Sample collection and analysis system

Abstract

A sample collection system includes a housing including an air inlet configured to receive an exhaled airflow; and a porous sample collection medium, the porous sample collection medium being disposed within the housing; an airflow path extending from the air inlet through the porous sample collection medium; a liquid reservoir in fluid communication with the porous sample collection medium, the liquid reservoir configured to direct a liquid onto the porous sample collection medium, the liquid reservoir comprising: a volume containing the liquid; an opening; and a removable tab, the removable tab sealing the opening; and an assay device configured to receive an eluted sample from the porous sample collection medium. A method of collecting and testing a sample includes flowing exhaled air through a porous sample collection medium to form a captured sample; releasing a metered dose of liquid onto the porous sample collection medium to elute the sample onto an assay device; and observing the test results on the assay device.

Description

Background Art

[0001] Diagnostic tests used to test for the presence of viruses or other pathogens in the airways, throat, or nasopharynx typically involve inserting a swab into the back of the nasal passage, the middle turbinate area of ​​the nasal passage, the anterior nostril, or 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, which is then placed in a container.

[0002] Recently, there has been an unprecedented surge in demand for rapid viral testing due to the COVID-19 pandemic. Control of the outbreak requires a massive expansion of testing for the SARS-CoV-2 virus in several different clinical and epidemiological settings. Until recently, nasopharyngeal (NP) swabs have been the preferred specimen type by the Centers for Disease Control and Prevention (CDC) in the United States, as they are thought to provide the most reliable detection of infection in patients. However, there are conflicting reports regarding which of several specimen types carries the highest viral load.

[0003] However, sensitivity is a complex issue because detection of the upper respiratory tract (nasopharynx and oropharynx) is affected by multiple factors, including the course of illness prior to testing and the limit of detection (LoD) of the RT-PCR assay used. The availability of NP swabs and the resources to establish NP collection sites with specimen collection staff remain key bottlenecks. To address these issues, healthcare systems have adopted a variety of different strategies, including engaging industrial manufacturers to mass produce novel 3D-printed NP swabs, and evaluating different specimen types and alternative specimen collection strategies such as saliva.

[0004] Evaluation of nasal swabs and saliva are rapidly growing areas of interest, particularly because these specimen sample types involve less invasive procedures than NP swabs. As such, patients can self-collect such samples with a simple set of instructions, alleviating the need for trained medical personnel for specimen collection and reducing the use of personal protective equipment (PPE) when supplies are in short supply.

[0005] Many U.S. Food and Drug Administration Emergency Use Authorization (FDA EUA) RT-PCR assays have been approved for use with nasal swabs as a specimen type as well as saliva, but how well these samples perform compared to NP swabs remains unclear. To date, nasal swab studies have shown conflicting results, with some researchers reporting similar test performance to NP swabs and others finding reduced sensitivity.

[0006] Currently available at-home viral tests (e.g., COVID-19 tests) include nasal swabs and test kits (e.g., Ellume TM Test, AbbotTM BinaxNOW TM Testing and Lucira TM Monomer test kits). Tests utilizing nasal swab samples or saliva contend with contaminants that can interfere with various diagnostic tests. Therefore, these sample types require a purification step when using RT-PCR molecular tests.

[0007] There is a need for a simpler and cleaner sample collection and analysis system that allows for easy sample elution in an easy-to-use protocol. In addition, there is a need for a sample collection and analysis system 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. There is also a need for a more precise system that reduces human error and provides more reproducible and reliable test results. Summary of the invention

[0008] There is a need for an inexpensive, simple to use, and reliable sample collection and analysis system that can be used by non-professionals to test for the presence of a target virus, target pathogen, or other target analyte in a collected sample. The sample collection and analysis system may include: a sample collection device for collecting a sample from an exhaled air stream and a test assay for determining the presence or absence of a virus or other pathogen in the collected sample.

[0009] It is desirable to provide a system that includes both a sample collector device and a rapid antigen test in an integrated system. The integrated system can advantageously be self-contained and optionally sterile. Unlike swabs and other test collection devices that may become contaminated when used and / or during testing, a self-contained and sterile system can improve the accuracy and reliability of pathogen testing due to reduced contamination and background noise.

[0010] It would further be desirable to provide a system that remains closed and self-contained after sample collection and optional testing to contain any potential viruses or pathogens and that can be safely disposed of in normal waste collection.

[0011] According to an embodiment, a sample collection and analysis system includes a housing including an air inlet configured to receive an exhaled air flow; a porous sample collection medium disposed within the housing; an airflow path extending from the air inlet through the porous sample collection medium; a liquid reservoir in fluid communication with the porous sample collection medium, the liquid reservoir being configured to direct a liquid onto the porous sample collection medium, the liquid reservoir comprising: a volume that holds the liquid; an opening; and a removable tab that seals the opening; and an assay device configured to receive an eluted sample from the porous sample collection medium. The liquid reservoir may be in close proximity to the air inlet. The liquid reservoir may be at a distance from the air inlet.

[0012] The removable tab may be positioned between the volume and the porous sample collection medium. The removable tab may be a pull tab. The removable tab may include a first portion and a second portion, the first portion being disposed between the volume and the porous sample collection medium, the second portion extending outside the housing and forming a pull tab.

[0013] The porous sample collection medium defines a surface area, and the volume of the liquid reservoir divided by the surface area may be in the range of 10 μL / cm2 to 400 μL / cm2, or 10 μL / cm2 to 250 μL / cm2. The volume may be in the range of 50 μL to 1000 μL. The liquid reservoir may hold 50 μL to 1000 μL of liquid.

[0014] The housing may include a first end and an opposing second end, wherein the air inlet is disposed adjacent the first end, wherein the air outlet is disposed adjacent the second end, and wherein the air flow path extends from the air inlet to the air outlet.The air flow path may extend along a length of the assay device.

[0015] The porous sample collection medium may include a nonwoven filter layer having an electrostatic charge. The nonwoven filter layer is hydrophobic. The liquid may be an aqueous solution containing a surfactant.

[0016] The assay device may be configured to detect the presence of a virus or other pathogen in a collected sample.The assay device may be a lateral flow assay device, a vertical flow assay device, or a colorimetric indicator.

[0017] A method for collecting and testing a sample, the method comprising: flowing exhaled air through a porous sample collection medium disposed within a sample collection device housing to form a captured sample; releasing a metered dose of liquid from a liquid reservoir disposed within the sample collection device housing onto the porous sample collection medium by pulling a pull tab, the metered dose of liquid eluting the captured sample onto an assay device disposed within the sample collection device housing; and observing a test result from the assay device. The flow of exhaled air may include blowing into a nozzle or nosepiece on the sample collection device. Observing the test result includes observing a positive result if a target virus or other target pathogen is present, or observing a negative result if the target virus or other target pathogen is not present.

[0018] The porous sample collection medium is configured to capture samples of viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium can be made of nonwoven material. The nonwoven material can contain polylactic acid, polypropylene or a combination thereof. The nonwoven material can carry an electrostatic charge. The assay device can be a lateral flow assay device or a vertical flow assay device. The assay device is configured to determine the presence or absence of a target virus, pathogen or analyte in the collected sample. The assay device can be configured to display a positive or negative result about the presence of a target virus, pathogen or analyte.

[0019] The assay device may define a strip of material having a length, and wherein the length is parallel to the longitudinal axis of the second portion. The assay device may define a strip of material having a length, and wherein the length is transverse to the longitudinal axis of the second portion.

