Pathogen sample collection device

Abstract

The pathogen sample collection device includes a liquid container that defines a container volume and has an opening, and a certain volume of liquid eluent that is within the container volume and defines a liquid surface. The airflow conduit extends from an exhalation inlet end to a distal end. The airflow conduit extends through the opening. The distal end of the airflow conduit is disposed within a certain volume of liquid eluent or above the liquid surface, and the opening is provided with an air outlet.

Description

Technical Field

[0001] The present disclosure relates to a pathogen sample collection device. The present disclosure relates to a bioaerosol collection device.

Background Art

[0002] 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 posterior nasal cavity, the middle turbinate region of the nasal cavity, the anterior nares, or the throat to obtain a sample. The swab is then inserted into a container and sent to a laboratory for analysis or processing. Other diagnostic tests involve collecting a saliva sample and then placing it in a container. Currently available home virus tests (e.g., COVID-19 tests) involve nasal swabs and test kits (e.g., Ellume™ tests, Abbot™ 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] There is a need for an inexpensive, easy-to-use, reliable pathogen sample collection system that can be used by the general public to obtain a sample for testing for the presence of a target virus, target pathogen, or other target analyte in a collected sample. The sample collection system may include a sample collection device for directly collecting a sample from an exhaled air stream onto a sample collection liquid, and the sample collection device may be used to analyze the sample or transfer the sample to a testing facility.

[0004] It is desirable to provide a pathogen sample collection device that is easy to use. This device can advantageously be self - contained and optionally sterile. In a self - contained (and optionally sterile) device, contamination and background noise are reduced compared to swabs and other test collection devices that can be contaminated during use and / or testing, so the accuracy and reliability of pathogen testing can be improved.

[0005] It is desirable to directly capture airborne pathogens or biological samples without the need for a drying filter medium to be rinsed later and collect a sample for testing. This wet media sample can be tested directly after direct sample collection or sealed and optionally transferred for testing safely without contamination.

[0006] The pathogen sample collection device enables the direct capture of pathogens or biological samples from aerosols found in exhaled breath into a wet media or liquid media that can be directly tested or sealed, for example, for subsequent testing. By enabling the bio - aerosol to directly impinge on the elution fluid, the sample can be captured without the need to capture the biological sample with a drying filtration device or a dry swab that would later have to be rinsed off. The collected sample can then be tested for pathogens. Pathogens refer to infectious microorganisms or infectious agents such as viruses, bacteria, protozoa, prions, viroids, or fungi. In an exemplary embodiment, the pathogen is a virus.

[0007] According to one embodiment, the pathogen sample collection device includes a liquid container that defines a container volume and has an opening, and a volume of a liquid eluent that is within the container volume and defines a liquid surface. An air flow conduit extends from an exhalation inlet end to a distal end. The air flow conduit extends through the opening. The distal end of the air flow conduit is disposed within the volume of the liquid eluent or above the liquid surface, and the opening comprises an air outlet.

[0008] According to another embodiment, the pathogen sample collection device includes a liquid container that defines a container volume and has an opening, and a volume of liquid eluent that is within the container volume and defines a liquid surface. The airflow conduit extends from an exhalation inlet end to a distal end. The airflow conduit is configured to allow only a one-way flow out of the distal end of the airflow conduit. The airflow conduit extends through the opening. The distal end of the airflow conduit is disposed within the volume of the liquid eluent or above the liquid surface, and the opening includes an air outlet.

[0009] According to another embodiment, the pathogen sample collection device includes a liquid container that defines a container volume and has an opening. The container volume is less than 20 mL. The volume of the liquid eluent within the container volume defines a liquid surface. The airflow conduit extends from an exhalation inlet end to a distal end. The airflow conduit extends through the opening. The distal end of the airflow conduit is disposed within the volume of the liquid eluent or above the liquid surface, and the opening includes an air outlet.

