Sample collection system and eluent delivery element therefor - Patents.com

Abstract

According to one embodiment, a sample collection system includes a sample collection device and an elution fluid delivery element. The sample collection device includes a housing including an airflow path extending from a proximal end including an air inlet to a distal end, a piercing element disposed within the airflow path, and a sample collector including a porous sample collection medium disposed to occlude the airflow path. The elution fluid delivery element includes a reservoir containing elution fluid and a membrane disposed at a mating end of the reservoir and sealing the reservoir, the mating end constructed to mate with the proximal end of the airflow path such that the piercing element pierces the membrane.

Description

[Technical field]

[0001] The present disclosure relates to sample collection devices and systems.The present disclosure relates to bioaerosol collection devices and systems.The present disclosure further relates to eluent delivery elements for sample collection devices and systems. [Background technology]

[0002] Diagnostic tests used to test for the presence of viruses or other pathogens in the respiratory tract, throat, or nasopharynx typically involve the insertion of a swab into the back of the nose, the middle turbinate area of ​​the nose, 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.

[0003] Recently, an unprecedented need for rapid viral testing has arisen due to the COVID-19 pandemic. Attempts to control the pandemic will require a large-scale expansion of testing for the SARS-CoV-2 virus in several different clinical and epidemiological settings. Until recently, nasopharyngeal (NP) swabs were the preferred specimen type of the Centers for Disease Control and Prevention (CDC) because these specimens were thought to provide the most robust detection of infection in patients. However, there are conflicting reports regarding which of several specimen types has the highest viral load.

[0004] However, sensitivity is a complex issue, as detection in the upper respiratory tract (nasopharynx and oropharynx) is affected by multiple factors, including duration of illness prior to testing, as well as the limit of detection (LoD) of the RT-PCR assay used. Availability of NP swabs and resources to establish NP collection sites with sample collection personnel remain significant bottlenecks. To address these issues, healthcare systems have adopted multiple different strategies, including engaging industrial manufacturers to mass-produce novel 3D printed NP swabs, as well as evaluating different specimen types and alternative sample collection strategies, such as saliva.

[0005] The evaluation of nasal swabs and saliva is a rapidly growing area of ​​interest, especially as these specimen sample types involve less invasive procedures than NP swabs. Thus, such samples can be self-collected by patients with a simple set of instructions, alleviating the need for highly trained medical personnel for specimen collection and reducing the use of personal protective equipment (PPE), which is in short supply.

[0006] Many of the U.S. Food and Drug Administration Emergency Use Authorization (FDA EUA) RT-PCR assays have been approved for use with nasal swabs as well as saliva as a sample type, but it remains unclear how well these samples perform compared to NP swabs. To date, nasal swab testing has shown conflicting results, with some researchers reporting similar test performance to NP swabs and others finding reduced sensitivity.

[0007] Currently available at-home viral tests (e.g., COVID-19 tests) involve nasal swabs and test kits (e.g., Ellume™ test, Abbot™ BinaxNOW™ test, and Lucira™ All-in-One Test Kit). Tests that utilize nasal swab samples or saliva compete with contaminants that can interfere with various diagnostic tests. As a result, these sample types require a purification step when using RT-PCR molecular tests.

[0008] There is a need for simpler and cleaner sample collection systems, and easy elution of samples in an easy-to-use procedure. Additionally, there is a need for sample collection systems that can also capture and elute samples that have low SARS-CoV-2 viral loads, but are still capable of transmitting the virus to others. Also, a more accurate system is needed to reduce human error and provide more reproducible and reliable test results. Summary of the Invention

[0009] There is a need for an inexpensive, easy to use, and reliable sample collection system that can be used by the layperson to obtain samples for testing for the presence of a target virus, target pathogen, or other target analyte in the collected sample. There is a need for an inexpensive, easy to use, and reliable eluent delivery element that can be used by a layperson to transfer the sample collected from the sample collection device to an assay. The sample collection system of the present disclosure includes a sample collection device for collecting a sample from the exhaled airstream onto a sample collection medium, and an eluent delivery element for eluting the sample onto an assay, such as a lateral flow assay, that can be used to analyze the sample.

[0010] It is desirable to provide sample collection devices and systems that are easy to use, which may advantageously be self-contained and optionally sterile. Self-contained (and optionally sterile) devices and systems may improve the accuracy and reliability of pathogen testing due to reduced contamination and background noise, unlike swabs and other test collection devices that may be contaminated during use and / or testing.

[0011] It would be further desirable to provide a system that provides easy elution of collected samples and transfer onto an assay for safe and contamination-free testing after sample collection. It would be further desirable to provide a system that provides a quantitative amount of eluent for easy elution of collected samples and transfer onto an assay. Quantitativeness can improve the accuracy of the analysis. According to embodiments disclosed herein, such a system is provided.

[0012] According to one embodiment, a sample collection system includes a sample collection device and an elution fluid delivery element. The sample collection device includes a housing with an airflow path extending from a proximal end with an air inlet to a distal end, a piercing element disposed within the airflow path, and a sample collector with a porous sample collection medium disposed to occlude the airflow path. The elution fluid delivery element includes a reservoir containing elution fluid and a membrane disposed at a mating end of the reservoir and sealing the reservoir, the mating end constructed to mate with a proximal end of the airflow path such that the piercing element pierces the membrane.

[0013] The sample collection system has a non-binding position and a binding position in which an eluent delivery element is coupled to the sample collection device. The eluent delivery element is constructed to deliver eluent from a reservoir onto the porous sample collection medium in the binding position. The eluent delivery element can be constructed to deliver a measured amount of eluent from the reservoir onto the porous sample collection medium in the binding position.

[0014] The sample collection system may further include a lateral flow assay, which may be disposed adjacent to the porous sample collection medium.

[0015] The housing may include a mouthpiece defining a proximal end of the airflow pathway. The piercing element may be recessed within the mouthpiece.

[0016] The housing may include a support element in the airflow path and may further include a protrusion extending from the support element in a direction opposite the piercing element. The protrusion may define a fluid flow guide extending distally from the sample collector. The fluid flow guide may be a distal section of the piercing element. The distal section may be in direct contact with a sample receiving area of ​​a lateral flow assay. The protrusion may deform the porous sample collection medium into a conical shape. The protrusion may bring the porous sample collection medium into direct contact with a sample receiving area of ​​the assay.

[0017] The porous sample collection medium may be made of a non-woven material. The non-woven material may comprise polylactic acid, polypropylene, or a combination thereof. The porous sample collection medium may carry a static charge.

[0018] According to one embodiment, the kit includes a sample collection device, an elution fluid delivery element, and an assay. The sample collection device includes a housing with an airflow path having a length extending from a proximal end with an air inlet to a distal end, a sample collector with a porous sample collection medium arranged to occlude the airflow path, and a piercing element arranged in the airflow path and extending from the sample collector along the length of the airflow path. The elution fluid delivery element includes a reservoir containing elution fluid and a membrane arranged at a mating end of the reservoir and sealing the reservoir, the mating end being constructed to mate with a proximal end of the airflow path such that the piercing element pierces the membrane. The assay is configured or configurable to receive a sample from the sample collection element.