[0020] According to an embodiment, the kit includes a sample collection and analysis system and instructions for collecting a sample and testing the sample using an assay device. The instructions may include instructions for: exhaling along an airflow path to capture a sample in a porous sample collection medium; moving or removing a removable tab to release a metered dose of liquid onto the porous sample collection medium; and observing the test results in a result display of the assay device. The instructions may also include instructions for reading a test result display of the assay device using an electronic reader. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1A is a top view of a sample collection and analysis system according to an embodiment.

[0022] Figure 1B for Figure 1A Cross-sectional side view of the system.

[0023] Figure 2A for Figure 1A A partial cross-sectional perspective view of the system.

[0024] Figure 2B for Figure 2A A partial cross-sectional perspective view of the system with the pull tab partially removed.

[0025] Figure 2C To combine in Figure 1A A perspective view of a liquid capsule in a sample collection and analysis system.

[0026] Figure 2D for Figure 2C Side view of a liquid capsule.

[0027] Figure 3A For optional pull tab arrangement Figure 1A A top perspective view of a partial cross section of the system.

[0028] Figure 3B for Figure 3A A partial cross-sectional bottom perspective view of the system.

[0029] Figure 4A is a perspective view of a sample collection and analysis system according to an alternative embodiment.

[0030] Figure 4B for Figure 4A Cross-sectional side view of the system.

[0031] Figure 5A for Figure 4A A partial cross-sectional perspective view of the system.

[0032] Figure 5B for Figure 5A A partial cross-sectional perspective view of the system with the pull tab partially removed.

[0033] Fig. 6A is a top view of a sample collection and analysis system according to an embodiment.

[0034] Figure 6B for Fig. 6A Side view of the system.

[0035] Figure 6C for Fig. 6A A cross-sectional perspective view of the system.

[0036] Fig.6D for Fig. 6A A partial cross-sectional side view of the system.

[0037] Fig. 7A for Fig. 6A A perspective view of the bottom portion of the system and the liquid reservoir.

[0038] Figure 7B for Fig. 6A Top view of the bottom part of the system.

[0039] Fig. 8A is a perspective view of a sample collection and analysis system according to an embodiment.

[0040] Figure 8B for Fig. 8A Cross-sectional side view of the system.

[0041] definition

[0042] Unless otherwise indicated, all scientific and technical terms used herein have the meaning commonly used in the art.The definitions provided herein will facilitate understanding of certain terms frequently used herein and are not meant to limit the scope of the present disclosure.

[0043] Unless otherwise indicated, the terms "polymer" and "polymeric material" include, but are not limited to, organic homopolymers, copolymers, such as block, graft, random and syndiotactic copolymers, terpolymers, and the like, as well as blends and modifications thereof. Furthermore, unless expressly limited otherwise, the term "polymer" shall include all possible geometric configurations of the material. These configurations include, but are not limited to, isotactic, syndiotactic and atactic symmetries.

[0044] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of any text that follows the heading, unless so specified.

[0045] The term "ie" is used herein as an abbreviation of the Latin id est and means "that is," while "eg," is used herein as an abbreviation of the Latin phrase exempli gratia and means "for example."

[0046] The term "about" is used herein in conjunction with numerical values ​​to include normal variations in measured values ​​expected by those skilled in the art, and is understood to have the same meaning as "approximately" and to encompass typical margins of error, such as ±5% of the specified value. In addition, unless otherwise indicated, all numerals used in the specification and claims to indicate quantities and all terms indicating directions / orientations (e.g., vertical, horizontal, parallel, perpendicular, etc.) should be understood in all cases as being modified by the term "about".

[0047] Terms such as "a," "an," "the," and "said" are not intended to refer to only a singular entity, but include the general class of which a specific example may be used for illustration.

[0048] The terms "a", "an", "the" and "said" are used interchangeably with the term "at least one". The phrases "at least one of" and "comprising at least one of" followed by a list refer to any one of the items in the list and any combination of two or more items in the list.

[0049] As used herein, the term "or" is generally used in its ordinary sense, including "and / or," unless the context clearly dictates otherwise. The term "and / or" means one or all of the listed elements, or a combination of any two or more of the listed elements.

[0050] Numerical ranges recited by endpoints include 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 10 or less includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). When a range of values ​​is "up to" or "at least" a particular value, that value is included in the range.

[0051] As used herein, "having", "including", "comprising", etc. are used in their open sense and generally mean "including but not limited to". It should be understood that "consisting essentially of", "consisting of", etc. are included in "comprising", etc. As used herein, when "consisting essentially of" refers to a composition, product, method, etc., it means that the constituent elements of the composition, product, method, etc. are limited to the enumerated constituent elements, as well as any other constituent elements that do not materially affect the basic and novel characteristics of the composition, product, method, etc.

[0052] As used herein, the term "substantially" has the same meaning as "significantly" and is understood to modify the following term by at least about 90%, at least about 95%, or at least about 98%. As used herein, the term "substantially not" has the same meaning as "not significantly" and is understood to have the opposite meaning of "substantially", i.e., modifying the following term by no more than 10%, no more than 5%, or no more than 2%.

[0053] The words "preferred" and "preferably" refer to embodiments that may provide certain benefits under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. In addition, 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).

[0054] Any directions referred to herein, such as "front", "back", "top", "bottom", "left", "right", "upper", "lower" and other directions and orientations are described herein with reference to the accompanying drawings for clarity and are not intended to limit the actual device or system or the use of the device or system. The device or system described herein can be used in a variety of directions and orientations.

[0055] Any directions such as "top", "bottom", "left", "right", "upper", "lower" and other directions and orientations mentioned herein are described herein with reference to the accompanying drawings for clarity, but these directions and orientations are not intended to limit the actual device or system or the use of the device or system. The device or system described herein can be used in a variety of directions and orientations.

[0056] The terms "downstream" and "upstream" refer to relative positions based on the direction of exhaled air flow through the device. For example, the most upstream element of the device is the air inlet element, and the most downstream element of the device is the exhaled air outlet element. DETAILED DESCRIPTION

[0057] The present disclosure relates to a sample collection and analysis system. The present disclosure relates to a bioaerosol collection device. The present disclosure further relates to a system including both sample collection and testing capabilities.

[0058] The sample collection and analysis system of the present disclosure includes a sample collection device. The sample collection device includes a porous sample collection medium, which is arranged in a device housing and along an airflow path defined by the device housing. The porous sample collection medium is configured to capture viruses, pathogens or other analytes carried in the exhaled airflow. The system may also include a sample testing assay. A metered dose of liquid passes through the porous sample collection medium and carries away pathogens or viruses that may be bound to the porous sample collection medium to form an eluent. The metered dose of liquid may be arranged in a reservoir arranged in the housing. The eluent may further flow to an assay device and be analyzed using the assay device.

[0059] Specifically, the present disclosure relates to a sample collection device, which includes a housing extending from an air inlet to an air outlet. The housing defines an airflow path from the air inlet to the air outlet. The air inlet is configured to receive an exhaled airflow. A porous sample collection medium is disposed within the housing along the airflow path.

[0060] The housing may include a nozzle or nosepiece or another structure that facilitates breathing into the air inlet. For convenience, reference is made herein to a nozzle, but it should be understood that the structure may also be a nosepiece or other suitable structure. The nozzle may be aligned with the inlet opening. The nozzle may help a user direct the exhaled airflow onto the porous sample collection medium. The nozzle may be integral with the housing or may be removably coupled to the housing.