[0010] The pathogen sample collection device is configured to form a jet of exhaled air flow that contacts a volume of liquid eluent by the user sucking into the airflow conduit, and capture a sample from the jet of exhaled air flow within the volume of the liquid eluent. The distal end of the airflow conduit may be disposed within the volume of the liquid eluent. The distal end of the airflow conduit may be disposed within a volume of the liquid eluent or above the liquid surface. The container volume may be less than about 15 milliliters (mL), or may be in the range of about 1 to about 15 mL. The volume of the liquid eluent may be less than 5 mL, or may be in the range of 1 mL to 5 mL.

[0011] According to another embodiment, a method of obtaining a pathogen sample using a sample collection device. The sample collection device includes a liquid container that defines a container volume and has an opening, a volume of liquid eluent that is within the container volume and defines a liquid surface, and an air flow conduit that extends from an exhalation inlet end to a distal end. The distal end of the air flow conduit is disposed within the volume of the liquid eluent or above the liquid surface. The method includes the step of sucking in at the exhalation inlet end to form a jet of exhaled air flow exiting from the distal end of the air flow conduit. The jet of exhaled air flow contacts the volume of the liquid eluent to capture a sample from the jet of exhaled air flow within the volume of the liquid eluent and form a liquid sample.

[0012] According to one embodiment, a kit for collecting a sample from respiration includes a sample collection device and instructions for collecting a respiration sample.

Brief Description of the Drawings

[0013]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 5

Figure 6

[0014] Definition All scientific and technical terms used in this specification have the meanings commonly used in the relevant technical field, unless otherwise specified. The definitions provided in this specification are for the purpose of facilitating the understanding of specific terms frequently used herein and are not intended to limit the scope of the present disclosure.

[0015] Unless otherwise indicated, the terms "polymer" and "polymer material" include, but are not limited to, organic homopolymers, copolymers (such as block copolymers, graft copolymers, random copolymers, and alternating copolymers, etc.), terpolymers, etc., as well as blends and modified forms thereof. Further, unless otherwise specifically limited, the term "polymer" shall be taken to encompass all possible geometric arrangements of the material. These arrangements include, but are not limited to, isotactic symmetry, syndiotactic symmetry, and atactic symmetry.

[0016] 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 exhalation inlet end, and the most downstream element of the device is the outlet portion.

[0017] All headings described in this specification are for the convenience of the reader and are not used to limit the meaning of the text following the heading, unless otherwise stated.

[0018] The term "i.e." is used herein as an abbreviation of the Latin phrase id est and means "that is", and the term "e.g." is used as an abbreviation of the Latin phrase exempli gratia and means "for example".

[0019] All scientific and technical terms used in this specification have the meanings commonly used in the relevant technical field, unless otherwise specified. The definitions provided in this specification are for facilitating the understanding of specific terms frequently used herein, and are not intended to limit the scope of the present disclosure.

[0020] The term "about" is used herein with a numerical value to include the normal variations in the measured values expected by those skilled in the art, has the same meaning as "approximately", and can be understood to cover a typical margin of error such as ±5% of the stated value. Further, unless otherwise indicated, all numbers expressing amounts and all terms expressing directions / orientations (e.g., vertical, horizontal, parallel, right angle, etc.) used in this specification and in the "claims" are to be understood as being modified in all instances by the term "about".

[0021] Terms such as "a", "an", and "the" are not intended to refer only to a single entity, but include general types that can be used to exemplify specific examples.

[0022] The terms "a", "an", and "the" are used interchangeably with the term "at least one". The phrases "at least one of" and "comprising at least one of" following a listing refer to any one of the items in the listing and any combination of two or more of the items in the listing.

[0023] As used in this specification, the term "or" is generally used in its ordinary sense including "and / or", unless specifically stated otherwise to the contrary. The term "and / or" means one or all of the listed elements, or any combination of two or more of the listed elements.

[0024] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 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.). When a range of values is specified as being "up to" or "at least" a particular value, that value is included within the range.

[0025] As used herein, terms such as "have", "having", "include", "including", "comprise", "comprising", etc. are used in an open-ended sense and generally mean "including but not limited to". It will be understood that terms such as "consisting essentially of", "consisting of", etc. are subsumed within "comprising", etc. As used herein, "consisting essentially of", when referring to a composition, product, method, etc., means that the components of that composition, product, method, etc. are limited to the recited components and any other components that do not substantially affect the basic and novel properties (singular or plural) of that composition, product, method, etc.