[0019] According to one embodiment, a method of obtaining a sample using a sample collection system includes blowing into a proximal end of an airflow pathway to collect a sample on a porous sample collection medium, coupling a coupling end of an elution fluid delivery element to a first end of the airflow pathway, and transferring a measured amount of elution fluid from a reservoir onto the porous sample collection medium to elute the collected sample from the porous sample collection medium. The method may further include depositing the elution fluid containing the collected sample onto a lateral flow assay. [Brief description of the drawings]

[0020] [Figure 1A] FIG. 1 is a perspective view of a sample collection system, according to one embodiment. [Figure 1B] FIG. 1B is a cross-sectional perspective view of the sample collection system of FIG. 1A. [Diagram 2] 1B is a schematic perspective view of a piercing element and a sample collector of the system of FIG. 1A, according to one embodiment. [Figure 3A] FIG. 1B is a schematic diagram of the insertion of an eluent delivery element into the mouthpiece of the device of FIG. 1A, according to one embodiment. [Figure 3B] FIG. 1B is a schematic diagram of the insertion of an eluent delivery element into the mouthpiece of the device of FIG. 1A, according to one embodiment. [Figure 3C] FIG. 1B is a schematic diagram of the insertion of an eluent delivery element into the mouthpiece of the device of FIG. 1A, according to one embodiment. [Figure 4] 1B is a schematic cross-sectional view of the mouthpiece and eluent delivery element of the system of FIG. 1A in a docking position, according to one embodiment. [Figure 5A] FIG. 1B is a cross-sectional view of a hollow needle piercing element for the system of FIG. 1A, according to one embodiment. [Figure 5B] FIG. 1B is a cross-sectional view of a blade-shaped piercing element for the system of FIG. 1A, according to one embodiment. [Figure 5C] FIG. 1B is a schematic perspective view of an arrowhead-shaped piercing element and mouthpiece for the system of FIG. 1A, according to one embodiment. [Figure 6]FIG. 1B is a schematic cross-sectional side view of the system of FIG. 1A having an alternative piercing element, according to one embodiment. [Figure 7] FIG. 1B is a schematic cross-sectional side view of the system of FIG. 1A having an alternative piercing element, according to one embodiment. [Figure 8] FIG. 1B is a schematic cross-sectional side view of the system of FIG. 1A having an alternative piercing element, according to one embodiment. [Figure 9] 1 is a schematic cross-sectional view of a sample collection system having an alternative piercing element, according to one embodiment. [Figure 10A] FIG. 1B is a schematic perspective view of an eluent delivery element of the system of FIG. 1A, according to one embodiment. [Figure 10B] FIG. 10B is a schematic bottom view of the elution fluid delivery element of FIG. 10A, according to one embodiment. [Figure 11] 1B is a schematic cross-sectional side view of a mouthpiece for the system of FIG. 1A, according to one embodiment. [Figure 12A] FIG. 1B is a side view of a mouthpiece for the system of FIG. 1A, according to one embodiment. [Figure 12B] FIG. 12B is another side view of the mouthpiece of FIG. 12A. [Figure 12C] FIG. 12B is a side cross-sectional view of the mouthpiece of FIG. 12A. [Figure 12D] FIG. 12B is a top view of the mouthpiece of FIG. 12A. [Figure 13A] FIG. 12B is a side view of the inlet portion of the mouthpiece of FIG. 12A. [Figure 13B] FIG. 13B is a side cross-sectional view of the inlet portion of FIG. 13A. [Figure 13C] FIG. 13B is a top view of the inlet portion of FIG. 13A. [Figure 13D] FIG. 13B is a perspective view of the inlet portion of FIG. 13A. [Figure 14A] FIG. 12B is a side view of the base of the mouthpiece of FIG. 12A. [Figure 14B] FIG. 14B is a side cross-sectional view of the base of FIG. 14A. [Figure 14C] FIG. 14B is a top view of the base of FIG. 14A. [Figure 14D] FIG. 14B is a bottom view of the base of FIG. 14A. [Figure 14E]FIG. 14B is a perspective view of the base of FIG. 14A. [Figure 15A] FIG. 1B is a side view of a mouthpiece for the system of FIG. 1A, according to one embodiment. [Figure 15B] FIG. 15B is another side view of the mouthpiece of FIG. 15A. [Figure 15C] FIG. 15B is a side cross-sectional view of the mouthpiece of FIG. 15A. [Figure 15D] FIG. 15B is a top view of the mouthpiece of FIG. 15A. [Figure 16A] FIG. 15B is a side view of the inlet portion of the mouthpiece of FIG. 15A. [Figure 16B] FIG. 16B is a side cross-sectional view of the inlet portion of FIG. 16A. [Figure 16C] FIG. 16B is a top view of the inlet portion of FIG. 16A. [Figure 16D] FIG. 16B is a perspective view of the inlet portion of FIG. 16A. [Figure 17A] FIG. 1B is a side view of a mouthpiece for the system of FIG. 1A according to an alternative embodiment. [Figure 17B] FIG. 17B is a side cross-sectional view of the mouthpiece of FIG. 17A. [Figure 17C] FIG. 17B is a top view of the mouthpiece of FIG. 17A. [Figure 17D] FIG. 17B is a perspective view of the mouthpiece of FIG. 17A. [Figure 17E] FIG. 17B is another perspective view of the mouthpiece of FIG. 17A. [Figure 18A] FIG. 1B is a side cross-sectional view of a mouthpiece for the system of FIG. 1A according to an alternative embodiment. [Figure 18B] FIG. 18B is a cross-sectional top view of an eluent delivery element for use with the mouthpiece of FIG. 18A. [Figure 18C] FIG. 18C is a side cross-sectional view of the elution fluid delivery element of FIG. 18B. definition

[0021] All scientific and technical terms used herein have the meanings commonly used in the art unless otherwise specified. The definitions provided herein are intended to aid in the understanding of certain terms used frequently herein and are not intended to limit the scope of the present disclosure.

[0022] Unless otherwise indicated, the terms "polymer" and "polymeric material" include, but are not limited to, organic homopolymers, copolymers (e.g., block copolymers, graft copolymers, random copolymers, alternating copolymers, etc.), terpolymers, and the like, as well as blends and modifications thereof. Furthermore, unless otherwise specifically limited, the term "polymer" is intended to encompass all possible geometric configurations of the material. These configurations include, but are not limited to, isotactic, syndiotactic, and atactic symmetries.

[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 inlet or mouthpiece element, and the most downstream element of the device is the outlet or sample receiving area of ​​the assay.

[0024] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of the text that follows the heading, unless specifically stated.

[0025] The term "ie" is used herein as an abbreviation of the Latin phrase id est, meaning "that is," and "eg" is used herein as an abbreviation of the Latin phrase exempli gratia, meaning "for example."

[0026] 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.

[0027] The term "about" is used herein in conjunction with numerical values ​​to include normal variations in measurements expected by one of ordinary skill in the art, and can be understood to have the same meaning as "approximately" and to cover typical margins of error, such as ±5% of the stated value. Additionally, unless otherwise indicated, all numbers expressing quantities and all terms expressing direction / orientation (e.g., vertical, horizontal, parallel, perpendicular, etc.) used in this specification and claims are to be understood as being modified in all instances by the term "approximately."

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] The term "substantially" as used herein can be understood to have the same meaning as "significantly" and to modify the following term by at least about 90%, at least about 95%, or at least about 98%. The term "not substantially" as used herein can be understood to have the same meaning as "not significantly" and to have the opposite meaning of "substantially", i.e., to modify the following term by no more than 10%, no more than 5%, or no more than 2%.

[0034] 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.

[0035] Any directions referred to herein, such as "front," "rear," "top," "bottom," "left," "right," "upper," "lower," and other directions and orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system or the use of the device or system. A device or system as described herein can be used in several directions and orientations.

[0036] Any directions referred to herein, such as "top," "bottom," "left," "right," "upper," "lower," and other directions and orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system or the use of the device or system. A device or system as described herein can be used in several directions and orientations. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] FIELD OF THE DISCLOSURE The present disclosure relates to sample collection devices and systems.

[0038] The sample collection device includes a sample collector that includes a porous sample collection medium along an airflow path formed by the device housing. The porous sample collection medium is constructed to capture viruses, pathogens, or other analytes carried in the exhaled airflow. The porous sample collection medium may be a non-woven material that can capture pathogens, viruses, or other analytes. After loading the sample onto the porous sample collection medium, the sample can be eluted from the sample collection medium onto an assay. The sample can be analyzed for the presence of pathogens or other analytes of interest. According to one embodiment, the sample may be eluted by passing a liquid (e.g., an eluent) through the porous sample collection medium to elute the sample containing the pathogens, viruses, or other analytes bound to the porous sample collection medium to form an eluate, and flowing the eluate over the assay. The eluate can then be analyzed using the assay.

[0039] According to one embodiment, the sample collection system includes a sample collection device and an elution fluid delivery element. The sample collection device includes a housing having an airflow path extending from a proximal end to a distal end. The proximal end forms an air inlet. The distal end may be at or adjacent to a sample receiving area of ​​the assay. The piercing element is disposed within the airflow path. The sample collection device further includes a sample collector including a porous sample collection medium disposed to occlude the airflow path. The elution fluid delivery element includes a reservoir containing elution fluid and a membrane disposed at a mating end of the reservoir to seal the reservoir. The mating end is constructed to mate with a proximal end (e.g., an inlet end) of the airflow path such that the piercing element pierces the membrane and releases the elution fluid from the reservoir.