[0061] A reservoir containing a metered dose of liquid (referred to herein as a liquid reservoir) may be disposed within the housing. The liquid reservoir may be formed by the housing itself, or may be provided as a liquid capsule disposed within the housing. The liquid reservoir may be configured to release a metered dose of liquid onto a porous sample collection medium. The reservoir (e.g., a liquid capsule) may be prepared from any suitable material, such as polyethylene (PE), polypropylene (PP), polyester terephthalate (PET), etc. A removable tab may removably seal the liquid reservoir. The removable tab may be sealed to the opening of the liquid reservoir by a peelable seal. The peelable seal may be formed, for example, by heat sealing, a suitable adhesive, a gasket, or a combination thereof. The removable tab may be composed of a material compatible with the reservoir (e.g., liquid capsule) material. In some embodiments, the removable tab may have a layered construction, wherein the layer contacting the reservoir (e.g., liquid capsule) is made of a material compatible with the reservoir (e.g., liquid capsule) material. The removable tab may also include a barrier layer. For example, the removable tab may include a metallized layer (such as an aluminum layer) to provide a fluid and vapor barrier. Exemplary suitable materials for the removable tab available from 3M Company include 3M 9792R single-coated aluminum; 3M 9793R SC polyolefin; 3M 9794R SC transparent PET; 3M9795R SC advanced polyolefin; 3M 9964SC transparent PET; and 3M 9965 double-coated white PET [2 liners]. Suitable adhesives include adhesives that seal the reservoir so that the liquid does not flow out prematurely but allow the user to remove the tab. In some embodiments, the removable tab has a weaker (or "soft") seal on one or more sides (e.g., on three sides) and a stronger (or "hard") seal on at least one side. This can allow the user to easily peel the tab from the liquid reservoir opening to release the liquid while leaving the tab attached to the device on one side. For example, the peelable seal may have a peel force of 1.81 kgf (4 lbf) or less, or from 0.45 kgf (1 lbf) to 0.9 kgf (2 lbf).The strength of the seal may depend on the material and width of the seal and the design.

[0062] The liquid distributed on the porous sample collection medium may be an aqueous liquid. The liquid may be a buffer solution. The liquid may be an aqueous buffer solution. The liquid may be a saline solution. The liquid may contain a surfactant. "Surfactant" is generally understood to mean a molecule that can be added to a solution to reduce the surface tension of the solution. The liquid may be formulated to have a surface tension that facilitates release from a reservoir and flows through or across a porous sample collection medium and onto an assay device. For example, the surface tension of the liquid may be lower than the surface tension of water. When measured on a porous sample collection medium, the liquid may have a contact angle greater than 90 degrees. The liquid may be a saline solution containing a surfactant. The liquid (e.g., a buffer or saline solution) may contain 0.1% by weight or more or 0.5% by weight or more, and up to 1% by weight or up to 2% by weight of a surfactant. The metered dose of liquid may have a volume of 50 μL or more, 100 μL or more, 150 μL or more, 200 μL or more, or 250 μL or more. A metered dose of liquid may have a volume of 1200 μL or less, 1000 μL or less, 750 μL or less, 500 μL or less, or 400 μL or less. A metered dose of liquid may have a volume of 50 μL to 1000 μL or 100 μL to 500 μL.

[0063] In some embodiments, the system includes two or more liquid reservoirs, each of which is configured to deliver a liquid to a porous sample collection medium. The liquids contained in the two or more liquid reservoirs may be different from each other. For example, one liquid reservoir may contain a buffer solution for eluting the sample, and another liquid reservoir may contain a reagent for analyzing the sample. The liquids from the two or more liquid reservoirs may be released simultaneously or continuously.

[0064] A liquid may be applied to the loaded porous sample collection medium. The liquid may travel 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 present on the loaded porous sample collection medium. The loaded liquid may then be received by an assay device and tested for the presence of viruses, pathogens, or other analytes of interest.

[0065] According to an embodiment, the sample collection and analysis system includes the above-mentioned sample collection device and an assay device configured to receive a metered dose of liquid (e.g., eluent) from the porous sample collection medium. The assay device can be further configured to analyze an analyte of interest, such as a virus, other pathogen, or other analyte. The assay device can be integrated with the sample collection device. The assay device can form an integral element with the housing of the sample collection device.

[0066] The user can exhale into the sample collection device and load the porous sample collection medium with the sample of the exhaled airflow to form a loaded porous sample collection medium. For example, the user can exhale through the air inlet or through the nozzle or nose piece. The housing can be configured so that the exhaled airflow passes through the porous sample collection medium by exhaling through a single opening, air inlet, nozzle or nose piece. The porous sample collection medium is configured to capture viruses, other pathogens or other analytes from the exhaled airflow. Then, the user can release a metered dose of liquid from the liquid reservoir to apply the liquid to the loaded porous sample collection medium and elute the captured sample onto the assay device. The user can use the assay device to test the presence of viruses, pathogens or other analytes in the eluent. The test can be performed when the loaded porous sample collection medium is in place in the sample collection and analysis system.

[0067] According to an embodiment, the sample collection and analysis system forms a single self-contained unit. Providing a self-contained unit allows the sample collection and analysis system to be conveniently shipped and transported and allows for disposal after use. The self-contained unit may have a compact size and may be conveniently carried in a pocket or purse. The self-contained unit may be safely disposed of in normal waste disposal after use.

[0068] The assay device may be a separate element from the sample collection device. The assay device may be configured to be attached to the sample collection device. The sample collection device may include a container for receiving at least a portion of the assay device. The sample collection device may include a container for receiving the entire assay device. The assay device may be a replacement element for the sample collection device.

[0069] Similarly, the liquid capsule can be an element separate from the sample collection device and can be configured to be received by the housing. The housing can include a container (e.g., a reservoir) for receiving the liquid capsule. The liquid capsule can be a replacement element for the sample collection device. An exemplary metered fluid dosage element is commercially available from 3M Company (St. Paul, Minnesota, USA) under the trade name CUROS.

[0070] The assay device included in the sample collection and analysis system can be any suitable assay device. The assay device can be configured to determine the presence or absence of a target virus, pathogen or analyte in the sample collected. In some embodiments, the assay device can be a lateral flow assay device ("LFA"), a vertical flow assay device ("VFA") or a colorimetric indicator. LFA and VFA are typically paper platforms for detecting and quantifying analytes in complex mixtures (including biological samples, such as saliva, urine, etc.). LFA and VFA are typically easy to use and can be used by professionals in health care institutions or laboratories, and can also be used by non-professionals at home. Typically, a liquid sample is placed on an assay device in a sample receiving area and is wicked to a test area along a device by capillary flow. LFA and VFA are typically based on antigens or antibodies, which are fixed in a test area and react selectively with an analyte of interest. The result is typically displayed within 5 to 30 minutes. LFA and VFA can be customized to test a variety of viruses and other pathogens and many other types of analytes. According to an embodiment, the assay device used in the sample collection and analysis system of the present disclosure is configured to detect a target virus, a target pathogen, or other target analyte. According to an embodiment, the assay device used in the sample collection and analysis system of the present disclosure is configured to detect a target virus, a target pathogen, or other target analyte that may be present in the exhaled airflow of a subject.

[0071] Examples of commercially available LFAs that may be included in a sample collection and analysis system include AccessBioCARESTART TM COVID-19 Antigen Home Test, Abbott BINAXNOW TM COVID-19 Antigen Self-Test and Quidel Over-the-counter COVID-19 tests for home use.

[0072] Examples of colorimetric indicators include LFA colorimetric readers that utilize image sensors, such as charge coupled devices (CCDs) or complementary metal oxide semiconductors (CMOSs). Such devices are useful, at least in part, due to their simple construction and small size. When the device is used, the LFA produces a test line that is an aggregate of labeled particles, antigens, and antibodies. The image sensor-based LFA reader acquires an image of the test line and analyzes the pixel intensity of the test line, which varies according to the concentration of the target analyte.