[0026] As used herein, the term "substantially" has the same meaning as "significantly" and can be understood to modify the subsequent term by at least about 90%, at least about 95%, or at least about 98%. As used herein, the term "not substantially" has the same meaning as "not significantly" and can be understood to have the opposite meaning of "substantially", i.e., to modify the subsequent term by 10% or less, 5% or less, or 2% or less.

[0027] The terms "preferred" and "preferably" refer to embodiments that may provide certain benefits in certain circumstances. However, other embodiments may also be preferred in the same or other circumstances. Furthermore, the description of one or more preferred embodiments is not intended to suggest that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0028] The directions such as "front", "rear", "top", "bottom", "left", "right", "upper side", "lower side", and other directions and orientations referred to herein are all described herein for the sake of 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.

[0029] The directions such as "top", "bottom", "left", "right", "upper side", "lower side", and other directions and orientations referred to herein are all described herein for the sake of 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.

[0030] The term "pathogen" refers to infectious microorganisms or infectious agents such as viruses, bacteria, protozoa, prions, viroids, or fungi.

DETAILED DESCRIPTION OF THE INVENTION

[0031] The present disclosure relates to a pathogen sample collection device. The present disclosure relates to a bioaerosol sample collection device.

[0032] The pathogen sample collection device described herein directly captures airborne pathogens or biological samples using a wet medium or a liquid eluent without the need for a dry filter medium. This wet medium sample may be directly tested after direct sample collection, or it may be sealed and optionally transferred for testing safely without contamination. Directly capturing airborne pathogens or biological samples using a wet medium or eluent that can be directly tested reduces or eliminates the potential for contamination and errors, and improves the reliability of the samples and tests.

[0033] The pathogen sample collection device described herein eliminates the need for any dry media currently used to capture pathogens or biological samples from a consumer's airway or breath.

[0034] The pathogen sample collection device includes a liquid container that defines a container volume and has an opening, a volume of liquid eluent within the container volume that defines a liquid surface, and an air flow conduit that extends from an exhalation inlet end to a distal end. The distal end of the air flow conduit is disposed within the volume of the liquid eluent or above the liquid surface.

[0035] The pathogen sample collection device includes a liquid container that defines a container volume and has an opening, a volume of liquid eluent within the container volume that defines a liquid surface, and an air flow conduit that extends from an exhalation inlet end to a distal end. The air flow conduit may be configured to allow only a unidirectional flow out of the distal end. The distal end of the air flow conduit is disposed within the volume of the liquid eluent or above the liquid surface.

[0036] The pathogen sample collection device includes a liquid container that defines a container volume and has an opening. The container volume may be less than 20 mL. The volume of the liquid eluent within the container volume defines a liquid surface. The air flow conduit extends from an exhalation inlet end to a distal end. The air flow conduit extends through the opening. The distal end of the air flow conduit is disposed within the volume of the liquid eluent or above the liquid surface, and the opening includes an air outlet. The distal end of the air flow conduit may be in the same plane as the liquid surface.

[0037] The airflow conduit has an exhalation inlet end configured to fit with a consumer's mouth or nose as needed. The distal end of the airflow conduit may be adjacent to the liquid surface or liquid level of the liquid eluent of its volume. The distal end of the airflow conduit may be separated from the liquid surface. The distal end of the airflow conduit may be separated from the liquid surface by a distance in the range of at least 1 mL, or in the range of 1 mL to 10 mL, or in the range of 1 mL to 5 mL, or in the range of 1 mL to 3 mL.

[0038] The distal end of the airflow conduit may be disposed within the liquid surface or liquid level of the liquid eluent of its volume. The distal end of the airflow conduit may be above the liquid surface or liquid level of the liquid eluent of its volume. The applicant has found that the jet of exhaled air impinging on the surface of the liquid eluent of its volume captures pathogens or biological samples from the consumer's exhalation.

