Sample collection devices, systems and methods

Abstract

The present disclosure relates to sample collection devices, as well as sample collection and testing devices. The devices described herein include a housing that defines a fluidic channel from a first portion to a second portion. The device further includes a porous sample collection medium disposed within the housing and in fluidic communication with the fluidic channel. The device further includes a fluid inlet port disposed in fluidic communication with the porous sample collection medium. The fluid inlet port is configured to direct a test fluid onto the porous sample collection medium. The sample collection device further includes an assay configured to receive the fluid incident on the porous sample collection medium (and an eluent) and test the eluent for the presence (or absence) of a pathogen or virus.

Description

[Technical field]

[0001] SUMMARY The present disclosure relates generally to sample collection devices and systems, methods for using sample collection devices and systems, and sample collection and testing devices and systems. [Background technology]

[0002] As Covid-19 reaches pandemic status, increasing availability of diagnostic tests is critical to help identify and control severe disease. The disease has highlighted the need for such diagnostic tests to be widely available even after the pandemic ends. Diagnostic tests used to test for the presence of viruses or other pathogens in the respiratory tract, throat, or nasopharynx typically involve the insertion of a swab into the back of the nasal cavity, the middle turbinate region of the nasal cavity, the anterior nares, or into the throat to obtain a sample. The swab is then inserted into a container and analyzed or sent to a laboratory for processing. Other diagnostic tests involve collecting a saliva sample and then placing it into a container. Currently available at-home virus tests (e.g., COVID-19 tests) involve a nasal swab and a test kit (e.g., Ellume™ test, Abbot™ BinaxNOW™ test, and Lucira™ all-in-one test kit). Tests that utilize nasal swab samples or saliva compete with contaminants that can interfere with various diagnostic tests. As a result, these sample types require purification steps when using RT-PCR molecular tests. Summary of the Invention

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

[0004] Thus, the inventors of the present disclosure have recognized the need for an inexpensive, easy-to-use, reliable sample collection system that can be used (even by laypeople) to obtain samples for testing for the presence of target viruses, target pathogens, or other target analytes in the collected samples. The inventors of the present disclosure have sought to create an easy-to-use, inexpensive, integrated sample collection and testing device in which sample collection and sample testing are performed in a single integrated device that can be used anywhere by laypeople. In addition, the inventors have sought to create an integrated sample collection and testing device that does not require the user to receive a nasopharyngeal swab or other nasal or oral swab.

[0005] Thus, the inventors of the present disclosure have invented the sample collection and testing devices and methods described herein. The sample collection and testing devices described herein can collect aerosol (in some cases, bioaerosol) samples and test the aerosol for the presence (or absence) of pathogens or viruses. The bioaerosol can be, for example, from nasal or oral exhalation. Thus, the sample collection and testing devices described herein enable rapid testing of aerosol (in some cases, bioaerosol) samples, increasing efficiency and lowering cost and complexity. Furthermore, the disclosed sample collection devices can minimize the possibility of sample contamination since both sample collection and testing can be performed in a single unit. In some embodiments, samples can be collected using the sample collection devices described herein and sent to a laboratory for processing. Furthermore, the disclosed sample collection devices can be easily used by a user (e.g., a potential patient) without any prior training or expert assistance.

[0006] Some embodiments of the present disclosure relate to sample collection and testing devices that include a sample collection portion or device that can be attached to a sample testing portion or device to form an integrated sample collection and testing device. [Brief description of the drawings]

[0007] Exemplary embodiments disclosed herein may be more fully understood by consideration of the following Detailed Description in conjunction with the following figures. The figures are not necessarily drawn to scale. Like numbers used in the figures indicate like components. However, it will be understood that the use of a number to indicate a component in a given figure is not intended to limit the component in another figure that is indicated with the same number.

[0008] [Figure 1] 1 is a schematic front perspective view of one exemplary embodiment of a sample collection and testing device according to the present disclosure;

[0009] [Diagram 2] 2 is a schematic side view of the sample collection and testing device of FIG. 1.

[0010] [Figure 3A] 2 is a perspective schematic side view of a second portion of the sample collection device of FIG. 1.

[0011] [Figure 3B] 2 is a perspective schematic top view of a second portion of the sample collection device of FIG. 1.