[0073] According to an embodiment, the porous sample collection medium is adapted to allow exhalation through the medium. That is, the porous sample collection medium has sufficient porosity to allow exhalation through the medium. As used herein, the term "porosity" refers to the ratio of the open space in the medium to the amount of volume occupied by the medium material itself. A medium with a high porosity has a larger open space, thus allowing a higher flow rate to be achieved at a lower pressure drop.

[0074] According to the embodiment, the porous sample collection medium is a nonwoven material carrying an electrostatic charge. The electrostatic charge can enable the capture of pathogens, viruses or other analytes from the exhaled airflow. 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, which is configured to capture pathogens, viruses or other analytes from the exhaled airflow. The porous sample collection medium may be a hydrophilic nonwoven material carrying an electrostatic charge, which is configured to capture pathogens, viruses or other analytes from the exhaled airflow. The term "hydrophobic" refers to a material having a water contact angle of 90 degrees or more, or about 90 degrees to about 170 degrees, or about 100 degrees to about 150 degrees. The term "hydrophilic" refers to a material having a water contact angle of less than 90 degrees. Water contact angle is measured using ASTM D5727-1997 standard test method for surface wettability and absorbency of sheeted materials using an automated contact angle tester.

[0075] The porous sample collection medium can be formed of any suitable material that can capture viruses, pathogens or other analytes from the exhaled airflow and release the captured viruses, pathogens or other analytes when in contact with an eluent such as a saline solution. The porous sample collection medium can be formed of a polymer material. The porous sample collection medium can be formed of a polyolefin. Examples of suitable polyolefins include polypropylene, polylactic acid, etc. and combinations thereof. In one embodiment, the porous sample collection medium is formed of polypropylene. In one embodiment, the porous sample collection medium is formed of polylactic acid. An exemplary porous sample collection medium can be commercially available from 3M Company (St. Paul MN, USA) under the trade name FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus AirFilter Merv 13.

[0076] The porous sample collection medium may have a thickness (normal to the main plane) 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 or larger or 2cm 2 or greater (on one side) of the major planar surface area. The porous sample collection medium may have a 3 cm 2 or smaller or 4cm 2 or less. The porous sample collection medium may have a major planar surface area of ​​1 cm 2 Up to 4cm 2 or 2cm 2 Up to 3cm 2 The main plane surface area within the range.

[0077] The housing can be formed of a rigid material (such as plastic) or a paper material (such as cardboard or cardstock). In some embodiments, the housing is made of plastic. The housing can be made of a material that does not absorb any liquid or eluent. For example, the housing can be made of a hydrophobic material. In some embodiments, at least a portion of the housing is transparent. For example, the housing can include a transparent material in the region where the result of the assay device is displayed. The housing can include an observation window (transparent material or opening) in the region where the result is displayed. In some cases, the entire housing can be made of a transparent material. The housing can also include a cover or sealing layer configured to prevent contamination before or after using the system. The cover or sealing layer can be removable (for example, can be removed before use). The cover or sealing layer can be closable and / or reclosable (for example, can be closed after use).

[0078] The housing may include a pre-filter or screen disposed in the airflow path in front (upstream) of the porous sample collection medium. The screen may be configured to capture larger particles (larger than viruses or pathogens) and prevent these particles from reaching the porous sample collection medium. The exhaled airflow passes through the thickness of the pre-filter or screen. The pre-filter or filter at least partially blocks the air flow path. In some cases, the pre-filter or screen may have a main plane, which is orthogonal 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, which is configured to filter out larger particles from the exhaled airflow passing through the pre-filter element or screen. In some cases, the pre-filter or screen may be a non-woven layer without static charge. In some embodiments, the pre-filter or screen does not capture a significant amount of viral material, pathogen material or other analyte material, but allows them to be transmitted through the pre-filter or screen. In some embodiments, the pre-filter or screen is made of or includes at least one of: a plastic mesh, a woven mesh, a needled fiber mesh, a knitted mesh, an extruded web, and / or a carded or spunbond cover.

[0079] Reference now Figures 1A to 2B , shows an illustrative example of a sample collection and analysis system 1. According to an embodiment, the system 1 includes both sample collection and testing capabilities. Figures 1B to 2B is shown with the bottom cover removed to better illustrate the internal components. Figure 1A and Figure 1B As can be seen, the system 1 has a housing 100 extending from a first end 101 to a second end 102. The housing 100 has an air inlet 131 configured to receive an exhaled airflow. The air inlet 131 may be provided as part of the nozzle 130, as shown. Alternatively, the housing 100 may include a nosepiece or another structure associated with the air inlet 131. A porous sample collection medium 120 is disposed within the housing. The housing 100 defines an airflow path 110 extending from the air inlet 131 and passing through the porous sample collection medium 120. The porous sample collection medium 120 is constructed and arranged to capture viruses, other pathogens, or other analytes from the exhaled airflow flowing through the airflow path 110.

[0080] According to an embodiment, the porous sample collection medium 120 at least partially blocks the airflow path 110. The porous sample collection medium 120 may completely block the airflow path. The exhaled airflow may pass through the thickness of the porous sample collection medium 120. The porous sample collection medium 120 may have a major plane that is orthogonal to the direction of the exhaled airflow passing through the thickness of the porous sample collection medium 120.

[0081] The porous sample collection medium 120 may be a nonwoven material that is configured to filter viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium 120 may be a nonwoven material with an electrostatic charge that is configured to filter viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium 120 may be a hydrophobic nonwoven material that is configured to filter viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium 120 may be a hydrophobic nonwoven material that is configured to filter viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium 120 may be a hydrophobic nonwoven material with an electrostatic charge that is configured to filter viruses, pathogens or other analytes from the exhaled airflow. The porous sample collection medium 120 may be formed by a polymer material. Suitable materials for the porous sample collection medium 120 are discussed above.

[0082] The porous sample collection medium 120 may have a thickness (normal to the major plane) in the range of 200 μm to 1000 μm or 250 μm to 750 μm. The porous sample collection medium 120 may have a thickness of about 1 cm 2 To about 4cm 2 or about 2cm 2 About 3cm 2 The main plane surface area within the range.

[0083] The housing 100 also includes a liquid reservoir 200. According to an embodiment, the liquid reservoir 200 has a volume V200 for accommodating a metered dose of liquid 201 for eluting a sample captured by the porous sample collection medium 120. The liquid reservoir 200 can be in fluid communication with (e.g., adjacent or proximate to) the porous sample collection medium 120 so that when the liquid 201 is released from the liquid reservoir 200, it can flow onto the porous sample collection medium 120. The liquid reservoir 200 defines an opening 220 that can be removably sealed by a removable tab 250. The removable tab 250 is positioned between the opening 220 and the porous sample collection medium 120.

[0084] In the illustrated embodiment, the liquid reservoir 200 overlaps the porous sample collection medium 120. Alternatively, the liquid reservoir 200 may be in fluid communication with (e.g., adjacent or proximate to) the porous sample collection medium 120, such that liquid 201 from the liquid reservoir 200 flows onto the porous sample collection medium 120. The system 1 may be provided with an additional wicking pad arranged to wick the liquid 201 from the open liquid reservoir 200 to the porous sample collection medium 120.

[0085] exist Figures 1A to 2B In the illustrated embodiment, the liquid reservoir 200 is formed as part of the nozzle 130. The nozzle 130 may be formed by a hollow ring 132 surrounding the air inlet 131. The liquid reservoir 200 may be formed in a flared portion of the hollow ring 132.