[0039] The airflow conduit may have a first opening diameter at the exhalation inlet end and a second opening diameter at the distal end, and the second opening diameter is smaller than the first opening diameter. This configuration can increase the velocity of the exhaled air flowing out from the distal end of the airflow conduit compared to the airflow velocity at the exhalation inlet end. This increase in velocity of the exhaled air flowing out from the distal end of the airflow conduit can form a jet of exhaled air current that can impinge on or within the liquid surface of the liquid eluent of its volume.

[0040] The airflow conduit may include a lid or coupling mechanism for fitting with the opening of the liquid container. The coupling mechanism and the opening of the liquid container may have complementary coupling mechanisms to provide a secure attachment of the coupling mechanism to the opening of the liquid container. The airflow conduit may be integrally formed with the lid or coupling mechanism. The airflow conduit may be fixed to the lid or coupling mechanism.

[0041] The lid or coupling mechanism may be configured to engage with the opening using a snap-fit mechanism. The lid or coupling mechanism may be configured to engage with the opening using a threaded coupling mechanism or a screw-fit mechanism. Both the opening and the lid or coupling mechanism may have complementary threaded coupling mechanisms or screw-fit mechanisms.

[0042] This lid or coupling mechanism may include an air outlet that allows air to escape from the liquid container when the air duct is fitted to the liquid container. The terms "lid" and "coupling mechanism" are used interchangeably herein.

[0043] The coupling mechanism may have an angled surface such as a frustoconical shape that mates with the opening of the liquid container. The coupling mechanism may have one or more radial ribs that engage with the opening of the liquid container. The radial ribs may include a first rib having a first diameter adjacent to the coupling end and a second rib having a second diameter larger than the first diameter.

[0044] The air duct may be configured to allow only a one-way flow exiting from the distal end. This mechanism reduces or prevents backflow of the liquid eluent toward the exhalation inlet end of the air duct. The air duct can include a one-way flow valve or a check valve. The one-way flow valve may include a ball check valve, a swing check valve, an in-line check valve, an inclined disk check valve, a lift check valve, etc.

[0045] The exhalation inlet end of the air duct may form an exhalation piece or may be coupled to an exhalation piece such as a mouthpiece or a nose piece. The exhalation piece may be configured to accommodate exhalation passing through either the mouth or the nose. The nose exhalation piece may be configured to surround the consumer's nose and allow nasal exhalation to be collected and transmitted through the air duct of the pathogen sample collection device.

[0046] The air flow conduit coupling mechanism may be fitted or coupled to the opening of the liquid container using any suitable mechanism. For example, the coupling mechanism and the opening may be coupled by bayonet coupling, interference fit, snap fit, or screw coupling. In one embodiment, the coupling mechanism and the opening are coupled by bayonet coupling. When configured to bayonet couple, the coupling mechanism may include one or more protrusions, and the opening may include one or more corresponding grooves constructed to receive and guide the one or more protrusions. Alternatively, one or more protrusions may be on the opening, and one or more grooves may be on the coupling mechanism.

[0047] The air flow conduit and the liquid container may be formed of any suitable material. The housing may be formed of a rigid material such as plastic, metal, glass, etc., or a combination thereof.

[0048] The liquid container can hold a small amount of liquid. The liquid container may have a volume typical of a medical collection vial. The liquid container may have a volume of less than 50 mL, or less than 40 mL, or less than 30 mL, or less than 20 mL, or less than 15 mL, or in the range of 1 mL to 50 mL, or in the range of 2 mL to 20 mL, or in the range of 5 mL to 10 mL.

[0049] The volume of the liquid eluent may be less than 25 mL, or less than 15 mL, or less than 10 mL, or less than 5 mL, or in the range of 1 mL to 25 mL, or in the range of 1 mL to 10 mL, or in the range of 1 mL to 5 mL. Collection of the pathogen sample may be more effective in a small amount of liquid eluent since the sample is concentrated in a small amount.

[0050] The sample collection system may be provided as a kit. The kit may include a sample collection device as described above and one or more opening adapters configured to seal the collected sample or direct the sample into a test device. For example, when a sample is collected and the airflow conduit is removed from the liquid container, the consumer can attach a seal lid to the opening of the liquid container to store the collected sample for subsequent testing. Alternatively or additionally, when a sample is collected and the airflow conduit is removed from the liquid container, the consumer can attach a dropper lid to the opening of the liquid container and drip and dispense the collected sample onto a test device.