[0012] [Figure 4A] 3C is a perspective schematic side view of a second portion of the sample collection device shown in FIGS. 3A and 3B approaching connection with a first portion of the sample collection device to form a combination of the sample collection device of FIG. 1.

[0013] [Figure 4B] 3C is a perspective schematic bottom view of a second portion of the sample collection device shown in FIGS. 3A and 3B connecting to a first portion of the sample collection device to form the sample collection device shown in FIG. 1. FIG.

[0014] [Diagram 5] FIG. 4C is an exploded schematic side view of the connected first and second parts shown in FIG. 4B.

[0015] [Figure 6] FIG. 6 is a schematic side view of the three-dimensional porous sample collection device of FIG. 4B or FIG. 5.

[0016] [Figure 7A] FIG. 2 is a perspective schematic side view of a sample collection device, including an optional latch system.

[0017] [Figure 7B] FIG. 7B is an enlarged view of a portion of the sample collection system of FIG. 7A.

[0018] [Figure 7C] FIG. 7B is a perspective schematic bottom view of the sample collection device of FIG. 7A.

[0019] [Figure 7D] FIG. 7D is a close-up view of the sample collection device of FIG. 7C along the longitudinal axis of the testing device.

[0020] [Figure 8] 8A-8D are perspective schematic diagrams of exemplary embodiments of attachment mechanisms including the latch system of FIGS. 7A-7D.

[0021] [Figure 9A] 1A and 1B are perspective and top schematic views, respectively, of an exemplary pleating mechanism that may optionally be included within a sample collection device of the present disclosure. [Figure 9B] 1A and 1B are perspective and top schematic views, respectively, of an exemplary pleating mechanism that may optionally be included within a sample collection device of the present disclosure.

[0022] [Figure 10] FIG. 9C is a schematic side view of a sample collection device including the pleating mechanism of FIGS. 9A and 9B and the latch system of FIGS. 7A-8.

[0023] [Figure 11] FIG. 11 is a partial cutaway view of the sample collection device of FIG.

[0024] [Figure 12] 12A-12C are photographs of pleated sample collection media formed by the pleating mechanism of FIGS. 9A-11. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Some embodiments of the present disclosure relate to sample collection and testing devices that include a sample collection portion or device that can be attached to a sample testing portion or device to form an integrated sample collection and testing device.

[0026] 1 and 2 show different views of an exemplary sample collection device 110 connected to an exemplary sample testing device 150, which together form an integrated sample collection and testing device 100. A user exhales into the mouthpiece or breath receiving portion 108 or first portion 104 to introduce an exhaled airflow into the sample collection device 102. The user's exhaled air can be nasal or mouth exhaled. The exhaled airflow flows through fluid channels in the blow tube 110 and onto the sample collection medium 112. Viral or pathogenic material enters and adheres or binds to the porous sample collection medium 112, forming a porous sample collection medium loaded with exhaled material (referred to as loaded sample collection medium).

[0027] The user then attaches (either permanently or temporarily) the sample testing device 150 to the sample collection device 102, for example, by snapping the two pieces together. In some embodiments, the sample collection device 102 and the sample testing device 150 are connected to form the integrated sample collection and testing device 100 before the user exhales into the mouthpiece or breath receiving portion 108 or first portion 104. The user then introduces fluid into the device (e.g., by a dropper or bottle) through one or more fluid inlet ports 118. In this embodiment, the one or more fluid inlet ports 118 are the same holes or openings that form the blow tube 110. The fluid introduced through the one or more fluid inlet ports 118 enters the loaded porous collection medium 112 and forms an eluent that travels from the loaded porous collection medium 112 towards the assay 160 in the testing device 150. More specifically, the fluid travels through the loaded porous sample collection medium 112, carrying viral and pathogenic agents that were present on the loaded porous sample collection medium 112 in an eluent towards an assay 160 (not shown) for testing. Optionally, the sample testing device 150 includes a visual indicator 170 that informs a user of the presence or absence of viral or pathogenic material in the exhaled airstream that the user provided into the sample collection device 102.

[0028] The two-piece design of the sample collection and testing device 100 can facilitate disposability and / or reuse of one or more of the sample collection device 102 and / or the sample testing device 150. The two-piece design also allows a user to use a variety of sample testing devices with different assays, for example, to test for the presence of different viruses or pathogens.