[0040] According to one embodiment, a user can breathe into the sample collection device to load the sample collector with a sample of the exhaled airstream to form a loaded porous sample collection medium. The user can breathe through an air inlet of the sample collection device. The air inlet may be formed as a mouthpiece. Alternatively, the sample collection device may have a nosepiece constructed for breathing through the nose (e.g., through one or both nostrils). The user can breathe through the air inlet of the mouthpiece or nosepiece of the sample collection device. The housing is constructed such that breathing through the air inlet causes the exhaled airstream to pass through the porous sample collection medium. The porous sample collection medium is constructed to capture viruses, other pathogens, or other analytes from the exhaled airstream. The user can then connect an elution fluid delivery element to the mouthpiece of the device to apply an elution fluid to the loaded porous sample collection medium to elute the loaded sample onto the assay.

[0041] The sample collection system may include a lateral flow assay adjacent to the porous sample collection medium. In some embodiments, the porous sample collection medium is in direct contact with the lateral flow assay. In other embodiments, the porous sample collection medium is not in direct contact with the lateral flow assay.

[0042] The housing may include an inlet portion or mouthpiece that defines a proximal end of the airflow path. The piercing element may be recessed into the inlet portion or mouthpiece. The piercing element is constructed to pierce, puncture, score, cut, slit, or otherwise rupture the membrane of the elution fluid delivery reservoir to form an opening in the membrane. These piercing features are collectively referred to herein as "piercing". The piercing element may remain inside the elution fluid delivery reservoir or may break during or after piercing. Perforation of the membrane may be assisted by rotating the elution fluid delivery element as it is inserted into the airflow path, forming an opening in the membrane that is larger than the size of the piercing element. The piercing element may further be constructed to act as a fluid guide. The piercing element may be constructed to draw fluid from the reservoir. The piercing element may be constructed to guide the flow of elution fluid onto the porous sample collection medium and, optionally, onto a sample receiving area on the assay.

[0043] The piercing element may be recessed into the mouthpiece by any suitable distance that allows the elution fluid delivery reservoir to be pierced, but reduces or minimizes the possibility of a user inadvertently contacting the piercing tip. A suitable recessed distance may be determined based on the particular dimensions of the mouthpiece and the elution fluid delivery element. The piercing element may be recessed by a distance of, for example, 4 mm or more, 5 mm or more, or 6 mm or more. The piercing element may be recessed by a distance of 10 mm or less, 9 mm or less, or 8 mm or less. In some embodiments, the piercing element is recessed by 4 mm to 10 mm or 5 mm to 8 mm.

[0044] 1A and 1B, an exemplary embodiment of a sample collection system 1 having a sample collection device 10 and an eluent delivery element 20 is shown. The sample collection device 10 includes a housing 11 that houses an assay 30 (e.g., a lateral flow assay). A mouthpiece 230 extends from the housing 11 to form an airflow path 210. A sample collector 250 including a porous sample collection medium 252 occludes the airflow path 210. The mouthpiece 230 is constructed to receive the eluent delivery element 20. A piercing element 220 is disposed within the airflow path 210 and configured to pierce the eluent delivery element 20.

[0045] The structure of the sample collection device 10 is not particularly limited, so long as the sample collection device 10 facilitates the sample collector 250, airflow path 210, piercing element 220, eluent delivery element 20, and assay 30. The housing of a suitable sample collection device may be modified to include a mouthpiece 230, 430, 530, 530' having the airflow path, sample collector, and piercing element of the present disclosure. Examples of such sample collection devices that can be modified include those described in U.S. Provisional Patent Applications Nos. 63 / 200058 (filed February 12, 2021), 63 / 202140 (filed May 28, 2021), 63 / 200958 (filed April 6, 2021), 63 / 202143 (filed May 28, 2021), 63 / 201983 (filed May 21, 2021), 63 / 203441 (filed July 22, 2021), and 63 / 203442 (filed July 22, 2021).

[0046] The housing 11 of the sample collection device can be constructed from one or more parts or portions. In some embodiments, as shown in Figures 1A and 1B, the housing 11 includes a first part 100 that carries the assay 30 (e.g., a lateral flow assay) and a second part 200 that houses the first part 100 and the assay 30 and provides or connects with an airflow path 210 and a sample collector 250. The mouthpiece 230 may be a separate part that is coupled to the housing 11 or may be integrally formed with the housing 11 as shown. The housing 11 can include an observation window 270 that allows a user to view the results of the assay 30.

[0047] The mouthpiece 230 can define a proximal end 211 that includes an air inlet 231 for the airflow pathway 210. The mouthpiece 230 can include a support element 240 or a support grid. The piercing element 220 extends proximally (towards the air inlet 231) from the support element 240 or the support grid. The piercing element 220 can be recessed a distance D220 into the mouthpiece 230. The piercing element 220 can be recessed a sufficient distance to reduce or minimize the possibility of a user inadvertently contacting the piercing tip 221 of the piercing element 220. The piercing element 220 is constructed to pierce, puncture, score, cut, slit, or otherwise rupture the membrane 23 of the elution fluid delivery element 20. The piercing element 220 can further be constructed to function as a fluid guide. The piercing element 220 can be constructed to draw fluid from the reservoir 21. The piercing element 220 may be constructed to direct the flow of elution fluid 22 onto the porous sample collection medium 252 and, optionally, onto a sample receiving area 31 on the assay 30 .

[0048] FIG. 2 shows a schematic diagram of the piercing element 220, the support element 240 or support grid, and the sample collector 250. The piercing element 220 may have a shaft 222 extending proximally from the support element 240 or support grid. The piercing element 220 may also extend distally (towards the assay 30) from the support element 240 and include a distal section 225. The support element 240 or support grid may serve multiple purposes, including supporting the piercing element 220 in the airflow path 210, but optionally also supporting the porous sample collection medium 252. That is, the support element 240 or support grid may form part of the sample collector 250. In some embodiments, the support element 240 or support grid may support either the porous sample collection medium 252, the piercing element 220, or both the porous sample collection medium 252 and the piercing element 220. In some embodiments, the sample collector 250 includes a separate medium support element 251. The porous sample collection medium 252 may be disposed adjacent to the support element 240 or the media support element 251 (if provided), or may be disposed between the support element 240 and the media support element 251. In some embodiments, such as those shown in FIGS. 12A-16D, the support element 240 may be disposed at an inlet portion 510 of the mouthpiece 530, and the media support element 251 may be disposed at a base 550 of the mouthpiece 530. The support element 240 or support grid may have any suitable structure. For example, the support element 240 or support grid may have a wheel-and-spoke design, a mesh, or any other suitable configuration. In some embodiments, the support element 240 or support grid may be tapered or angled toward the center of the airflow channel and toward the assay to promote fluid flow to the assay, as shown in FIGS. 15C, 15D, and 16B.

[0049] According to one embodiment, a user can breathe into the mouthpiece 230 of the sample collection device 10 to load a sample of the exhaled airflow onto the porous sample collection medium 252 of the sample collector 250. The user may breathe through the air inlet 231 of the mouthpiece 230. The exhaled airflow passes along the airflow path 210 through the porous sample collection medium 252.

[0050] After loading a sample into the sample collector 250 (e.g., the porous sample collection medium 252), a user may connect the eluent delivery element 20 with the sample collection device 10 and apply eluent 22 to the loaded medium. The coupling of the eluent delivery element 20 with the sample collection device 10 is shown diagrammatically in Figs. 3A-3C. The sample collection system 1 has a non-coupling position P1 (Fig. 3A) and a coupling position P2 (Fig. 3C). In the coupling position P2, the eluent delivery element is coupled with the mouthpiece 230 of the sample collection device 10 and delivers eluent from a reservoir onto the porous sample collection medium 252. The eluent delivery element 20 can be coupled with the sample collection device 10 by inserting the coupling end 24 of the eluent delivery element 20 into the air inlet 231 and the internal cavity 232 of the mouthpiece 230. The eluent delivery element 20 may be pushed, twisted, or snapped into place. The sample collection system 1 may have an indicator configured to indicate whether the sample collection system is in the binding position P2. The indicator may be, for example, an audible indicator (e.g., a "click" sound) or a visual indicator (e.g., corresponding alignment features on the eluent delivery element and the sample collection device). When the eluent delivery element 20 is in the binding position P2, the central longitudinal axis A20 of the eluent delivery element 20 may be coaxial with the central longitudinal axis A230 of the mouthpiece 230.