[0086] The liquid reservoir 200 may include a capsule 210 containing a liquid 201 disposed within the liquid reservoir 200. The volume V200 of the liquid reservoir 200 may be defined by the capsule 210. The liquid 201 may be dispensed into the capsule 210 and the capsule 210 may be removably sealed with a tab 250. That is, rather than being directly sealed to the housing 100, the tab 250 may be sealed to the capsule 210. The sealed capsule 210 may be placed within the liquid reservoir 200 and the system 1 may be assembled. The capsule 210 may be shaped to closely engage the interior of the liquid reservoir 200 formed on the housing 100 and follow its contours. The capsule 210 may include a lip 211. The liquid reservoir 200 or the housing 100 may contain corresponding mating features (such as protrusions or detents) to facilitate coupling the liquid capsule 210 with the liquid reservoir 200. The lip 211 may facilitate sealing the tab 250 to the capsule 210.

[0087] The removable tab 250 includes a first portion 251 and a second portion 257. The first portion 251 can be a sealing portion disposed against (e.g., sealed to) the lip 211 (or to the opening 220 if the system 1 does not include a capsule 210). The first portion 251 can be folded over itself and can include a fold 252, such as Figure 2A The second portion 257 may extend from the housing 100 and may form a pull tab. The user may pull the second portion 257 to slide the tab 250 at least partially from between the liquid reservoir 200 (e.g., the capsule 210) and the porous sample collection medium 120, as shown. Figure 2B As shown. The peel angle of the pull tab may be, for example, between 30 and 180 degrees. Pulling the second portion 257 may unseal and at least partially expose the opening 220 to allow the liquid 201 to flow (arrow 202) onto the porous sample collection medium 120. Folding the removable pull tab 250 allows the pull tab to be simply pulled rather than sheared. The removable tab 250 may be sealed to the liquid reservoir 200, for example, by heat sealing, a suitable adhesive, a gasket, or a combination thereof.

[0088] Alternatively, the liquid 201 may be disposed directly in the liquid reservoir 200. In such an embodiment, the opening of the liquid reservoir 200 is sealed by the tab 250.

[0089] The liquid reservoir 200 and / or the capsule 210 may be formed to facilitate the flow of liquid from the liquid reservoir 200 and / or the capsule 210. For example, the capsule 210 may have a height to width ratio that facilitates (e.g., does not interfere with) the flow of liquid. Figure 2C and Figure 2DAs shown, the capsule 210 has a height H210 and a width W210. The height H210 may be the vertical dimension when the system 1 is held horizontally, for example, the length of the housing 100 is held in a horizontal orientation, wherein the airflow inlet 131 faces upward. The height H210 may be the maximum height of the interior of the capsule 210. The width W210 may be the horizontal dimension orthogonal to the vertical dimension. The width W210 may be the maximum width of the interior of the capsule 210 from the sidewall to the opposite sidewall. The liquid reservoir and / or the capsule 210 may also have a length L210 orthogonal to both the height H210 and the width W210. At least one or preferably both of the width W210 and the length L210 are greater than the height H210. The ratio of the height H210 (horizontal dimension) to the width W210 (vertical dimension) may be 1 or less, 0.9 or less, 0.8 or less, or 0.75 or less. The ratio of the height H210 to the width W210 may be 0.3 or more, 0.4 or more, or 0.5 or more. The ratio of the height H210 to the width W210 may be 0.5 to 0.75.

[0090] The sidewall 212 facing the second end 102 of the housing may be angled or faceted and include a protrusion 213 extending toward the second end 102 of the housing. The protrusion 213 helps reduce the peeling force required to peel off the removable tab 250. The protrusion 213 also provides controlled release of a metered dose of liquid as the opening size gradually increases from the protrusion 213.

[0091] The system 1 also includes an assay device 300 disposed within the housing 100 and configured to receive an eluted sample from the porous sample collection medium 120. According to an embodiment, the assay device 300 is in direct contact with the porous sample collection medium 120. For example, a portion of the assay device 300 may overlap with the porous sample collection medium 120, such as Figures 1B to 2B As shown. Liquid 201 with eluted sample can be wicked from porous sample collection medium 120 to sample receiving area 310 of assay device 300. Eluted sample can be further wicked to test area 320. Assay device 300 can be a flow assay device, such as a lateral flow assay device or a vertical flow assay device. Assay device 300 can be configured to detect viruses or other pathogens or analytes. Assay device 300 can include a test result display 370 to indicate the presence or absence of viruses or other pathogens or analytes. Housing 100 can include a corresponding result observation window 170, through which the test result display 370 can be observed.

[0092] In some embodiments, the volume of the metered dose of liquid 201 is proportional to the surface area of ​​the porous sample collection medium 120. The porous sample collection medium 120 defines a major surface area, and the metered dose of liquid 201 defines a volume, and the volume divided by the surface area can be 10 μL / cm2 Up to 400 μL / cm 2 , or 10 μL / cm 2 Up to 250 μL / cm 2 , or 50 μL / cm 2 Up to 150 μL / cm 2 In some embodiments, the metered dose of liquid 201 defines a volume in the range of 50 μL to 1000 μL or 100 μL to 500 μL.

[0093] The liquid 201 dispensed from the liquid reservoir 200 may be an aqueous liquid. The liquid 201 may be an aqueous buffer solution. The liquid 201 may be an aqueous liquid with a surfactant. The liquid 201 may be a saline solution. The liquid 201 may be a saline solution containing a surfactant. The liquid 201 may be a saline solution containing 0.5 wt % to 2 wt % of a surfactant.

[0094] In some embodiments, the tab 250" may include perforations 255 to facilitate removal of the tab 250", rather than folding over on itself, such as FIG. 3A to FIG. 3B The system is shown in Figure 3B 2 is shown with the bottom cover removed to better illustrate the internal components. The perforated tab 250" includes a first portion 251" and a second portion 257". The first portion 251" may form a sealing portion and seal to the capsule 210'. Although the perforated tab 250" is shown with Figure 1A to Figure 1B 1, but it can also be used with other configurations of liquid reservoirs (such as FIG. 4A to FIG. 5B The first portion 251" may be directly sealed to the liquid reservoir 200'. The perforations 255 may be placed around the opening 220 along the periphery of the first portion 251". When the user pulls the second portion 257" (pull tab), the pull tab 250" separates along the perforations 255 to release the liquid 201 in the liquid reservoir 200 (e.g., capsule 210').

[0095] In another embodiment, FIG. 4A to FIG. 5B As shown, the liquid reservoir 200' is located a certain distance away from the air inlet 131 (eg, nozzle 130). Figure 5A and Figure 5B , with its bottom cover removed to better illustrate the internal components. The liquid reservoir 200' may be connected to the airflow path 110' via a channel 230. The channel 230 may facilitate wicking or flow of the liquid 201 from the liquid reservoir 200' to the porous sample collection medium 120'.

[0096] In the embodiment shown, the liquid 201 is disposed directly in the liquid reservoir 200' formed by the housing 100' (excluding the capsule). The liquid reservoir 200' is sealed by the tab 250'. The liquid reservoir 200' is surrounded by a sealing groove 260. The first portion 251' of the tab may form a sealing portion and seal against the sealing groove 260. The tab 250' may be folded against itself along the fold 252'. The second portion 257' of the tab extends from the housing 100'. The second portion 257' may form a pull tab.