[0029] Each of the portions of the sample collection and testing device described herein, and one embodiment thereof, designated sample collection and testing device 100, are described in more detail below. Sample Collection Device

[0030] As shown in FIG. 4A, the sample collection device 102 includes a first portion 104 and a second portion 106. The first portion 104 and the second portion 106 collectively form a housing that includes a fluid channel through which air and / or fluid (e.g., provided by a user's exhaled breath, e.g., referred to as an exhaled airflow) entering through the first portion 104 flows before exiting through the second portion 106. As used herein, the term "fluid" may refer to a liquid or a gas (i.e., air). Although the first portion 104 and the second portion 106 are shown here as separate and attachable, they may be integral (a single unit). When the first portion 104 and the second portion 106 are attachable, they may be permanently attachable or temporarily attachable. In some embodiments, the first portion 104 includes a mouthpiece or an exhaled breath receiving portion 108 (optional). The user exhales into the mouthpiece or breath receiving portion 108 or the first portion 104 to introduce the exhaled airflow 110 into the sample collection device 102. The mouthpiece or breath receiving portion is configured to receive the exhaled airflow from one or more of the mouth or nose. For example, the mouthpiece or breath receiving portion can be breathed into by contact with or adjacent to the mouth, or by contact with the nose / nostrils, or by contacting each individually or collectively. The exhaled airflow received by the mouthpiece or breath receiving portion can be one or both of mouth exhalation or nose exhalation. As used herein, the term "mouthpiece" is meant to refer to a breath receiving portion that can receive the exhaled air from the mouth or nose of the aerosol. The sample collection device 102 may be formed from a rigid material, such as plastic. In some embodiments, the first portion 104, the second portion 106, and / or the mouthpiece or breath receiving portion 108 may be integral parts of the housing 102, or one or more of them may be separate parts that can be removed, attached, or reattached.

[0031] The first portion 104 forms a blowtube 109 through which the exhaled airflow flows and through which fluid introduced through fluid inlet port 118 flows. The blowtube 109 includes an optional mouthpiece or exhaled air receiving portion 108 at a first end and an attachment mechanism 134 at a second end.

[0032] The attachment mechanism 134 in FIG. 4A is merely exemplary and others can be used. The exemplary attachment mechanism 134 includes an interference bump 114 that abuts against the wall of the media holder 130, one or more posts 136, and a number of fingers or contact elements 138 that engage with the media holder or receptacle 130 of the second portion 106. As shown in FIG. 2, the fingers or contact elements 138 have a generally L-shape that allows them to have some vertical and / or horizontal flexure, allowing them to act like a spring and provide some compliance to the system. In some embodiments, the fingers and / or posts flex tangentially to the plane of the assay test strip (in other words, flex in the Z direction / along the Z axis). In some embodiments, the compliance is along the longitudinal axis of the blow tube 110 or fluid channel. The one or more posts 136 can be stiffer than the fingers or contact elements 138. The post(s) 136 and finger elements 138 may hold the porous sample collection medium adjacent to or in direct contact with the assay. In the particular embodiment shown, the embodiment has four fingers or contact elements 138, although a greater or lesser number may be used and still be within the scope of the present application. The fingers or contact elements 138 also compensate for height variations within the system such that attachment of the first portion 104 and second portion 150 can be easily performed by the user and without excessive force that could rupture the porous sample collection medium 112, potentially invalidating the test.

[0033] The one or more fluid inlet ports 118 are disposed in fluid communication with the porous sample collection medium 112. The one or more fluid inlet ports 118 are capable of delivering a test fluid to the porous sample collection medium 112 via capillary action.

[0034] In some embodiments, the sample collection device 100 further includes a screen (not shown) disposed in the housing, blow tube 110, or mouthpiece or exhaled breath receiving portion 108 and upstream of the porous sample collection medium 112 to trap solid matter or debris (e.g., food particles, etc.) so that they do not enter the porous sample collection medium 112. In some embodiments, the screen includes one or more flow openings therethrough. The exhaled airflow passes through the thickness of the screen. The screen at least partially occludes the fluid channel. In some cases, the screen may have a major plane (not shown) that is perpendicular to the direction of the exhaled airflow (not shown) passing through the thickness of the screen. The screen may be a nonwoven layer configured to filter out larger particles from the exhaled airflow passing through the screen. In some cases, the screen may be a nonwoven layer that does not have an electrostatic charge. In some embodiments, the screen does not trap significant amounts of viral or pathogenic material, instead allowing them to pass through the screen. In some embodiments, the 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. In some embodiments, the screen does not capture or remove particles from the air stream having a size less than 100 micrometers, or 75 micrometers, or 50 micrometers, or 25 micrometers, or 10 micrometers, or 5 micrometers.