[0051] According to one embodiment, the eluent delivery element 20 is constructed to deliver a measured amount of eluent 22 from the reservoir 21 onto the porous sample collection medium 252 at the binding location P2.

[0052] The sample collection system 1 can be constructed such that after the elution fluid delivery element 20 is inserted and pierced, the elution fluid delivery element 20 is partially retracted axially to facilitate flow of elution fluid from the reservoir 21. The elution fluid delivery element 20 can have a piercing position, e.g., a binding position P2, and a fluid delivery position, the fluid delivery position being axially proximal (along the longitudinal axis A230 of the mouthpiece 230) to the piercing position P2.

[0053] 4 shows a cross-sectional schematic view of the elution fluid delivery element 20 at a coupling position P2 with the mouthpiece 230. At the coupling position P2, the piercing element 220 extends into the reservoir 21.

[0054] The piercing element 220 may have any suitable shape. Various shapes are shown in Figures 5A-5C. The piercing element 220 includes a tip 221 and a shaft 222. In some embodiments, the piercing element 220 is shaped like a needle 227 or a blade 223. The needle 227 shaped piercing element 220 may optionally have a hollow center 228, as shown in cross section in Figure 5A. The piercing element 220 may have a non-circular cross-sectional shape along its central longitudinal axis, such as the cross-sectional shape of the blade 223 shown in Figure 5B. The cross-sectional shape or size of the piercing element 220 may vary along the length of the piercing element. That is, the piercing element 220 may have a first cross-sectional shape and a second cross-sectional shape along the central longitudinal axis A220, where the second cross-sectional shape is different from the first cross-sectional shape. The piercing element 220 may have a first cross-sectional diameter and a second cross-sectional diameter along the central longitudinal axis, the second cross-sectional diameter being different from the first cross-sectional diameter. For example, the cross-sectional shape or size, or both, may be different at the tip 221 of the piercing element 220 than along the shaft 222. One example of a piercing element 220 having a tip 221' with a different cross-sectional shape and size than the shaft 222 is the piercing element 220' with an arrowhead tip 229 shown in FIG. 5C. The arrowhead tip 229 may have a maximum cross-sectional dimension at the base of the tip 229 that is larger than the cross-sectional dimension of the shaft. Having a tip 221, 229 with a larger cross-sectional dimension than the shaft 222 can help drain the reservoir even if the piercing element remains within the pierced opening in the membrane.

[0055] The mouthpiece 230 (and airflow path 210) can define a central longitudinal axis A230. In some embodiments, the piercing element 220 extends parallel to the central longitudinal axis A230. In some embodiments, the piercing element 220 is not coaxial with the mouthpiece 230 and airflow path 210. In some embodiments, the piercing element 220 is coaxial with the mouthpiece 230 and airflow path 210.

[0056] The piercing element 220 may be constructed to act as a fluid guide and may include features that aid in drawing fluid from the reservoir 21 or direct the flow of the eluent 22 onto the porous sample collection medium 252 and, optionally, onto the sample receiving area 31 on the assay 30. In some embodiments, the piercing element 220 is a hollow needle 227 having a hollow center 228 that extends from an open first end to an opposite open second end. The piercing element 220 may have a surface texture, a surface treatment, or a material configured to promote wicking or capillary flow. For example, the piercing element 220 may have a surface texture, a surface treatment, or a material that aids in drawing fluid from the reservoir 21 or flowing fluid toward the porous sample collection medium 252, or both. Examples of materials that may promote wicking or capillary flow include porous materials, such as cellulosic materials, and hydrophilic materials, such as hydrophilic polymers. Examples of surface textures that can promote wicking or capillary flow include angled channels (e.g., channels with a V-shaped cross section), microchannels, capillary channels, and surface roughness. Examples of surface treatments that can promote eluent flow include corona treatments to make the surface easily wettable.

[0057] In some embodiments, the piercing element 220 includes a proximal section 224 (e.g., the section that operatively forms the piercing element 220) that extends proximally from the support element 240, and a distal section 225 that extends distally from the support element 240. Examples of such embodiments are shown in Figures 6-9.

[0058] The distal section 225 may be in direct contact with the sample receiving area 31 of the lateral flow assay 30, as shown in Figure 6. That is, the distal end 226 contacts the sample receiving area 31 of the lateral flow assay 30. In some embodiments, the distal section 225' is not in direct contact with the sample receiving area 31, as shown in Figure 7.

[0059] The distal section 225 (or the entire piercing element 220 including the proximal section 224 and the distal section 225) may have a surface texture, a surface treatment, or a material configured to promote wicking or capillary flow. Examples of materials that can promote wicking or capillary flow include porous materials such as cellulosic materials, and hydrophilic materials such as hydrophilic polymers. Examples of surface textures that can promote wicking or capillary flow include angled channels (e.g., channels with a V-shaped cross section), microchannels, capillary channels, and surface roughness. Examples of surface treatments that can promote eluent flow include corona treatments to make the surface easily wettable.

[0060] 8 and 9, the porous sample collection medium 252 is disposed beneath the distal section 225 of the piercing element 220, which extends from the support grid or element 240 toward the assay 30 and forces or deforms the porous sample collection medium 252 into a non-planar shape, such as a cone or cup shape. The distal section 225 of the piercing element 220 may bring the porous sample collection medium 252 into direct contact with the sample receiving area 31 of the assay 30.

[0061] The sample collection device 10 and the elution fluid delivery element 20 can be coupled by a bayonet coupling, an interference fit, a snap fit, or a threaded coupling. The elution fluid delivery element 20 may be constructed to be rotatably inserted into the airflow path 210 (e.g., into the mouthpiece 230). Rotating the elution fluid delivery element 20 as it is inserted into the airflow path 210 can assist in piercing the membrane 23, forming an opening in the membrane 23 that is larger than the size of the piercing element 220.

[0062] According to one embodiment, the mouthpiece 230 and the eluent delivery element 20 include coupling elements for guiding the movement of the eluent delivery element 20 when the eluent delivery element 20 is received in the internal cavity 232 of the mouthpiece 230. The reservoir 21 may have a cylindrical body, and the mouthpiece 230 may have a cylindrical internal cavity 232. The eluent delivery element 20 (e.g., the reservoir 21) is constructed to be at least partially received in the internal cavity 232. The eluent delivery element 20 may include one or more coupling elements 25 (e.g., alignment pins). For example, the eluent delivery element 20 may have two coupling elements 25 (e.g., alignment pins) formed by protrusions extending from both sides of the reservoir 21, as shown in Figures 10A and 10B. The inner wall 233 of the mouthpiece 230 may include a corresponding receiving element 235 (e.g., a groove) constructed to receive the coupling element 25 (e.g., an alignment pin), as shown in Figure 11. The receiving element 235 may be curved to facilitate a bayonet fit, as shown, or may be straight (parallel to the longitudinal axis A230).

[0063] In some embodiments, the mouthpiece may be constructed from two or more pieces to facilitate assembly of the mouthpiece and insertion of the porous sample collection medium. An example of a two-piece mouthpiece is shown in Figures 12A-16D.

[0064] 12A-12D, the mouthpiece 530 can include an inlet portion 510 coupled to a base 550. The inlet portion 510 defines an air inlet 531 and an opposite distal end 512. The distal end 512 of the inlet portion 510 couples to an inlet receiving end 551 of the base 550. The distal end 552 of the base 550 couples to a housing 11 of the sample collection device such that the airflow path 532 is aligned with the sample receiving area 31 of the assay 30. Any suitable coupling mechanism (e.g., snap fit, bayonet, interference fit, threads, etc.) can be used to couple the base 550 to the housing 11 and the inlet portion 510 to the base 550.