[0051] The liquid eluent may be an aqueous liquid. The liquid eluent may be a buffer solution. The liquid eluent may be an aqueous buffer solution. The liquid eluent may be physiological saline. The liquid eluent may contain a surfactant. The liquid eluent (e.g., buffer or physiological saline) may contain 0.1 wt% or more or 0.5 wt% or more, and up to 1 wt% or up to 2 wt% of a surfactant.

[0052] FIG. 1 is a schematic side view of a pathogen sample collection device 100 according to one embodiment. FIG. 2 is a schematic side view of the pathogen sample collection device 100 collecting a pathogen sample. FIG. 3 is a schematic side view of the pathogen sample collection device 100 with the airflow conduit 120 removed from the liquid container 102.

[0053] The pathogen sample collection device includes a liquid container 102 that defines a container volume and has an opening 105. The container volume may be less than 20 mL. A volume of liquid eluent 110 is retained within the container volume and defines a liquid surface 112. The airflow conduit 120 extends from an exhalation inlet end 122 to a distal end 124. The airflow conduit 120 may be configured to allow only a one-way flow exiting from the distal end 124. The distal end 124 of the airflow conduit is disposed within the volume of the liquid eluent 110 or above the liquid surface 112.

[0054] The airflow conduit 120 is configured to allow only a one-way flow exiting from the distal end 124. This mechanism reduces or prevents the backflow of the liquid eluent 110 towards the exhalation inlet end 122 of the airflow conduit 120. The airflow conduit 120 may include a one-way flow valve 130 or a check valve 130. The one-way flow valve 130 may include a ball check valve, a swing check valve, an in-line check valve, an inclined disk check valve, a lift check valve, etc.

[0055] The distal end 124 of the airflow conduit 120 may be disposed within the volume of the liquid eluent 110 such that the entire distal end 124 of the airflow conduit 120 is immersed within the volume of the liquid eluent 110. In these embodiments, the exhaled airflow 140 enters through the exhalation inlet end 122 and flows through the airflow conduit 120 to the distal end 124. This exhaled airflow exiting the distal end 124 forms a jet 145 of exhaled airflow that penetrates the volume of the liquid eluent 110. Thus, pathogens or biological samples are captured by the liquid eluent 110. The exhaled airflow moves from the liquid eluent 110, exits the liquid container 102, and forms an exhalation outlet airflow 149 through an optional air outlet passing through the coupling mechanism 125.

[0056] The distal end 124 of the airflow conduit 120 may be in the same plane as the liquid surface 112 of the liquid eluent 110, and the distal end 124 of the airflow conduit 120 is not below the liquid surface 112 of the liquid eluent 110. In these embodiments, the exhaled airflow 140 enters through the exhalation inlet end 122 and flows through the airflow conduit 120 to the distal end 124. This exhaled airflow exiting the distal end 124 collides with the surface and forms a jet 145 of exhaled airflow that can penetrate the liquid surface 112 of the liquid eluent 110. Thus, pathogens or biological samples are captured by the liquid eluent 110. The exhaled airflow moves from the liquid eluent 110, exits the liquid container 102, and forms an exhalation outlet airflow 149 through an optional air outlet passing through the coupling mechanism 125.

[0057] The distal end 124 of the airflow conduit 120 may be above the liquid surface 112 of the liquid eluent 110, such that the distal end 124 is spaced from the liquid surface 112 of the liquid eluent 110. In these embodiments, the exhaled airflow 140 enters the exhalation inlet end 122 and flows through the airflow conduit 120 to the distal end 124. This exhaled airflow exiting the distal end 124 strikes the surface to form a jet 145 of exhaled airflow that can penetrate the liquid surface 112 of the liquid eluent 110. Thus, the pathogen or biological sample is captured by the liquid eluent 110. The exhaled airflow moves from the liquid eluent 110, exits the liquid container 102, and forms an exhalation outlet airflow 149 through an optional air outlet passing through the coupling mechanism 125.