[0035] The second portion 106 includes (1) a sample media receptacle 130 in which the porous sample collection medium 112 is placed and held, and (2) an attachment mechanism 140 that attaches the sample collection device 102 to the sample testing device 150. In the exemplary embodiment of FIGS. 1-7, the attachment mechanism 140 includes a user attaching the sample testing device 150 to the sample collection device 110, for example, by snapping the two parts together. Those skilled in the art will appreciate that other attachment mechanisms and processes may be used, including, for example, sliding, threading, clipping, or rotating. The sample media holder or receptacle 130 holds the porous sample collection medium 112 within the sample collection device 102 such that the porous sample collection medium 112 is in fluid communication with and at least partially occludes the fluid channel.

[0036] 3A-4B illustrate the process by which the two-dimensional porous sample collection medium 112 is placed and held within the sample media receptacle 130 and how the two-dimensional porous sample collection medium 112 becomes a three-dimensional porous sample collection medium 112. As shown in FIG. 3A, the components of the porous sample collection medium 112 are placed within the sample media receptacle 130 on or adjacent to a sample media holder 132 (not shown) upon which the sample collection medium 112 rests. An exemplary sample media holder 132 (not shown) includes a lip or edge on the inner surface of the sample media receptacle 130 or a screen on the bottom of the sample media receptacle 130 upon which the porous sample collection medium 112 rests. The sample media holder 132 preferably allows air to pass through them. 3B shows the porous sample collection medium 112 resting on a sample media holder 132 (not shown) in the sample media receptacle 130. In some embodiments, the porous sample collection medium 112 is attached to the sample media holder 132 by an adhesive (e.g., a pressure sensitive adhesive, a porous adhesive, a structured adhesive, a heat activated adhesive, and / or a medical grade adhesive). The adhesive may be continuous or discontinuous. The adhesive may be patterned or continuous. In some embodiments, the porous sample collection medium 112 is attached to the sample media holder 132 by hook and loop and / or 3M™ Dual Lock™ removable fasteners. In some embodiments, the porous sample collection medium 112 is attached to the sample media holder 132 by mechanical attachment such as pins, stapling, tongue and groove connections, etc.

[0037] 4A and 4B show how the first portion 104 of the sample collection device 102 is attached to or disposed adjacent to the second portion 106 of the sample collection device 102. The attachment of the first portion 104 and the second portion 106 changes the porous sample collection medium 112 from a two-dimensional flat shape or structure to a three-dimensional shape or structure. The particular three-dimensional shape or structure shown in FIGS. 4B and 6 is a frustoconical shape or structure, however, one skilled in the art will understand that this shape can be altered depending on the number, shape, and arrangement of the post(s) 136 and fingers or contact elements 138 and / or the shape of the media receptacle 130. Furthermore, one skilled in the art will understand that although the two-dimensional porous sample collection medium 112 is shown as circular, it can be any desired shape including, for example, at least one of a circle, an oval, an ellipse, a square, a rectangle, a triangle, a trapezoid, a pentagon, a hexagon, a heptagon, or an octagon.

[0038] 7A-7D and 8 show an optional exemplary latch system that may be included in the attachment mechanism 140. The latch system includes two features, one or both of which may be optionally present. The first feature of the optional latch system is a front latch or clip 710 in / on the attachment mechanism that attaches to the sample testing device 150. The front latch or clip 710 prevents the sample testing device 150 from sliding or moving within the sample collection and testing device.

[0039] The second feature is a set of side latches or clips 720 that hold the sample testing device 150 securely in place. The illustrated embodiment has four side latches or clips 720 and two different types of latches. Latch 720a is a chamfered latch with an approximate 45 degree angle. Latch 720b is a rounded latch. The type, number, placement, or orientation of the latches on the clip 720 is merely exemplary and any desired type, number, placement, or orientation of the latches on the clip 720 can be used. The latches may all be the same or may be different from one another. In addition to holding the sample testing device 150 securely in place, the latches or clips 720 also ensure correct positioning, alignment, and / or attachment of the sample testing device 150 to the breath capture tube. Together, these attachment features hold the sample testing device 150 securely in place in all planes and orientations.