[0065] The sample collection medium 252 can be disposed between the inlet portion 510 and the base 550. The base 550 can form a ledge 562, and the distal end 512 of the inlet portion 510 can abut the ledge 562. The sample collection medium 252 can be disposed between the ledge 562 and the distal end 512 of the inlet portion 510. The base 550 and the inlet portion 510 can mate together using a snap-fit ​​connection that sandwiches an edge of the sample collection medium 252 between the ledge 562 and the distal end 512 of the inlet portion 510. For example, the snap-fit ​​connection can be formed in part by an undercut 553 on the base 550 and by a protrusion (not shown) on the inlet portion 510.

[0066] The inlet portion 510 (shown in more detail in FIGS. 13A-13D) may form a support grid 540. The piercing element 520 may extend from and be supported by the support grid 540. The piercing element 520 may have a longitudinal axis A520 that extends along a central longitudinal axis A530 of the mouthpiece 530. Alternatively, the piercing element 520 may be disposed off-center (not coaxial) with respect to the inlet portion 510. The piercing element 520 may have any suitable shape. In some embodiments, such as those shown in FIGS. 12C, 12D, 13B, and 13C, the piercing element 520 may be a hollow needle. The piercing element 520 may have a shaft 522 with a hollow center 528. The piercing element may extend from the support grid 540 to a piercing tip 521. The piercing tip 521 is recessed within the inlet portion 510. The piercing tip 521 is recessed from the inlet end of the mouthpiece 530 by a distance D521.

[0067] The support grid 540 may have any suitable shape. In the illustrated exemplary embodiment, the support grid 540 has a wheel-and-spoke configuration with a number of spokes 541 extending from a center of the support grid 540. The support grid 540 defines openings 544 between the spokes 541.

[0068] The base 550 (shown in more detail in FIGS. 14A-14E ) may include a second support grid 560. The distal fluid guide 525 may optionally extend distally (towards the assay) from the second support grid 560. The distal fluid guide 525 may extend along a central longitudinal axis A 530 of the mouthpiece 530. The second support grid 560 may also act as a media support for the sample collection medium 252. The second support grid 560 may have any suitable shape. In the illustrated exemplary embodiment, the second support grid 560 has a wheel-and-spoke configuration with a plurality of spokes 561 extending from a center of the support grid 560. The support grid 560 defines openings 564 between the spokes 561.

[0069] An inner wall 533 of the mouthpiece 530 may include a similar receiving element 235 (eg, a groove) configured to receive the binding element 25 of the elution fluid delivery element 20, as shown in FIG.

[0070] In another embodiment shown in Figures 15A-16D, the support grid 540' of the inlet piece 510' has spokes 541' angled downward from the inner wall 533 towards the piercing element 520. That is, the spokes 541' may be set at an angle that is not perpendicular to the central longitudinal axis A520 of the piercing element 520, and the ends of the spokes 541' attached to the piercing element 520 are lower (closer to the porous sample collection medium 252) than the opposite ends. Slanting the spokes 541' towards the porous sample collection medium 252 can help guide the elution fluid from the elution fluid delivery element 20 to the porous sample collection medium 252. The remaining parts of the mouthpiece 530' shown in Figures 15A-16D may be the same as or similar to the mouthpiece 530 shown in Figures 12A-14E.

[0071] In some embodiments, the piercing element is not coaxial with the mouthpiece. One example of an alternative mouthpiece 430 for use with the sample collection system of Figures 1A and 1B is shown in Figures 17A-17E. The mouthpiece 430 extends from an inlet end 438 to an outlet end 439 and defines an air inlet 431 at the inlet end 438. The mouthpiece 430 includes a piercing element 420 attached to an inner wall 433 of the mouthpiece 430 by an extension 424. The piercing element 420 includes a shaft 422 and a piercing tip 421. The piercing tip 421 is recessed a distance D421 from the inlet end 438 in an interior 432 of the mouthpiece 430. The extension 424 can position the piercing element 420 within the mouthpiece 430 such that the fluid guiding element 20 can be inserted into the mouthpiece 430 and pierced by the piercing element 420. The piercing element 420 may have any suitable shape, such as the hollow needle shown.

[0072] The mouthpiece 430 may include a support grid or platform 440 for supporting the porous sample collection medium 252. The platform 440 may be substantially planar and perpendicular to the central longitudinal axis A 430 of the mouthpiece. The inner wall 433 of the mouthpiece 430 may include a plurality of grooves or channels 435 that may function as fluid guides. The plurality of channels 435 may extend parallel to the longitudinal axis A 430 of the mouthpiece 430. The channels 435 may extend below the platform 440 into a conical lower portion of the mouthpiece 430. The platform 440 may also include a wicking channel 441 on the upper side of the platform 440. The wicking channel 441 may help guide eluent from the center of the platform 440 (and the sample collection medium 252) toward the inner wall 433. The mouthpiece may include a plurality of openings 444 between the platform 440 and the inner wall 433, where the platform 440 intersects with the channels 435 (see FIG. 17C).

[0073] When the mouthpiece 430 is used, after the elution fluid delivery element 20 is inserted into the inlet end 438 of the mouthpiece 430, the piercing element 420 pierces the elution fluid delivery element 20 and elution fluid can flow from the pierced opening through or along the piercing element 20 and / or the channel 435. The elution fluid elutes the collected sample from the sample collection medium 252 and may be further transported along the wicking channel 441 of the platform 440, through the opening 444, down the channel 435 below the platform 440 towards the sample receiving area 31 of the assay.

[0074] The mouthpiece 430 may be coupled to the housing 11 of the sample collection device by any suitable mechanism, including using a mechanical connection (a bayonet fit, a snap fit, a pressure fit, an interference fit, a threaded fit, etc.), adhesive, or welding.

[0075] In some embodiments, the elution fluid delivery element includes a second reservoir containing fluid and the mouthpiece includes two piercing elements for the two reservoirs. An example of a mouthpiece inlet portion 710 having two piercing elements 720, 780 is shown in FIG. 18A. The first piercing element 720 and the second piercing element 780 both extend proximally from the support element 740 to a first piercing tip 721 and a second piercing tip 781, respectively. The tips 721, 781 of the first piercing element 720 and the second piercing element 780 are recessed a distance D721 into the mouthpiece (inlet portion) 710 as described above. The first piercing element 720 and the second piercing element 780 may be recessed the same distance or different distances, so long as both piercing elements 721, 781 are recessed enough to reduce or minimize the possibility of a user inadvertently contacting the tips 721, 781 of the first piercing element 720 and the second piercing element 780. For example, the first piercing element 720 and the second piercing element 780 may be independently recessed by 4 mm or more, 5 mm or more, or 6 mm or more. The first piercing element 720 and the second piercing element 780 may independently be recessed by a distance of 10 mm or less, 9 mm or less, or 8 mm or less. The inlet portion 710 may otherwise be similar to the inlet portion 510 shown in Figures 13A-13D and includes an air inlet 731, an airflow path 732, and a distal end 712. The support element 740 may have any suitable structure and may include spokes 741 or ribs with spaces formed between the spokes 741 or ribs for fluid flow. The inlet portion 710 may be used with the base 550 shown in Figures 14A-14E to form a mouthpiece. However, the two piercing elements 720, 780 are not limited to a particular shape of the mouthpiece, inlet portion 710, or base 550 and may be provided on any mouthpiece or nosepiece discussed herein.

[0076] An elution fluid delivery element 70 having two reservoirs 71, 72 is shown in Figures 18B and 18C. The elution fluid delivery element 70 is otherwise similar to the elution fluid delivery element 20 shown in Figures 10A and 10B, for example, and includes two coupling elements 75 (e.g., alignment pins) and a membrane 73. The interior of the elution fluid delivery element 70 is divided into a first reservoir 71 and a second reservoir 72 by an inner wall 74. The first reservoir 71 and the second reservoir 72 each contain a fluid. For example, the first reservoir 71 may contain an elution fluid (e.g., a fixed amount of elution fluid), and the second reservoir 72 may contain a solution having one or more reagents or other components. The one or more reagents or other components may be involved, for example, in the elution or transport of the collected sample, or in a reaction or analysis when the collected sample reaches the assay 30. The second reservoir 72 may be enclosed by the same membrane 73 as the first reservoir 71, or may be enclosed by a second membrane.