[0097] In the illustrated embodiment, the wicking pad 124 is arranged to wick the liquid 201 from the open liquid reservoir 200' to the porous sample collection medium 120'. The wicking pad 124 can be positioned directly adjacent to (e.g., below) the liquid reservoir 200'. The wicking pad 124 can extend from below the liquid reservoir 200' to the porous sample collection medium 120'.

[0098] The rest of the system 1' can be similar to reference Figures 1A to 2B The system 1.

[0099] In some embodiments, the airflow channel 1110 extends longitudinally through the sample collection and analysis system 1000, such as FIG. 6A to FIG. 7B The system 1000 includes a housing 1100 having a first end 1101 and a second end 1102 opposite to each other, and an air flow inlet 1131 in a nozzle 1130. A porous sample collection medium 1120 and an assay device 1300 are disposed within the housing 1100. The housing includes a liquid reservoir 1200, which may be similar to Figure 1A The liquid reservoir 200 of the system 1, or alternatively similar to Figure 4A The liquid reservoir 200' of the system 1' of FIG. 1 . The removable tab 1250 can be used to removably seal the liquid reservoir 1200. The assay device 1300 can include a test result display 1370 that can be viewed through a result viewing window 1170 in the housing 1100.

[0100] The airflow channel 1110 may extend from the airflow inlet 1131 to the airflow outlet 1610. The airflow inlet 1131 may be located near or adjacent to the first end 1101. The airflow outlet 1610 may be located near or adjacent to the second end 1102. The airflow channel 1110 may extend along the length of the testing device 1300. The exhaled airflow 1112 may flow through the airflow inlet 1131, along the airflow channel 1110, and through the airflow outlet 1610. The housing 1100 may include a cavity 1640 adjacent to the airflow inlet 1131. The cavity 1640 may be formed below the porous sample collection medium 1120, such as Fig.6DThe cavity 1640 may be in fluid communication with a channel 1630 extending along the length of the housing 1100. The channel 1630 may also accommodate the assay device 1300. The channel 1630 is further in fluid communication with the airflow outlet 1610.

[0101] The housing 1100 may be formed of two parts, a first part 1150 and a second part 1600. The first part 1150 may be a top part, and the second part 1600 may be a bottom part. The airflow channel 1110 may be formed between the first part 1150 and the second part 1600. The second part 1600 may include features that form a cavity 1640, a channel 1630, and an outlet 1610. For example, the second part 1600 may include a frame 1670 that facilitates such features. The second part 1600 may also include features that facilitate coupling the second part 1600 to the first part 1150, such as a protrusion 1680.

[0102] In the illustrated embodiment, the second portion 1600 includes two holes for the airflow outlet 1610. However, any number of holes may be used, such as 1, 2, 3, 4, 5, etc. The number and size of the holes can be used to adjust the resistance to flow through the airflow channel 1110.

[0103] The housing 1100 may also be configured to facilitate containing a liquid capsule 1210 including a metered dose of liquid 1201. When the housing 1100 is held horizontally, for example, when the length of the housing 1100 is held in a horizontal orientation and the airflow inlet 1131 faces upward, the opening 1220 of the liquid capsule 1210 may be positioned below the horizontal plane of the porous sample collection medium 1120. This may help control the flow of liquid from the liquid capsule 1210 to the porous sample collection medium 1120 and elute the captured sample from the porous sample collection medium 1120 to the assay device sample receiving area 1310. For example, positioning the liquid capsule 1210 below the horizontal plane of the porous sample collection medium 1120 may allow the liquid to wick through rather than flood the porous sample collection medium 1120.

[0104] The housing 1100 may also include a liquid flow control feature 1620, such as a raised or recessed feature positioned below the liquid capsule 1210. In an exemplary embodiment, the feature 1620 includes a plurality of grooves 1621, such as Figure 7B As shown. The groove 1621 can be oriented in the desired liquid flow direction, i.e., toward the porous sample collection medium 1120 and the assay device sample receiving area 1310. Other shapes are also possible, such as raised dimples, lines, or other shapes. The porous sample collection medium 1120 can be partially disposed on the liquid flow control feature 1620, and the liquid capsule 1210 can be disposed on top of the porous sample collection medium 1120.

[0105] The liquid capsule 1210 can be separated from the porous sample collection medium 1120 by a removable tab 1250. The removable tab 1250 may include a first portion 1251 and a second portion 1257. The first portion 1251 may be a sealing portion disposed against (e.g., sealed to) the lip 1211 of the liquid capsule 1210. The first portion 1251 may be folded over itself and may include a fold 1252, such as Fig.6D The second portion 1257 can extend from the housing 1100 and can form a pull tab.

[0106] The first portion 1150 and the second portion 1600 can be connected by any suitable mechanism, such as a snap-fit ​​closure, a friction fit, an adhesive, a heat seal, etc. In some embodiments, the first portion 1150 and the second portion 1600 can be connected by a tamper-resistant connection. Other possible tamper-indicating features include colored dyes that indicate user or tampering, or breakpoints that indicate to the user whether the device has been used or tampered with (e.g., perforations, thin walls, torque-breaking plastic portions, and / or spring-like designs).

[0107] Fig. 8A and Figure 8B An alternative embodiment of a sample collection and analysis system 2000 is shown, in which a liquid reservoir 2200 is provided as a separate element to be received by a housing 2100. The system 2000 has a housing 2100 extending from a first end 2101 to a second end 2102. The housing 2100 has an air inlet 2131 configured to receive an exhaled airflow. As shown, the air inlet 2131 may be provided as part of a nozzle 2130, or alternatively provided as a nosepiece. A porous sample collection medium 2120 is disposed within the housing. The housing 2100 defines an airflow path 2110 extending from the air inlet 2131 and passing through the porous sample collection medium 2120. The porous sample collection medium 2120 is constructed and arranged to capture viruses, other pathogens, or other analytes from the exhaled airflow flowing through the airflow path 2110. The system 2000 also includes an assay device 2300 disposed within the housing 2100 and configured to receive an eluted sample from the porous sample collection medium 2120. The assay device 2300 may include a test result display 2370 to indicate the presence or absence of a virus or other pathogen or analyte. The housing 2100 may include a corresponding result viewing window 2170 through which the test result display 2370 may be viewed.

[0108] The liquid reservoir 2200 may include a capsule 2210 containing a metered dose of liquid. The liquid reservoir 2200 may also include a handle 2240 for convenient use and placement of the liquid reservoir 2200. The liquid reservoir 2200 may be received in the air inlet 2131 (e.g., nozzle 2130) of the housing 2100. The housing 2100 may include a mesh or screen 2122 disposed within the air inlet 2131. The screen 2122 may be in the air flow path 2110 and cover the porous sample collection medium 2120. The screen 2122 may be used as a pre-filter and a surface against which the liquid reservoir 2200 may be pressed to break, pierce, peel or otherwise break the seal on the capsule 2210 to release the metered dose of liquid. The user may hold the handle 2140 and place the capsule 2210 into the air inlet 2131. The user may then twist and / or press the capsule 2210 against the screen 2122 to release a metered dose of liquid onto the porous sample collection medium.

[0109] The sample collection and analysis system 2000 may also include a removable and replaceable airflow outlet cover 2164. The airflow outlet cover 2164 may be removed by a user from the bottom portion 2160 of the housing 2100 to provide an airflow outlet in the bottom portion 2160. Once the metered dose of liquid is applied to the porous sample collection medium 2120, the user may further replace the airflow outlet cover 2164 to close the opening and prevent the liquid from flowing through the opening. Although the airflow outlet cover 2164 is shown as a separate piece, the airflow outlet cover 2164 may be connected to the bottom portion 2160. For example, the airflow outlet cover 2164 may be pivotally, slidably, hingedly, or releasably connected to the bottom portion 2160.