[0040] In some embodiments, the porous sample collection medium 112 may be replaceable and may be replaced by a user, as needed. For example, a user may exhale into the sample collection device 102 through the first portion 104 and load the porous sample collection medium 112 with a sample of the exhaled airflow to form a loaded porous sample collection medium. The user may then test the loaded porous sample collection medium 112 as described herein. After performing the test, the user may dispose of the loaded and tested porous sample collection medium 112, or may then replace the loaded porous sample collection medium 112 with an unloaded porous sample collection medium 112 using the process described above. Sample Test Device

[0041] The sample testing device 150 attaches to the sample collection device 102, for example, by snapping the two pieces together. The sample testing device 150 includes an assay 160 (not shown) that tests the eluent (and therefore, alternatively, the exhaled airflow) for the presence or absence of viruses or pathogens. The assay 160 is adjacent to or in direct contact with the porous sample collection medium 112 such that the eluent flowing from the porous sample collection medium 112, for example, by capillary action, enters the assay and carries the viral and pathogenic particles that were present on the loaded porous sample collection medium 112 in the eluent towards the assay 160 (not shown) for testing. In some embodiments, the assay is in direct physical contact with the porous sample collection medium to allow for the reception of the eluent from the porous sample collection medium. In some embodiments, the assay is in direct physical contact with the porous sample collection medium to allow for the reception of the eluent from the porous sample collection medium, but not in direct physical contact with the porous sample collection medium.

[0042] The assay 160 is configured to receive fluid from the porous sample collection medium 112. Specifically, the assay 160 is configured to receive a test fluid from the porous sample collection medium 112. Thus, the assay 160 is disposed in fluid communication with the porous sample collection medium 112. Generally, an eluent is collected and tested by the assay 150. In some embodiments, the assay 150 detects the presence of a virus or pathogen in the exhaled airflow 110 and / or the test fluid. In other words, the assay 150 first collects the eluent and then detects the presence of a virus or pathogen in the eluent.

[0043] The assay 160 qualitatively evaluates or quantitatively measures the presence, amount, and / or functional activity of an analyte on the sample collection medium 112. The analyte may be a drug, a biochemical, a chemical element or compound, or a microorganism or a cell in an organic sample. Exemplary biological assays include, for example, PCR-ELISA or fluorescence. The assay 160 can detect molecules, often at low concentrations, that are markers of disease or risk in an aerosol (in some cases, a bioaerosol) sample taken from a user / patient.

[0044] In some embodiments, the mechanism that holds the sample collection device and the sample testing device adjacent to one another limits movement of the sample collection device relative to the assay. In some embodiments, the limited movement is perpendicular to the plane of the assay test strip (in other words, no movement along the Z direction / axis). In some embodiments, the limited movement is parallel to the plane of the assay test strip (in other words, no movement in the X or Y direction / axis).

[0045] The sample collection device of the present disclosure may be used to collect droplets, aerosols, or particulates to create a sample of material collected from an object, group, or area. To collect the sample, the surface charge is reduced by wetting the surface. This can be accomplished by the addition of surfactants, wetting agents, surface energy compatible solvents, or by mechanical means. Once the sample is wetted, the collected material may be transported within the fluid for testing.

[0046] In some embodiments, the assay is a lateral flow assay or a vertical flow assay. Generally, a lateral flow assay or a vertical flow assay is a paper-based platform for the detection and quantification of analytes in complex mixtures, where a sample is placed on a test device and the results are displayed within 5-30 minutes. The low development cost and ease of manufacture of lateral flow assays have led to their expansion of application to multiple fields where rapid testing is required. Lateral flow assay-based tests are widely used in hospitals, clinics, and clinical laboratories for the qualitative and quantitative detection of specific antigens and antibodies, as well as products of gene amplification. A variety of biological samples can be tested using the assay.