[0077] When the elution fluid delivery element 70 is received in the airflow path 732 of the mouthpiece (inlet portion) 710, the first piercing element 720 and the second piercing element 780 pierce the first reservoir 71 and the second reservoir 72. The coupling element 75 (e.g., alignment pin) can help guide the elution fluid delivery element 70 into position in the mouthpiece (inlet portion) 710. The inner wall of the mouthpiece (inlet portion) 710 may include a corresponding receiving element such as a groove or slot (not shown). The elution fluid delivery element 70 may be constructed to deliver fluid from the second reservoir 72 simultaneously with the elution fluid from the first reservoir 71. The elution fluid delivery element 70 may be constructed to deliver fluid from the second reservoir 72 in succession with the elution fluid from the first reservoir 71.

[0078] The housing may include a pre-filter or screen disposed in the airflow path prior to (upstream of) the porous sample collection medium. The screen may be constructed to trap larger particles (larger than viruses or pathogens) and prevent such particles from reaching the porous sample collection medium. The exhaled airflow may pass through the thickness of the pre-filter or screen. The pre-filter or screen may at least partially occlude the airflow path. In some cases, the pre-filter or screen may have a major plane perpendicular to the direction of the exhaled airflow 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 larger particles from the exhaled airflow passing through the pre-filter or screen. In some cases, the pre-filter or screen may be a non-woven layer that does not have a static charge. In some embodiments, the pre-filter or screen does not trap significant amounts of viral, pathogen, or other analyte material, but rather allows them to pass through the pre-filter 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, hi some embodiments, the prefilter or screen is part of a support grid or support element structure.

[0079] The porous sample collection medium may be a nonwoven material capable of capturing pathogens, viruses, or other analytes from the exhaled airstream. According to one embodiment, the porous sample collection medium is a nonwoven material carrying an electrostatic charge. The electrostatic charge may enable capturing pathogens, viruses, or other analytes from the exhaled airstream. In some cases, the porous sample collection medium may be a hydrophobic nonwoven material. In other cases, the porous sample collection medium may be a hydrophilic nonwoven material. The porous sample collection medium may be a hydrophobic nonwoven material carrying an electrostatic charge configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The porous sample collection medium may be a hydrophilic nonwoven material configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The term "hydrophobic" refers to a material having a water contact angle of 90 degrees or more, or between about 90 degrees and about 170 degrees, or between about 100 degrees and about 150 degrees. The term "hydrophilic" refers to a material having a water contact angle of less than 90 degrees. Water contact angles are measured using the ASTM D5727-1997 Standard Test Method for Surface Wettability and Absorbency of Sheet Materials using an automated contact angle tester.

[0080] The porous sample collection medium may be formed of any suitable material capable of capturing viruses, pathogens or other analytes from the exhaled airstream and releasing the captured viruses, pathogens or other analytes upon contact with an eluent such as saline. The porous sample collection medium may be formed of a polymeric material. The porous sample collection medium may be formed of a polyolefin. Examples of suitable polyolefins include polypropylene, polylactic acid, and the like, and combinations thereof. In one embodiment, the porous sample collection medium may be formed of polypropylene. In one embodiment, the porous sample collection medium is formed of polylactic acid. One exemplary porous sample collection medium is commercially available under the trade name FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus Air Filter Merv 13 from 3M Company (St. Paul MN, USA).

[0081] The porous sample collection medium may have a thickness (orthogonal to the major surface) of 200 μm or more, or 250 μm or more. The porous sample collection medium may have a thickness of 750 μm or less, or 1000 μm or less. The porous sample collection medium may have a thickness in the range of 200 μm to 1000 μm, or 250 μm to 750 μm. The porous sample collection medium may have a thickness of 1 cm 2 More than 2cm 2 The porous sample collection medium may have a major planar surface area (per side) of 3 cm or more. 2 Less than or equal to 4cm 2 The porous sample collection medium may have a major planar surface area of ​​1 cm 2 ~4cm 2 , or 2 cm 2 ~3cm 2 The surface area of ​​the major planar surface may be in the range of 0.1 to 1.0 mm.

[0082] In some embodiments, the porous 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. The particular pleating pattern or shape of the pleated feature is a generally frustoconical pleated shape and / or pattern, although any desired pattern and shape may be used.

[0083] According to one embodiment, the sample is eluted from the loaded sample collection medium by dispensing a liquid (eluent) on the loaded sample collection medium. The sample can be eluted by a fixed amount of liquid (eluent). The eluent may be an aqueous liquid. The eluent may be a buffer solution. The eluent may be an aqueous buffer solution. The eluent may be saline. The eluent may include a surfactant. The eluent may have a contact angle greater than 90 degrees when measured on the porous sample collection medium. The eluent may be saline containing a surfactant. The eluent (e.g., buffer or saline) may include 0.1% or more, or 0.5% or more, and up to 1% or up to 2% by weight of a surfactant. When provided as a fixed amount, the eluent may have a volume of 50 μL or more, 100 μL or more, 150 μL or more, or 200 μL or more. The metered volume may be 500 μL or less, 400 μL or less, 300 μL or less, or 250 μL or less. The metered volume may be 50 μL to 500 μL, or 100 μL to 400 μL. According to one embodiment, the reservoir of the eluent delivery element contains an eluent, which may be an aqueous buffer solution or saline. According to one embodiment, the reservoir of the eluent delivery element contains a metered volume of eluent. According to one embodiment, the reservoir of the eluent delivery element contains a volume of eluent that is greater than the metered volume.

[0084] An eluent may be applied onto the loaded porous sample collection medium. The eluent may be wicked up and / or guided by a piercing element. The eluent may pass through the surface and thickness of the loaded porous sample collection medium and flow out of the porous sample collection medium carrying any viruses, pathogens, or other analytes that were present on the loaded porous sample collection medium. This loaded eluent (e.g., eluate) may flow over an assay and be tested for the presence of pathogens or other analytes of interest. The eluent may be guided over the assay by a fluid flow guide.

[0085] The assays included in the sample collection system may be any suitable assay. In some embodiments, the assays are lateral flow assays ("LFA") or vertical flow assays ("VFA"). LFAs and VFAs are generally paper-based platforms for the detection and quantification of analytes in complex mixtures, including biological samples such as saliva, urine, etc. LFAs and VFAs are typically easy to use and can be used by both professionals in a health care environment or laboratory as well as laypersons at home. Typically, a liquid sample is placed in a sample receiving area on the assay and is transported along the device to the test area by capillary flow. LFAs and VFAs are typically based on antigens or antibodies immobilized on the test area, which selectively react with the analyte of interest. Results are typically displayed in less than 30 minutes, for example within 5-30 minutes. LFAs and VFAs can be tailored to test for a variety of viruses and other pathogens, as well as many other types of analytes. According to one embodiment, the assays used in the sample collection system of the present disclosure are constructed for the detection of a target virus, target pathogen, or other target analyte. According to one embodiment, the assays used in the sample collection system of the present disclosure are constructed for the detection of a target virus, target pathogen, or other target analyte that may be present in a subject's exhaled breath stream.

[0086] The housing of the sample collection device may be formed of a rigid material such as plastic, or a paper-based material such as paperboard or cardboard. In some embodiments, the housing is made of plastic. In some embodiments, at least a portion of the housing is transparent. For example, the housing may include a transparent material in the area of ​​the assay result display. The housing may include an observation window (either a transparent material or an opening) in the area of ​​the result display. In some cases, the entire housing may be made of a transparent material. In other embodiments, the material may be a soft material, such as closed cell foam.

[0087] The sample collection system may be provided as a kit. The kit may include a sample collection device, an elution fluid delivery element, and an assay, as described above. The kit may include a sample collection device including a housing with an airflow path having a length extending from a proximal end with an air inlet to a distal end, a sample collector including a porous sample collection medium arranged to occlude the airflow path, and a piercing element arranged in the airflow path and extending from the sample collector along the length of the airflow path. The kit may further include an elution fluid delivery element including a reservoir containing elution fluid and a membrane arranged at a mating end of the reservoir and sealing the reservoir, the mating end being constructed to mate with a proximal end of the airflow path such that the piercing element pierces the membrane. The kit may further include a lateral flow assay configured or configurable to receive a sample from the sample collection element.