[0110] The screen 2122, the airflow outlet cover 2164, or both may optionally be incorporated into any of the embodiments discussed herein, including Figure 1A , Figure 4A and Fig. 6A Those embodiments shown.

[0111] The sample collection and analysis systems discussed herein may include an area for writing or otherwise indicating identifying information (such as name, initials, account number, etc.).

[0112] The sample collection and analysis system may also include a machine-readable optical label. Such labels may include, for example, a barcode and a QR (quick response) code. The machine-readable optical label may be configured to display the results of the assay device. The machine-readable optical label may be used to read and record the results. An electronic reader capable of reading the machine-readable optical label may be used to read and record the results. The electronic reader may be, for example, a smart phone, a tablet computer, a laptop computer, or a barcode reader or a QR code reader. The electronic reader may also be used to transmit the results to, for example, a healthcare provider or a database.

[0113] A method of using a sample collection and analysis system may include: exhaling into an air inlet (e.g., into a nozzle) to capture a sample in a porous sample collection medium, thereby forming a loaded porous sample collection medium; at least partially removing (or moving) a removable tab to release a metered dose of liquid onto the porous sample collection medium, thereby eluting the sample from the loaded porous sample collection medium, and allowing the eluted sample to flow onto an assay device; and observing a test result in a result display of the assay device. The method may also include reading a result display of the assay device using an electronic reader.

[0114] The sample collection and analysis system may be provided as a kit. The kit may include a sample collection and analysis system as discussed above and instructions for collecting a sample and testing the sample using the assay device. The instructions may include instructions for: exhaling along an airflow path to capture a sample in a porous sample collection medium; moving or removing a removable tab to release a metered dose of liquid onto the porous sample collection medium; and observing the test results in a result display of the assay device. The instructions may also include instructions for reading a test result display of the assay device using an electronic reader.

[0115] Implementation

[0116] The following is a list of exemplary embodiments according to the present disclosure.

[0117] Embodiment 1 is a sample collection system, which includes: a shell, the shell including an air inlet configured to receive an exhaled air flow; a porous sample collection medium, the porous sample collection medium being disposed in the shell; an air flow path, the air flow path extending from the air inlet through the porous sample collection medium; a liquid reservoir, the liquid reservoir being fluidically connected to the porous sample collection medium, the liquid reservoir being configured to direct liquid onto the porous sample collection medium, the liquid reservoir including: a volume, the volume accommodating the liquid; an opening; and a removable tab, the removable tab sealing the opening; and an assay device, the assay device being configured to receive an eluted sample from the porous sample collection medium.

[0118] Embodiment 2 is a sample collection system according to embodiment 1, wherein the liquid reservoir is adjacent to the air inlet.

[0119] Embodiment 3 is a sample collection system according to embodiment 1 or 2, wherein the liquid reservoir is a distance away from the air inlet.

[0120] Embodiment 4 is a sample collection system according to embodiment 3, further comprising a liquid flow channel extending between the liquid reservoir and the porous sample collection medium.

[0121] Embodiment 5 is a sample collection system according to any preceding embodiment, wherein the removable tab is positioned between the volume and the porous sample collection medium.

[0122] Embodiment 6 is a sample collection system according to any preceding embodiment, wherein the removable tab is a pull tab.

[0123] Embodiment 7 is a sample collection system according to any of the preceding embodiments, wherein the removable tab comprises a first portion and a second portion, the first portion being disposed between the volume and the porous sample collection medium, the second portion extending outside the housing and forming a pull tab.

[0124] Embodiment 8 is a sample collection system according to embodiment 7, wherein the first portion includes a folded portion.

[0125] Embodiment 9 is a sample collection system according to embodiment 7, wherein the first portion is adhered to the liquid reservoir by a heat seal, an adhesive, a gasket, or a combination thereof.

[0126] Embodiment 10 is a sample collection system according to any preceding embodiment, wherein the removable tab comprises a perforation forming a breakpoint.

[0127] Embodiment 11 is a sample collection system according to any of the preceding embodiments, wherein the porous sample collection medium defines a surface area, and the volume of the liquid reservoir divided by the surface area ranges from 10 μL / cm2 to 400 μL / cm2, or from 10 μL / cm2 to 250 μL / cm2, or from 50 μL / cm2 to 150 μL / cm2.

[0128] Embodiment 12 is a sample collection system according to any preceding embodiment, wherein the volume is in the range of 50 μL to 1000 μL.

[0129] Embodiment 13 is a sample collection system according to any of the preceding embodiments, wherein the liquid reservoir holds 50 μL to 1000 μL of the liquid. The metered dose of liquid may have a volume of 50 μL or more, 100 μL or more, 150 μL or more, 200 μL or more, or 250 μL or more. The metered dose of liquid may have a volume of 1200 μL or less, 1000 μL or less, 750 μL or less, 500 μL or less, or 400 μL or less. The metered dose of liquid may have a volume of 50 μL to 1000 μL or 100 μL to 500 μL.

[0130] Embodiment 14 is a sample collection system according to any of the preceding embodiments, wherein the liquid reservoir has a horizontal dimension and a vertical dimension, wherein the horizontal dimension is parallel to the porous sample collection medium and the vertical dimension is orthogonal to the horizontal dimension, wherein the horizontal dimension is no more than 1 times the vertical dimension. The ratio of height (horizontal dimension) to width (vertical dimension) can be 1 or less, 0.9 or less, 0.8 or less, or 0.75 or less. The ratio of height to width can be 0.3 or more, 0.4 or more, or 0.5 or more. The ratio of height to width can be 0.5 to 0.75.

[0131] Embodiment 15 is a sample collection system according to any of the preceding embodiments, wherein the shell includes a first end and an opposite second end, wherein the air inlet is arranged adjacent to the first end, wherein the air outlet is arranged adjacent to the second end, and wherein the air flow path extends from the air inlet to the air outlet.

[0132] Embodiment 16 is a sample collection system according to embodiment 15, wherein the airflow path extends along the length of the testing device.

[0133] Embodiment 17 is a sample collection system according to any preceding embodiment, wherein the housing includes a first portion coupled to a second portion, wherein the air inlet is formed in the first portion.

[0134] Embodiment 18 is a sample collection system according to embodiment 17, wherein the first part and the second part are connected by a snap-fit ​​closure, and optionally wherein the snap-fit ​​closure is tamper-resistant.

[0135] Embodiment 19 is a sample collection system according to any preceding embodiment, wherein the porous sample collection medium comprises a nonwoven filter layer having an electrostatic charge.

[0136] Embodiment 20 is a sample collection system according to embodiment 19, wherein the nonwoven filter layer is hydrophobic.

[0137] Embodiment 21 is a sample collection system according to any preceding embodiment, wherein the liquid is an aqueous solution comprising a surfactant.

[0138] Embodiment 22 is a sample collection system according to any of the preceding embodiments, comprising two or more liquid reservoirs, each liquid reservoir being configured to deliver a liquid to the porous sample collection medium, optionally wherein at least one of the two or more liquid reservoirs contains a liquid different from the liquid contained in another of the two or more liquid reservoirs.

[0139] Embodiment 23 is a sample collection system according to any of the preceding embodiments, further comprising a pre-filter, the pre-filter being fixed within the housing and along the air flow path and located between the air inlet and the porous sample collection medium.

[0140] Embodiment 24 is a sample collection system according to any of the preceding embodiments, wherein the assay device is configured to detect the presence of a virus or other pathogen in the collected sample.