[0047] Optionally, the sample testing device 150 also includes a visual indicator 170 that informs a user of the presence or absence of viral or pathogenic material in the exhaled airstream that the user provides into the sample collection device 102. The visual indicator may include, for example, a letter, color, word, shape, or line that indicates the presence (or absence) of viral or pathogenic material. The sample testing device 150 may include a viewing window 154 configured to allow visual inspection of at least a portion of the assay 160. In particular, a user may view the test results on the assay 160 through the viewing window and obtain an indication of the presence or absence of pathogens in the eluent and / or test fluid.

[0048] Optionally, the sample testing device 150 may include a barrier (not shown) disposed between the fluidic channel and the assay 160. The barrier may be configured to prevent direct fluid communication between the exhaled airflow and the assay 160 when the sample collection device 102 and sample testing device 150 are attached before a user exhales or introduces the exhaled airflow into the sample collection device 102. The barrier may cover or encapsulate the entire area of ​​the assay 160 and act as a layer between the fluidic channel and the assay 160.

[0049] Test Fluid In some embodiments, the test fluid is an aqueous solution containing a surfactant. In some embodiments, the test fluid may be an aqueous buffer solution. In some embodiments, the test fluid may be saline. In some embodiments, the test fluid may be saline containing a surfactant. In some embodiments, the test fluid may be saline containing about 0.5% to about 2% by weight of a surfactant.

[0050] Media In some embodiments, the porous sample collection medium 112 comprises a nonwoven material. In some embodiments, the nonwoven material (e.g., a nonwoven filtration material) has an electrostatic charge. In some embodiments, the porous sample collection medium 112 comprises a nonwoven filtration material having an electrostatic charge configured to filter pathogens from the exhaled airstream. In some embodiments, the nonwoven filtration material is hydrophobic. Thus, a hydrophobic nonwoven filtration material may be configured to filter pathogens from the exhaled airstream. In some cases, the porous sample collection medium 112 may have a thickness (orthogonal to the major planar surface 114) in the range of 200 micrometers (mm) to 1000 mm, or 250 mm to 750 mm.

[0051] As used herein, the term "hydrophobic" refers to a material that has a water contact angle of 90 degrees or greater, or from about 90 degrees to about 170 degrees, or from about 100 degrees to about 150 degrees. Water contact angles are measured using the ASTM D5727-1997 Standard Test Method for Surface Wettability and Absorbency of Sheet Materials using an automated contact angle tester.

[0052] In some cases, the porous sample collection medium 112 may be formed from a polymeric material. In some cases, the porous sample collection medium 112 may be formed from a polyolefin. In some embodiments, the porous sample collection medium 112 may be formed from a polypropylene. In some embodiments, the porous sample collection medium 112 may be formed from a polylactide (PLA), such as, for example, 6100D from NatureWorks LLC 15305 Minnetonka Blvd Minnetonka, MN 55345. Exemplary nonwoven materials for use in or as the porous sample collection medium 112 include those described in, for example, U.S. Patent Nos. 7,947,142, 8,162,153, 9,139,940, and 10,273,612, all of which are incorporated herein in their entirety.

[0053] In some embodiments, the nonwoven medium is pleated. The sample collection medium itself may be pleated.

[0054] Alternatively, the sample collection device may include a pleating mechanism that creates a pleated pattern or shape in an initially flat or relatively flat sample collection medium 112. One exemplary pleating mechanism is shown in FIGS. 9-12. The pleating mechanism 910 includes a plurality of pleating features, which in this embodiment are ridges 914 and recesses 916. The ridges 136 are in the media holder 130 and the recesses 916 are in the attachment mechanism 140 (although this is merely exemplary and the two may be reversed). As shown in FIGS. 10 and 11, when a relatively flat piece of sample collection medium is placed between the media holder 130 and the attachment mechanism 140 and the two pieces 130 and 140 are pressed firmly together, peaks and valleys (and thus pleats) are formed in the sample collection medium 112. This occurs when the posts 136 press against the sample collection medium 112, causing the sample collection medium 112 to take the shape of the pleated features (e.g., ridges 914 and recesses 916). The posts 136 may also hold the sample collection medium adjacent to the testing device 150.

[0055] In some embodiments, the media holder 130 includes a staging area that holds the sample collection media 112 adjacent to the pleating feature until the attachment feature is attached or pressed adjacent thereto. This is shown in Figures 10 and 11.

