments and examples described herein, and that such embodiments and examples are provided merely as illustrations within the scope of this disclosure, which is intended to be limited only by the claims set forth herein. In addition to each embodiment, the following embodiments are also described. (Note 1) A sample collection device, A housing extending from the mouthpiece end to the air outlet end, wherein the housing defines an airflow channel from the mouthpiece end to the air outlet end, and the mouthpiece end is configured to receive the exhaled airflow; A porous sample collection medium fixed within the housing along the airflow channel, A mouthpiece end cap that is interchangeably attached to the end of the mouthpiece, The system includes an air outlet end cap that is interchangeably connected to the aforementioned air outlet end, Sample acquisition device. (Note 2) The sample collection device according to Appendix 1, wherein one of the mouthpiece end cap and the air outlet end cap is equipped with a nozzle or a liquid dropper. (Note 3) The sample collection device according to Appendix 1 or 2, wherein one of the mouthpiece end cap or the air outlet end cap comprises a liquid reservoir having a fixed amount of liquid. (Note 4) The sample collection device described in Appendix 3, wherein the liquid reservoir defines a volume in the range of 50 microliters to 500 microliters. (Note 5) The porous sample collection medium defines a surface area value, the fluid reservoir defines a volume value, and the value obtained by dividing the volume value by the surface area value is 10 microliters / cm³. 2 ~400 microliters / cm³ 2 Alternatively, 10 microliters / cm³ 2 ~250 microliters / cm³ 2 A sample collection device as described in Appendix 4, which is within the range of the specified device. (Note 6) The sample collection device according to Appendix 2, further comprising a sealing cap configured to close the nozzle or liquid dropper. (Note 7) The sample collection device according to Appendix 2, wherein the housing, the mouthpiece end cap, or the air outlet end cap is configured to be squeezed by the user to push liquid out of the airflow channel through the nozzle or the liquid dropper. (Note 8) The sample collection device according to any one of the appendices 1 to 7, wherein the porous sample collection medium includes a nonwoven fabric filter layer having an electrostatic charge. (Note 9) The sample collection device described in Appendix 8, wherein the nonwoven fabric filter layer is hydrophobic. (Note 10) The sample collection device according to Appendix 8 or 9, wherein the nonwoven fabric filter layer is formed from at least one of polypropylene or polylactic acid. (Note 11) A sample collection device according to any one of the appendices 8 to 10, wherein the nonwoven fabric filter layer is pleated. (Note 12) The sample collection device according to any one of the appendices 8 to 11, wherein the nonwoven fabric filter layer has a thickness in the range of 200 to 1000 micrometers or 250 to 750 micrometers. (Note 13) The sample collection device according to any one of Appendix 3, 4, or 5, wherein the liquid reservoir contains a liquid which is at least one of an aqueous fluid, an aqueous buffer, an aqueous fluid containing a surfactant, physiological saline, or physiological saline containing a surfactant. (Note 14) The sample collection device according to any one of the appendices 1 to 13, further comprising a prefilter fixed within the housing along the airflow channel between the mouthpiece end and the porous sample collection medium. (Note 15) The sample collection apparatus according to any one of the appendices 1 to 14, wherein the housing has a length value L from the mouthpiece end to the air outlet end, and the porous sample collection medium is recessed at least 20% of the length value L from both the mouthpiece end and the air outlet end. (Note 16) A sample collection device according to any one of the appendices 1 to 15, wherein the housing is made of polymer. (Note 17) A sample collection device according to any one of the appendices 1 to 16, wherein the mouthpiece end cap is tethered to the housing. (Note 18) A sample collection device according to any one of the appendices 1 to 17, wherein the air outlet end cap is connected to the housing by a tether. (Note 19) A sample collection device described in any one of the appendices 1 to 18, An assay configured to receive liquid from the aforementioned sample collection device, A sample collection system equipped with the following features. (Note 20) The sample collection system described in Appendix 19, wherein the assay detects the presence of a virus, pathogen, or other target specimen. (Note 21) The sample collection system according to Appendix 19 or 20, wherein the assay is a lateral flow assay. (Note 22) The sample collection system according to Appendix 19 or 20, wherein the assay is a vertical flow assay. (Note 23) A sample collection device described in any one of the appendices 1 to 18, Instructions for collecting samples, A kit that includes this. (Note 24) The above instruction manual, By blowing air into the airflow channel of the housing, the sample is captured in the porous sample collection medium. The air outlet end is sealed by resizable coupling of the air outlet end cap to the air outlet end, A liquid is passed through a porous sample collection medium. The mouthpiece end cap is attached to the end of the mouthpiece to seal the end of the mouthpiece. The kit described in Appendix 23, including instructions for use. (Note 25) By introducing exhaled breath into the sample collection device described in any one of the appendices 1 to 18, a loaded porous sample collection medium is formed. The air outlet end is sealed with the air outlet cap, The process involves flowing a liquid through the pre-loaded porous sample collection medium to form an eluent, This includes sealing the end of the mouthpiece with the mouthpiece end cap, method. (Note 26) The method according to Appendix 25, further comprising testing the eluent using an assay. (Note 27) The method according to Appendix 25 or 26, wherein the flow of the liquid includes flowing a fixed amount of liquid in the range of 50 microliters to 400 microliters through the loaded porous sample collection medium placed in the airflow channel. (Note 28) The method according to Appendix 25 or 27, wherein the flow of the liquid includes flowing a fixed amount of aqueous liquid containing a surfactant through the loaded porous sample collection medium placed in the airflow channel. (Note 29) The method according to any one of the appendices 25 to 28, wherein the flow of exhaled air includes flowing exhaled air through a porous nonwoven electrostatic sample collection medium. (Note 30) The method according to Appendix 26, wherein the test detects the presence of a virus, pathogen, or other target specimen. (Note 31) The method according to any one of the appendices 25 to 30, further comprising compressing the housing, the air outlet end cap, or the mouthpiece end cap to bias the eluent through the nozzle on the mouthpiece end cap.