[0141] Embodiment 25 is a sample collection system according to any preceding embodiment, wherein the assay device is a lateral flow assay device, a vertical flow assay device, or a colorimetric indicator.

[0142] Embodiment 26 is a sample collection system according to any of the preceding embodiments, wherein the housing comprises a test result display window.

[0143] Embodiment 27 is a method for collecting and testing samples, the method comprising: allowing exhaled air to flow through a porous sample collection medium to form a captured sample, the porous sample collection medium being disposed in a sample collection device housing; releasing a metered dose of liquid from a liquid reservoir disposed in the sample collection device housing onto the porous sample collection medium by pulling a pull tab, the metered dose of liquid eluates the captured sample onto a testing device disposed in the sample collection device housing; and observing the test results of the testing device.

[0144] Embodiment 28 is a method according to embodiment 27, wherein pulling the pull tab unseals the opening on the liquid reservoir.

[0145] Embodiment 29 is a method according to embodiment 27 or 28, wherein the metered dose comprises 50 μL to 1000 μL of buffer. The metered dose of liquid may have a volume of 50 μL or more, 100 μL or more, 150 μL or more, 200 μL or more, or 250 μL or more. The metered dose of liquid may have a volume of 1200 μL or less, 1000 μL or less, 750 μL or less, 500 μL or less, or 400 μL or less. The metered dose of liquid may have a volume of 50 μL to 1000 μL or 100 μL to 500 μL.

[0146] Embodiment 30 is a method according to any one of embodiments 27 to 29, wherein flowing the exhaled air comprises blowing into a nozzle on the sample collection device.

[0147] Embodiment 31 is a method according to any one of embodiments 27 to 29, wherein flowing the exhaled air comprises blowing into a nosepiece on the sample collection device.

[0148] Embodiment 32 is a method according to any one of embodiments 27 to 31, wherein observing the test result includes observing a positive result if the target virus or other target pathogen is present, or observing a negative result if the target virus or other target pathogen is not present.

[0149] Embodiment 33 is a method according to any one of embodiments 27 to 32, further comprising reading a QR code on the sample collection device.

[0150] All references and publications cited herein are expressly incorporated by reference in their entirety into the present disclosure, except for the contents that they may directly conflict with the present disclosure. Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that the specific embodiments shown and described may be replaced by a variety of alternative and / or equivalent implementations without departing from the scope of the present disclosure. It should be understood that the present disclosure is not intended to be improperly limited by the exemplary embodiments and examples shown herein, and such embodiments and examples are presented only by way of example, and the scope of the present disclosure is intended to be limited only by the claims set forth below herein.

Claims

1. A sample collection system, comprising: a housing comprising an air inlet configured to receive an exhaled flow of air; a porous sample collection medium, wherein the porous sample collection medium is disposed within the housing; an air flow path extending from the air inlet through the porous sample collection medium; a liquid reservoir in fluid communication with the porous sample collection medium, the liquid reservoir being configured to direct liquid onto the porous sample collection medium, the liquid reservoir comprising: a volume, the volume containing the liquid; Opening; and a removable tab that seals the opening; and An assay device is configured to receive an eluted sample from the porous sample collection medium.

2. The sample collection system of claim 1, wherein the liquid reservoir is proximate to the air inlet.

3. A sample collection system according to claim 1 or 2, wherein the liquid reservoir is located a distance from the air inlet. 4 . The sample collection system of claim 3 , further comprising a liquid flow channel extending between the liquid reservoir and the porous sample collection medium.

5. The sample collection system of any preceding claim, wherein the removable tab is positioned between the volume and the porous sample collection medium.

6. The sample collection system according to any preceding claim, wherein the removable tab is a pull tab.

7. The sample collection system of any preceding claim, wherein the removable tab comprises a first portion disposed between the volume and the porous sample collection medium and a second portion extending outside the housing and forming a pull tab. The sample collection system of claim 7 , wherein the first portion comprises a folded portion.

9. The sample collection system of claim 7, wherein the first portion is adhered to the liquid reservoir by a heat seal, an adhesive, a gasket, or a combination thereof.

10. The sample collection system of any preceding claim, wherein the removable tab comprises a perforation forming a breakpoint.

11. A sample collection system according to any preceding claim, wherein the porous sample collection medium defines a surface area and the volume of the liquid reservoir divided by the surface area is in the range of 10 μL / cm 2 Up to 400 μL / cm 2 , or 10 μL / cm 2 Up to 250 μL / cm 2 .

12. The sample collection system of any preceding claim, wherein the volume is in the range of 50 μL to 1000 μL.

13. The sample collection system of any preceding claim, wherein the liquid reservoir holds 50 μL to 1000 μL of the liquid.

14. The sample collection system of any preceding claim, wherein the liquid reservoir has a horizontal dimension and a vertical dimension, the horizontal dimension being parallel to the porous sample collection medium and the vertical dimension being orthogonal to the horizontal dimension, wherein the horizontal dimension is no more than 1 times the vertical dimension.

15. A sample collection system according to any preceding claim, wherein the housing includes a first end and an opposing second end, wherein the air inlet is disposed adjacent to the first end, wherein the air outlet is disposed adjacent to the second end, and wherein the air flow path extends from the air inlet to the air outlet.

16. The sample collection system of claim 15, wherein the airflow path extends along a length of the assay device.

17. The sample collection system of any preceding claim, wherein the housing comprises a first portion coupled to a second portion, wherein the air inlet is formed in the first portion.

18. The sample collection system of claim 17, wherein the first portion and the second portion are connected by a snap-fit ​​closure, and optionally wherein the snap-fit ​​closure is tamper-resistant.

19. The sample collection system of any preceding claim, wherein the porous sample collection medium comprises a nonwoven filter layer having an electrostatic charge.

20. The sample collection system of claim 19, wherein the nonwoven filter layer is hydrophobic.

21. The sample collection system of any preceding claim, wherein the liquid is an aqueous solution comprising a surfactant.

22. A sample collection system according to any of the preceding claims, wherein the sample collection system comprises two or more liquid reservoirs, each liquid reservoir being configured to deliver a liquid to the porous sample collection medium, optionally wherein at least one of the two or more liquid reservoirs contains a liquid different from the liquid contained in another of the two or more liquid reservoirs.

23. The sample collection system of any preceding claim, further comprising a pre-filter secured within the housing and along the air flow path and located between the air inlet and the porous sample collection medium.

24. The sample collection system of any preceding claim, wherein the assay device is configured to detect the presence of a virus or other pathogen in a collected sample.

25. The sample collection system of any preceding claim, wherein the assay device is a lateral flow assay device, a vertical flow assay device, or a colorimetric indicator.

26. The sample collection system of any preceding claim, wherein the housing comprises a test result display window.

27. A method for collecting and testing a sample, the method comprising: flowing exhaled air through a porous sample collection medium disposed within a sample collection device housing to form a captured sample; releasing a metered dose of liquid from a liquid reservoir disposed in the sample collection device housing onto the porous sample collection medium by pulling a pull tab, the metered dose of liquid eluting the captured sample onto an assay device disposed in the sample collection device housing; as well as Observe the test results on the assay device.

28. The method of claim 27, wherein pulling the pull tab unseals the opening in the liquid reservoir.

29. The method of claim 27 or 28, wherein the metered dose comprises 50 μL to 1000 μL of buffer.

30. The method of any one of claims 27 to 29, wherein flowing exhaled air comprises blowing into a nozzle or nosepiece on the sample collection device.

31. The method of any one of claims 27 to 30, wherein observing the test result comprises observing a positive result if a target virus or other target pathogen is present, or observing a negative result if a target virus or other target pathogen is not present.

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