[0056] In some embodiments, the media holder 130 and attachment mechanism 140 lock into place to hold the sample collection media 112 in a pleated format. The particular pleating pattern or shape of the pleating features shown in Figures 9-12 is a generally frustoconical pleated shape and / or pattern, although any desired pattern and shape may be used. Additionally, the particular number of ridges 914 and recesses 916 shown in Figures 9A-11 are exemplary and can be modified as needed. For example, the number, size, and spacing of the pleating features may vary based on the size of the sample collection media and / or the height and shape of the conical or cylindrical shape.

[0057] FIG. 12 is a photograph of the sample collection medium 112 in a pleated form.

[0058] 9A-11 also include optional alignment slots 940 and matable alignment tabs 950 that align and mate when the media holder 130 and mounting mechanism 140 are attached to one another. The alignment tabs 950 ensure that the media holder 130 and mounting mechanism are mated or attached such that the ridges 914 and recesses 916 are aligned.

[0059] In some embodiments, the pleat frequency is from about 1 pleat per 0.6 cm of media to about 1 pleat per 2 mm of media, hi some embodiments, the pleat height is from about 2 mm to about 4 mm.

[0060] The pleated sample collection medium offers certain advantages, including increased surface area and improved alignment of the sample collection medium within the sample collection device. The pleating mechanism specifically eliminated any slop in the sample collection medium by forming pleats. This results in better alignment of the sample collection medium and therefore better performance of the sample collection device.

[0061] Pressing Element In some cases, the sample collection device 100 may include a pressing element (not shown) configured to apply pressure onto the loaded porous sample collection medium 112. The pressing element can push remaining test fluid out of the loaded porous sample collection medium 112 for collection and testing.

[0062] Unless otherwise indicated, all numbers expressing feature sizes, quantities and physical properties used in the specification and claims are to be understood as being modified by the term "about." Accordingly, unless specifically indicated to the contrary, the numerical parameters set forth in the above specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by those of ordinary skill in the art utilizing the teachings disclosed herein.

[0063] In the following description, reference is made to the accompanying drawings, which form a part hereof, and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. Accordingly, the following detailed description is not to be taken in a limiting sense.

[0064] As used herein, the term "substantially" has the same meaning as "significantly" and can be understood to modify the term that follows it by at least about 90%, at least about 95%, or at least about 98%.

[0065] The term "about" is used herein in conjunction with numerical values ​​to include normal variations in measurements expected by one of ordinary skill in the art and can be understood to have the same meaning as "about" and to cover typical margins of error, such as ±5% of the stated value.

[0066] 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.

[0067] The terms "a," "an," and "the" are used interchangeably with the term "at least one." The phrase "at least one of," followed by a list, refers to any one of the items in the list, as well as any combination of two or more items in the list.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] Any directions referred to herein, such as "front", "back", "top", "bottom", "left", "right", "upper", "lower", and other directions and orientations, are described herein for clarity with respect to the figures and are not intended to limit the actual device or system or the use of the device or system. A device or system as described herein can be used in several directions and orientations.

[0072] The terms "downstream" and "upstream" refer to relative locations based on the direction of exhaled airflow through the device.

[0073] While specific embodiments have been illustrated and described herein, those skilled in the art will recognize that the specific embodiments illustrated and described may be replaced by various alternative and / or equivalent embodiments without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Accordingly, it is intended that the present disclosure be limited only by the claims and the equivalents thereof.

Claims

1. 1. A sample collection device comprising: a housing extending from a first portion to a second portion, the housing defining a fluid channel from the first portion to the second portion, the first portion configured to receive an exhaled airflow and the second portion configured to be an air outlet portion; a porous sample collection medium having a frusto-conical shape and disposed within the fluid channel, the porous sample collection medium including a nonwoven filter material; a fluid inlet port through which fluid can be introduced into the housing such that the fluid is incident on the porous sample collection medium.

2. a sample testing device comprising an assay, the assay being attached to the sample collection device such that the assay and the porous sample collection medium are adjacent or in direct contact with each other; The sample collection device of claim 1 , further comprising:

3. 3. The sample collection device of claim 2, wherein the sample collection device and the sample testing device can be attached to and / or detached from each other by at least one of snapping, sliding, screwing, clipping, or rotating.

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