Claims

1. A sample collection device, A housing extending from the mouthpiece end to the air outlet end, wherein the housing defines an airflow channel from the mouthpiece end to the air outlet end, and the mouthpiece end is configured to receive the exhaled airflow; A porous sample collection medium fixed within the housing along the airflow channel, A mouthpiece end cap that is interchangeably attached to the end of the mouthpiece, The air outlet end cap is interchangeably connected to the aforementioned air outlet end, The mouthpiece end cap or the air outlet end cap is equipped with a liquid reservoir containing a fixed amount of liquid. Sample acquisition device.

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

3. The sample collection device according to claim 1 or 2, wherein the liquid reservoir defines a volume in the range of 50 microliters to 500 microliters.

4. The porous sample collection medium defines a surface area value, the liquid reservoir defines a volume value, and the value obtained by dividing the volume value by the surface area value is 10 microliters / cm³. ２ ~400 microliters / cm³ ２ Alternatively, 10 microliters / cm³ ２ ~250 microliters / cm³ ２ A sample collection device according to claim 3, which is within the range of the specified range.

5. A sample collection device, A housing extending from the mouthpiece end to the air outlet end, wherein the housing defines an airflow channel from the mouthpiece end to the air outlet end, and the mouthpiece end is configured to receive the exhaled airflow; A porous sample collection medium fixed within the housing along the airflow channel, A mouthpiece end cap that is interchangeably attached to the end of the mouthpiece, The air outlet end cap is interchangeably connected to the aforementioned air outlet end, One of the mouthpiece end cap and the air outlet end cap is equipped with a nozzle or a liquid dropper. A sample collection device further comprising a sealing cap configured to close the nozzle or liquid dropper.

6. The sample collection device according to claim 2, wherein the housing, the mouthpiece end cap, or the air outlet end cap is configured to be squeezed by the user to push liquid out of the airflow channel through the nozzle or the liquid dropper.

7. The sample collection device according to any one of claims 1 to 6, wherein the porous sample collection medium includes a nonwoven fabric filter layer having an electrostatic charge.

8. The sample collection device according to claim 7, wherein the nonwoven fabric filter layer is hydrophobic.

9. The sample collection device according to claim 7 or 8, wherein the nonwoven fabric filter layer is formed from at least one of polypropylene or polylactic acid.

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