[0088] A method of obtaining a sample using a sample collection system includes blowing into a proximal end of an airflow path to collect a sample on a porous sample collection medium. The exhaled airflow passes through the porous sample collection medium, which is constructed to capture viruses, other pathogens, or other analytes from the exhaled airflow. This forms a loaded medium. The method further includes coupling a coupling end of an elution fluid delivery element to a first end of the airflow path. Coupling the elution fluid delivery element to the sample collection device perforates a membrane of the elution fluid delivery element, allowing the elution fluid to flow from a reservoir onto the loaded medium. The method can include transferring a quantity of the elution fluid onto the loaded medium to elute the collected sample from the porous sample collection medium. The elution fluid elutes the sample from the loaded medium. The elution fluid containing the sample (eluate) can flow further onto a lateral flow assay, depositing the collected sample onto the lateral flow assay.

[0089] The method can further include reading the test results from the lateral flow assay. The results may be read through an observation window on the housing of the sample collection device.

[0090] Below is a list of exemplary embodiments according to the present disclosure.

[0091] Embodiment 1 is a sample collection system comprising a sample collection device and an elution fluid delivery element, wherein the sample collection device comprises a housing having an airflow path extending from a proximal end to a distal end having an air inlet, a piercing element disposed within the airflow path, and a sample collector having a porous sample collection medium disposed to block the airflow path, and the elution fluid delivery element comprises a reservoir for containing elution fluid and a membrane disposed at a mating end of the reservoir and sealing the reservoir, the mating end being constructed to be mated with a proximal end of the airflow path such that the piercing element pierces the membrane.

[0092] Embodiment 2 is the sample collection system of embodiment 1, further comprising a lateral flow assay adjacent to the porous sample collection medium.

[0093] Embodiment 3 is a sample collection system according to embodiment 2, wherein the porous sample collection medium is in direct contact with the lateral flow assay.

[0094] Embodiment 4 is the sample collection system of any one of embodiments 1 to 3, wherein the housing comprises a mouthpiece that defines a proximal end of the airflow pathway.

[0095] Embodiment 5 is a sample collection system according to embodiment 4, wherein the piercing element is recessed within the mouthpiece.

[0096] Embodiment 6 is a sample collection system according to any one of embodiments 1 to 5, wherein the reservoir comprises a cylindrical body.

[0097] Embodiment 7 is a sample collection system described in any one of embodiments 1 to 6, wherein the airflow path has a cylindrical internal cavity and the coupling end of the eluent delivery element is constructed to be at least partially received within the airflow path.

[0098] Embodiment 8 is a sample collection system described in any one of embodiments 1 to 7, wherein the eluent delivery element comprises a binding element and the airflow path defines an inner surface comprising a corresponding receiving element constructed to receive the binding element.

[0099] Embodiment 9 is a sample collection system according to any one of embodiments 1 to 8, wherein the sample collection device and the eluent delivery element are coupled by a bayonet coupling, an interference fit, a snap fit, or a threaded coupling.

[0100] Embodiment 10 is a sample collection system according to any one of embodiments 1 to 9, wherein the eluent delivery element is constructed for rotatable insertion into the airflow path.

[0101] Embodiment 11 is a sample collection system according to any one of embodiments 1 to 10, wherein the sample collector comprises a support grid, and the piercing elements extend from the support grid.

[0102] Embodiment 12 is a sample collection system according to any one of embodiments 1 to 11, wherein the piercing element comprises a needle.

[0103] Embodiment 13 is a sample collection system according to any one of embodiments 1 to 12, wherein the piercing element comprises a blade.

[0104] Embodiment 14 is a sample collection system according to any one of embodiments 1 to 13, wherein the airflow pathway has a central longitudinal axis and the piercing elements extend parallel to the central longitudinal axis.

[0105] Embodiment 15 is a sample collection system according to any one of embodiments 1 to 14, wherein the piercing element is not coaxial with the airflow path.

[0106] Embodiment 16 is a sample collection system described in any one of embodiments 1 to 15, wherein the piercing element has a longitudinal central axis and a cross-sectional shape along the longitudinal central axis that is non-circular, and optionally, the cross-sectional shape is arrowhead-shaped.

[0107] Embodiment 17 is a sample collection system described in any one of embodiments 1 to 16, wherein the piercing element has a longitudinal central axis and a first cross-sectional shape and a second cross-sectional shape along the longitudinal central axis, the second cross-sectional shape being different from the first cross-sectional shape.

[0108] Embodiment 18 is a sample collection system described in any one of embodiments 1 to 17, wherein the piercing element has a longitudinal central axis and a first cross-sectional diameter and a second cross-sectional diameter along the longitudinal central axis, the second cross-sectional diameter being different from the first cross-sectional diameter.

[0109] Embodiment 19 is a sample collection system according to any one of embodiments 1 to 18, wherein the piercing element comprises a hollow center extending from an open first end to an opposing open second end.

[0110] Embodiment 20 is a sample collection system according to any one of embodiments 1 to 19, wherein the piercing element comprises a surface texture or material configured to promote wicking or capillary flow.

[0111] Embodiment 21 is a sample collection system according to any one of embodiments 2 to 20, wherein the piercing element comprises a distal section that is in direct contact with the sample receiving area of ​​the lateral flow assay.

[0112] Embodiment 22 is a sample collection system described in embodiment 21, wherein the distal section includes a surface texture or material configured to promote wicking or capillary flow.

[0113] Embodiment 23 is a sample collection system described in any one of embodiments 1 to 22, wherein the sample collection system has a non-binding position and a binding position in which the eluent delivery element is coupled to the sample collection device, and the eluent delivery element is constructed to deliver eluent from the reservoir onto the porous sample collection medium at the binding position.

[0114] Embodiment 24 is the sample collection system of embodiment 23, wherein the eluent delivery element is constructed to deliver a metered amount of eluent from the reservoir onto the porous sample collection medium at the binding location.

[0115] Embodiment 25 is the sample collection system of embodiment 23, wherein the sample collection system comprises an indicator configured to indicate whether the sample collection system is in the binding position.

[0116] Embodiment 26 is the sample collection system of embodiment 25, wherein the indicator comprises an audible indicator or a visual indicator.

[0117] Embodiment 27 is a sample collection system described in any one of embodiments 1 to 26, wherein the airflow path has a longitudinal central axis, the eluent delivery element has a piercing position and a fluid delivery position, and the fluid delivery position is axially proximal to the piercing position.

[0118] Embodiment 28 is a sample collection system according to any one of embodiments 1 to 27, wherein the housing comprises a support element in the airflow path and a protrusion extending from the support element in a direction opposite the piercing element.

[0119] Embodiment 29 is the sample collection system of embodiment 28, wherein the protrusion deforms the porous sample collection medium into a conical shape.

[0120] Embodiment 30 is a sample collection system according to any one of embodiments 2 to 29, wherein the piercing element defines a fluid flow guide extending distally from the sample collector.

[0121] Embodiment 31 is a sample collection system according to embodiment 30, wherein the fluid flow guide comprises a distal section that is in direct contact with the sample receiving area of ​​the lateral flow assay.

[0122] Embodiment 32 is a sample collection system described in embodiment 31, wherein the distal section includes a surface texture or material configured to promote wicking or capillary flow.

[0123] Embodiment 33 is a sample collection system according to any one of embodiments 1 to 27, wherein the sample collection device comprises a mouthpiece defining an inner surface, the inner surface comprising a wicking channel.

[0124] Embodiment 34 is a sample collection system according to embodiment 33, wherein the mouthpiece comprises a platform and the porous sample collection medium is disposed on the platform.

[0125] Embodiment 35 is a sample collection system described in any one of embodiments 1 to 34, wherein the eluent delivery element comprises a second reservoir for containing a fluid, the second reservoir being sealed by a second membrane.

[0126] Embodiment 36 is a sample collection system according to embodiment 35, wherein the piercing element comprises two prongs defining a first piercing tip and a second piercing tip.

[0127] Embodiment 37 is a sample collection system according to embodiment 36, wherein the eluent delivery element is constructed to deliver fluid from the second reservoir simultaneously with the eluent from the first reservoir.

[0128] Embodiment 38 is a sample collection system according to any one of embodiments 1 to 37, wherein the porous sample collection medium comprises a nonwoven material.

[0129] Embodiment 39 is the sample collection system of embodiment 38, wherein the nonwoven material comprises polylactic acid, polypropylene, or a combination thereof.