[0058] When the pathogen sample is directly collected within its volume of the liquid eluent 110, the airflow conduit 120 is removed from the liquid container 102 and then tested or sealed and subsequently tested.

[0059] FIG. 4A is a schematic side view of the pathogen sample collection device 100 with the opening 105 of the liquid container 102 sealed with a vial cap or seal cap 150. FIG. 4B is a schematic side view of the pathogen sample collection device 100 with the opening 105 of the liquid container 102 closed with a dropper cap 160.

[0060] The seal cap 150 or the dropper cap 160 may be coupled to the opening 105 via any useful mechanism. For example, the seal cap 150 or the dropper cap 160 may be coupled to the opening 105 by a bayonet connection, an interference fit, a snap fit, or a screw connection.

[0061] FIG. 5 is a schematic side view of an embodiment of the air duct 120 including an optional air-permeable layer 170 disposed around the air duct 120. When present, the air-permeable layer 170 may function as a liquid barrier to prevent bubbles or liquid splashing from exiting the liquid container 102 during pathogen sample collection. The air-permeable layer 170 may not absorb the liquid eluent 110. The air-permeable layer 170 may be disposed between the liquid surface 112 of the liquid container 102 and the opening 105. The air-permeable layer 170 may extend substantially along the entire inner diameter of the liquid container 102.

[0062] FIG. 6 is a schematic side view of an embodiment of the air duct 120 including a nasal mechanism 128 and an angled coupling surface 125 having ribs 129. The coupling mechanism 125 may define a frustoconical portion and a plurality of ribs 129 extending from the frustoconical portion. The plurality of ribs 129 may include radial ribs 129. The radial ribs 129 may define a first rib having a first diameter adjacent the coupling end and a second rib having a second diameter larger than the first diameter, as shown in FIG. 6.

[0063] In the illustrated embodiment, the coupling mechanism 125 includes a frustoconical portion and one or more rings or ribs 129 extending outwardly from the frustoconical portion. The frustoconical portion may taper towards one end, as shown. The ribs 129 engage at least partially with the inner surface of the opening 105 of the liquid container 102. According to one embodiment, the ribs 129 may be deformable. That is, when the coupling mechanism 125 is inserted into the opening 105 of the liquid container 102, the ribs 129 deform beyond their yield point to provide an interference fit into the opening 105 of the liquid container 102. The frustoconical portion 125 may also be formed by a thin wall that further provides flexibility to assist in the fit.

[0064] The plurality of ribs 129 may have different sizes or diameters. The size of the rib 129 may gradually increase such that it starts with a minimum diameter adjacent to one end and ends with a maximum diameter adjacent to the other end. That is, the plurality of ribs 29 may include at least a first rib having a first diameter adjacent to one end and a second rib having a second diameter larger than the first diameter and further away from the one end. The plurality of ribs 129 may further include a plurality of additional ribs with gradually increasing diameters. The ribs 129 of different sizes and the frustoconical portion 125 that tapers enable connection to the openings 105 of liquid containers 102 of different inner diameters regardless of the specific dimensions of the threads or outer diameters of the coupling mechanism 125.

[0065] In the illustrated embodiment, the rib 129 is a radial rib extending circumferentially around the frustoconical portion 125. However, in some embodiments, the rib 129 has a different shape that facilitates a mechanical interference fit with the inside of the liquid container 102. For example, the rib 129 may only partially extend around the frustoconical portion 125, or may form fins extending axially along the frustoconical portion 125, or may form wedges.

[0066] The pathogen sample collection device 100 may be utilized by a consumer by exhaling into the exhalation inlet end 122 of the air flow conduit 120 through either the nose or mouth, causing the exhaled air stream 145 or the jet of the exhaled air stream 145 exiting from the distal end 124 of the air flow conduit 120 to collide. The jet 145 of the exhaled air stream contacts the volume of the liquid eluent 110 and captures a sample from the jet of the exhaled air stream 145 within the volume of the liquid eluent 110.

[0067] The consumer may then test the collected sample or seal the collected sample for subsequent testing.