[0130] Embodiment 40 is the sample collection system of embodiment 39, wherein the porous sample collection medium carries an electrostatic charge.

[0131] Embodiment 41 is the sample collection system of any one of embodiments 1-40, wherein the eluent delivery element is configured to deliver a fixed amount of eluent from the reservoir, the fixed amount having a volume of 50 μL or more, 100 μL or more, 150 μL or more, or 200 μL or more. The fixed amount can have a volume of 500 μL or less, 400 μL or less, 300 μL or less, or 250 μL or less. The fixed amount can have a volume of 50 μL to 500 μL, or 100 μL to 400 μL.

[0132] Embodiment 42 is a sample collection system according to any one of embodiments 1 to 41, wherein the eluent comprises an aqueous liquid, and optionally a buffer solution or an aqueous buffer solution, optionally the eluent comprises saline, and further optionally the eluent comprises a surfactant.

[0133] Embodiment 43 is the sample collection system of any one of embodiments 1-42, wherein the piercing element is recessed a distance of 4 mm or more, 5 mm or more, or 6 mm or more. The piercing element may be recessed a distance of 10 mm or less, 9 mm or less, or 8 mm or less. The piercing element may be recessed between 4 mm and 10 mm, or between 5 mm and 8 mm.

[0134] Embodiment 44 is a kit comprising a sample collection device, an elution fluid delivery element, and an assay, wherein the sample collection device comprises a housing comprising an airflow path having a length extending from a proximal end to a distal end comprising an air inlet, a sample collector comprising a porous sample collection medium arranged to occlude the airflow path, and a piercing element arranged within the airflow path and extending from the sample collector along the length of the airflow path, the elution fluid delivery element comprises a reservoir for containing elution fluid and a membrane arranged at a mating end of the reservoir and sealing the reservoir, the mating end being constructed to mating with the proximal end of the airflow path such that the piercing element pierces the membrane, and the assay is configured or configurable to receive a sample from the sample collection element.

[0135] Embodiment 45 is a kit comprising a sample collection device according to any one of embodiments 1 or 3 to 43 and an assay according to embodiment 2 configured or configurable to receive a sample from the sample collection element.

[0136]

[0081] Embodiment 46 is a method of obtaining a sample using a sample collection system, the sample collection system comprising: a sample collection device comprising: a housing having an airflow path extending from a proximal end with an air inlet to a distal end, a piercing element disposed within the airflow path, and a sample collector having a porous sample collection medium disposed to occlude the airflow path; an elution fluid delivery element comprising a reservoir containing an elution fluid and a membrane disposed at a mating end of the elution fluid delivery element and sealing the reservoir, the mating end being constructed to mate with a proximal end of the airflow pathway such that the piercing element pierces the membrane; The method includes blowing into a proximal end of the airflow path to collect a sample on the porous sample collection medium, coupling a coupling end of an elution fluid delivery element to the proximal end of the airflow path, and transferring a fixed amount of elution fluid from a reservoir onto the porous sample collection medium to elute the collected sample from the porous sample collection medium.

[0137] Embodiment 47 is the method of embodiment 46, wherein the sample collection system comprises a lateral flow assay, and eluting the collected sample deposits an eluate containing the collected sample onto the lateral flow assay.

[0138] 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 implementations without departing from the scope of the present disclosure. It should be understood that the present 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 the present disclosure, which is intended to be limited only by the scope of the claims described herein.

Claims

1. a sample collection device; an eluent delivery element; and 1. A sample collection system comprising: The sample collection device comprises: a housing having an airflow path extending from a proximal end having an air inlet to a distal end; a piercing element disposed within the airflow path; a sample collector comprising a porous sample collection medium positioned to occlude the airflow path; Equipped with The eluent delivery element comprises: a reservoir containing an eluent; a membrane disposed at a connecting end of the reservoir, sealing the reservoir; Equipped with the coupling end is constructed to couple with the proximal end of the airflow pathway and to be at least partially received within the airflow pathway such that the piercing element pierces the membrane; Sample collection system.

2. 10. The sample collection system of claim 1, further comprising a lateral flow assay adjacent to the porous sample collection medium, optionally in direct contact with the lateral flow assay.

3. The sample collection system of claim 1 , wherein the housing includes a mouthpiece defining the proximal end of the airflow path, and the piercing element is recessed within the mouthpiece.

4. The sample collection system of claim 1 , wherein the airflow path has a central longitudinal axis and the piercing element extends parallel to the central longitudinal axis.

5. The sample collection system of claim 1 , wherein the piercing element comprises a hollow center extending from a first open end to an opposite second open end.

6. The sample collection system of claim 1 , wherein the piercing element includes a surface texture or material configured to promote wicking or capillary flow.

7. 3. The sample collection system of claim 2, wherein the piercing element comprises a distal section that directly contacts the sample receiving area of ​​the lateral flow assay, and optionally the distal section comprises a surface texture or material configured to promote wicking or capillary flow.

8. 2. The sample collection system of claim 1, wherein the sample collection system has a non-binding position and a binding position in which the eluent delivery element is coupled to the sample collection device, and the eluent delivery element is configured to deliver a fixed amount of the eluent from the reservoir onto the porous sample collection medium at the binding position.

9. 2. The sample collection system of claim 1, wherein the housing comprises a support element within the airflow path and a protrusion extending from the support element in a direction opposite the piercing element, the protrusion deforming the porous sample collection medium into a conical shape.

10. 3. The sample collection system of claim 2, wherein the piercing element defines a fluid flow guide extending distally from the sample collector, optionally the fluid flow guide including a distal section that directly contacts a sample receiving area of ​​the lateral flow assay, and optionally the distal section including a surface texture or material configured to promote wicking or capillary flow.

11. 10. The sample collection system of claim 1, wherein the sample collection device comprises a mouthpiece defining an inner surface, the inner surface comprising a wicking channel, and optionally, the mouthpiece comprises a platform, and the porous sample collection medium is disposed on the platform.

12. 2. The sample collection system of claim 1, wherein the eluent delivery element comprises a second reservoir containing a fluid, the second reservoir being sealed by a second membrane, and optionally the piercing element comprises two prongs defining a first piercing tip and a second piercing tip, and optionally the eluent delivery element is configured to deliver the fluid from the second reservoir simultaneously with the eluent from the first reservoir.

13. 10. The sample collection system of claim 1, wherein the porous sample collection medium comprises a nonwoven material, optionally comprising polylactic acid, polypropylene, or a combination thereof, and optionally wherein the porous sample collection medium carries an electrostatic charge.

14. a sample collection device; an eluent delivery element; and Assay and A kit comprising: the sample collection device a housing having an airflow path having a length extending from a proximal end having an air inlet to a distal end; a sample collector comprising a porous sample collection medium positioned to occlude the airflow path; a piercing element disposed within the airflow path and extending from the sample collector along the length of the airflow path; Equipped with the eluent delivery element comprises: a reservoir containing an eluent; a membrane disposed at a connecting end of the reservoir, sealing the reservoir; Equipped with the coupling end is configured to couple with the proximal end of the airflow pathway such that the piercing element pierces the membrane; the assay is configured or configurable to receive a sample from the sample collection element; kit.

15. 1. A method of obtaining a sample using a sample collection system, the sample collection system comprising: a housing having an airflow path extending from a proximal end having an air inlet to a distal end; a piercing element disposed within the airflow path; and a sample collector comprising a porous sample collection medium positioned to occlude the airflow path; a sample collection device comprising: a reservoir containing an eluent; and a membrane sealing the reservoir; an eluent delivery element comprising: Equipped with the membrane is disposed at a binding end of the eluent delivery element; the coupling end is configured to couple with the proximal end of the airflow pathway such that the piercing element pierces the membrane; The method comprises: blowing into the proximal end of the airflow path to collect a sample on the porous sample collection medium; coupling the coupling end of the eluent delivery element to the proximal end of the airflow pathway; transferring a measured amount of the eluent from the reservoir onto the porous sample collection medium to elute the collected sample from the porous sample collection medium; Including, Optionally, the method, wherein the sample collection system comprises a lateral flow assay, and wherein eluting the collected sample deposits an eluate containing the collected sample onto the lateral flow assay.

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