[0068] The sample collection device may further comprise a machine-readable optical label. Such labels may include, for example, barcodes and QR (Quick Response) codes. The machine-readable optical label may be configured to identify the device. The results may be read and recorded using an electronic reader capable of reading the machine-readable optical label. The electronic reader may be, for example, a smartphone, a tablet, a laptop, or a barcode reader or a QR code reader. The electronic reader may further be used to transmit the results to, for example, a healthcare worker or a database.

[0069] In another configuration, the kit may include a sample collection device and instructions for collecting a sample. The instructions may include instructions for breathing into the sample collection device and then testing the liquid sample or sealing the liquid sample for subsequent testing. The instructions may further include instructions for using an electronic reader to read the optical label.

[0070] The instructions may include instructions for collecting a pathogen from a pathogen sample. The kit may include a pathogen test device and instructions for testing the pathogen sample. The pathogen test device may be a liquid assay device. The liquid assay device may be, for example, a vertical flow assay device or a horizontal flow assay device. In one embodiment, the instructions include steps for testing for a virus in the pathogen sample.

[0071] All references and publications mentioned in this specification are hereby expressly incorporated by reference in their entirety into this disclosure, except where they may directly conflict with this disclosure. Although specific embodiments have been illustrated and described herein, it will be understood by those skilled in the art that the specific embodiments illustrated and described may be replaced by various alternative implementations and / or equivalent implementations without departing from the scope of this disclosure. It is to be understood that this disclosure is not unduly limited by the exemplary embodiments and examples described herein, and that such embodiments and examples are merely illustrative within the scope of this disclosure, which is intended to be limited only by the claims set forth herein.

Claims

**Claim 1** A liquid container that defines a container volume and has an opening, wherein the container volume is less than 20 mL, and a liquid container; A certain volume of liquid eluent that is within the container volume and defines a liquid surface; An air flow conduit that extends from an exhalation inlet end to a distal end, and the air flow conduit extends through the opening, and; The distal end of the air flow conduit is disposed within the certain volume of liquid eluent or above the liquid surface, and the opening includes an air outlet, A pathogen sample collection device. **Claim 2** A liquid container that defines a container volume and has an opening, and; A certain volume of liquid eluent that is within the container volume and defines a liquid surface; An air flow conduit that extends from an exhalation inlet end to a distal end, and is configured to allow only a unidirectional flow exiting from the distal end of the air flow conduit, and the air flow conduit extends through the opening, and; The distal end of the air flow conduit is disposed within the certain volume of liquid eluent or above the liquid surface, and the opening includes an air outlet, A pathogen sample collection device. **Claim 3** The pathogen sample collection device according to claim 1, wherein the air flow conduit is configured to allow only a unidirectional flow exiting from the distal end of the air flow conduit. **Claim 4** The pathogen sample collection device according to any one of claims 1 to 3, wherein the container volume is less than 15 mL or in the range of 5 mL to 10 mL. **Claim 5** The pathogen sample collection device according to any one of claims 1 to 4, wherein the volume of the liquid eluent is less than 5 mL or in the range of 1 mL to 5 mL. **Claim 6** The pathogen sample collection device according to any one of claims 1 to 5, wherein the air flow conduit is disposed within the certain volume of liquid eluent. **Claim 7** The pathogen sample collection device according to any one of claims 1 to 6, wherein the distal end of the air flow conduit is above the liquid surface. **Claim 8** The pathogen sample collection device according to any one of claims 1 to 7, wherein the air flow conduit has a first opening diameter at the exhalation inlet end and a second opening diameter at the distal end, and the second opening diameter is smaller than the first opening diameter. **Claim 9** The pathogen sample collection device according to any one of claims 1 to 8, wherein the air flow conduit includes a one-way flow valve. **Claim 10** The pathogen sample collection device according to any one of claims 1 to 9, further comprising a lid configured to fit with the opening.

11. The pathogen sample collection device according to claim 10, wherein the air conduit extends through the lid.

12. The pathogen sample collection device according to claim 10 or 11, wherein the lid has an air outlet.

13. The pathogen sample collection device according to any one of claims 10 to 12, wherein the lid engages with the opening by snap fit.

14. The pathogen sample collection device according to any one of claims 10 to 13, wherein the lid has a coupling mechanism for fitting with a complementary coupling mechanism at the opening of the liquid container.

15. The pathogen sample collection device according to claim 14, wherein the coupling mechanism has a threaded coupling mechanism, and the complementary coupling mechanism is a threaded coupling mechanism.

16. The pathogen sample collection device according to claim 14, wherein the coupling mechanism has an angled coupling surface.

17. The pathogen sample collection device according to claim 14, wherein the coupling mechanism has a frustoconical portion and a plurality of ribs extending from the frustoconical portion.

18. The pathogen sample collection device according to claim 17, wherein the plurality of ribs includes radial ribs.

19. The pathogen sample collection device according to claim 17, wherein the plurality of ribs has a first rib having a first diameter adjacent to a first end and a second rib having a second diameter larger than the first diameter.

20. The pathogen sample collection device according to any one of claims 1 to 19, wherein the liquid eluent is physiological saline.

21. The pathogen sample collection device according to any one of claims 1 to 20, wherein the liquid eluent is physiological saline containing a surfactant.

22. The pathogen sample collection device according to any one of claims 1 to 21, further comprising an air porous layer disposed between the liquid surface and the opening of the liquid container, and the air porous layer extends substantially along the entire inner diameter of the liquid container.

23. The pathogen sample collection device according to claim 21, wherein the air porous layer does not absorb the liquid eluent.

24. A method of obtaining a pathogen sample using a sample collection device, wherein the sample collection device is A liquid container that defines a container volume and has an opening, a certain volume of liquid eluent that is within the container volume and defines a liquid surface, and an air flow conduit that extends from an exhalation inlet end to a distal end, wherein the distal end of the air flow conduit is disposed within the certain volume of liquid eluent or above the liquid surface. The method is A step of sucking at the exhalation inlet end to form a jet of exhaled air flow exiting from the distal end of the air flow conduit, wherein the jet of exhaled air flow contacts the certain volume of liquid eluent and captures a sample from the jet of exhaled air flow within the certain volume of liquid eluent to form a liquid sample, including the sucking step. Method.

25. The method according to claim 24, wherein the air flow conduit is configured to allow only a unidirectional flow exiting from the distal end of the air flow conduit.

26. The method according to claim 24, wherein the jet of exhaled air flow hits the liquid surface.

27. The method according to claim 24, wherein the jet of exhaled air flow enters the certain volume of liquid eluent below the liquid surface.

28. The method according to any one of claims 24 to 27, further including a step of removing the air flow conduit from the opening after the sucking step.

29. The method according to any one of claims 24 to 28, further including a step of sealing the opening to form a sealed sample.

30. The method according to any one of claims 24 to 28, further including a step of attaching a dropper cap to the opening and a step of dispensing the sample from the dropper cap.

31. The method according to any one of claims 24 to 30, wherein the container volume is less than 15 mL or in the range of 5 mL to 10 mL.

32. The method according to any one of claims 24 to 31, wherein the volume of the liquid eluent is less than 5 mL or in the range of 1 mL to 5 mL.

33. The method according to any one of claims 24 to 32, further including a step of testing the liquid sample for pathogens.

34. The method according to any one of claims 24 to 32, further including a step of testing the liquid sample for viruses.

35. A kit for collecting a pathogen sample from respiration, The pathogen sample collection device according to any one of claims 1 to 23, Instructions for collecting a pathogen sample, and A kit comprising

36. The kit according to claim 35, further comprising a sealing cap configured to seal the opening to form a sealed sample.

37. The kit according to claim 35 or 36, further comprising a dropper cap configured to fit with the opening and dispense the pathogen sample.

38. The kit according to any one of claims 35 to 37, wherein the instructions include instructions for collecting a pathogen from the pathogen sample.

39. The kit according to claim 35 or 38, further comprising a pathogen test device and instructions for testing a pathogen sample.

40. The kit according to claim 30, wherein the instructions include testing for a virus in the pathogen sample.

Images