Sample collection and analysis system

Abstract

A sample collection system includes a housing including an air inlet configured to receive an exhaled airflow; a porous sample collection medium disposed within the housing, the porous sample collection medium comprising a sample receiving region; an airflow passage extending from the air inlet through the sample receiving region of the porous sample collection medium; an assay device configured to receive the eluted sample from the porous sample collection medium; and a liquid flow passage extending from the sample receiving region of the porous sample collection medium to the assay device. The porous sample collection medium includes one or more reagents disposed on the porous sample collection medium along a liquid flow path.

Description

Cross-reference to related applications

[0001] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 63 / 543,206, filed on October 9, 2023, the disclosure of which is hereby incorporated by reference in its entirety. Background Technology

[0002] Diagnostic tests used to detect the presence of viruses or other pathogens in the airways, throat, or nasopharynx typically involve inserting a swab into the posterior part of the nasal passage, the middle turbinate region of the nasal passage, the anterior nasal cavity, the oral cavity, or the throat to obtain a sample. The swab is then placed in a container and analyzed or sent to a laboratory for processing. Other diagnostic tests involve collecting saliva samples and then placing them in a container.

[0003] In recent years, the demand for rapid viral testing has surged unprecedentedly due to the COVID-19 pandemic. To control the outbreak, large-scale scaling up of SARS-CoV-2 testing is needed in several different clinical and epidemiological contexts. Until recently, nasopharyngeal (NP) swabs were the preferred specimen type for the U.S. Centers for Disease Control and Prevention (CDC) because they were considered to provide the most reliable detection of patient infection. However, there are conflicting reports regarding which of the various specimen types carries the highest viral load.

[0004] However, sensitivity is a complex issue because upper respiratory tract (nasopharynx and oropharynx) detection is affected by a variety of factors, including the course of illness prior to testing and the limit of detection (LoD) of the RT-PCR analysis used. During the pandemic, the availability of NP swabs and the resources to establish NP collection sites with personnel to collect samples were key bottlenecks. To address these issues, healthcare systems have adopted several different strategies, including involving industrial manufacturers in the large-scale production of novel 3D-printed NP swabs and evaluating different sample types and alternative sample collection strategies, such as saliva.

[0005] The evaluation of nasal swabs and saliva is a rapidly growing area of ​​interest, particularly because these specimen types involve fewer invasive procedures than NP swabs. Therefore, patients can collect these samples themselves using a simple set of instructions, reducing the need for trained healthcare personnel for sample collection.

[0006] Many FDA Emergency Use Authorization (EUA) RT-PCR analyses have approved the use of nasal swabs as a specimen type, along with saliva, but it remains unclear how well these samples perform compared to NP swabs. To date, nasal swab studies have shown conflicting results, with some researchers reporting similar test performance to NP swabs, while others have found reduced sensitivity.

[0007] Currently available at-home virus tests (e.g., COVID-19 tests) include nasal swabs and test kits (e.g., ELLUME). ™ Testing, ABBOT ™ BinaxNOW ™ Tests and LUCIRA ™ (Single-molecule test kits). Tests using nasal swab samples or saliva are designed to combat contaminants that can interfere with various diagnostic tests. Therefore, these sample types require a purification step when using RT-PCR molecular tests.

[0008] There is a need for a simpler and cleaner sample collection and analysis system, one that facilitates sample elution and testing through user-friendly procedures. Furthermore, there is a need for a sample collection and analysis system that can also capture and elute samples with low SARS-CoV-2 viral loads that are still capable of transmitting the virus to others. A more accurate system is also needed to reduce human error and provide more reliable and reproducible test results. Summary of the Invention

[0009] There is a need for a cost-effective, easy-to-use, and reliable sample collection and analysis system that can be used by non-professionals to test for the presence of target viruses, target pathogens, or other target analytes in collected samples. The sample collection and analysis system may include a sample collection device for collecting samples from exhaled airflow and a testing and analysis device for determining the presence or absence of viruses, pathogens, or other analytes in the collected samples.

[0010] It is desirable to provide a system comprising a sample collection device and a testing device, which can be integrated as a single system or coupled together prior to testing. The system may advantageously include reagents used in the testing. The system may further include all components for collecting and testing samples. The system may be stand-alone and optionally sterile. Unlike swabs and other test collection devices that may be contaminated during use and / or during testing, a stand-alone, sterile system improves the accuracy and reliability of pathogen testing due to reduced contamination and background noise.

[0011] A further expectation is to provide a system that remains closed and independent after sample collection and optional testing to contain any potential viruses or pathogens, and that can be safely disposed of during routine waste collection. This system is independent to allow for the disposal of any potential viruses or pathogens, as well as any reagents used for testing.

[0012] A sample collection system includes: a housing including an air inlet configured to receive an exhaled airflow; a porous sample collection medium disposed within the housing, the porous sample collection medium including a sample receiving region; an airflow passage extending from the air inlet through the sample receiving region of the porous sample collection medium; a testing device configured to receive eluted samples from the porous sample collection medium; and a liquid flow passage extending from the sample receiving region of the porous sample collection medium to the testing device, the porous sample collection medium including one or more reagents disposed along the liquid flow passage on the porous sample collection medium. The one or more reagents may be disposed on an outer surface of the porous sample collection medium. The one or more reagents may extend through a thickness of the porous sample collection medium. The one or more reagents may be disposed downstream of the sample receiving region along the liquid flow passage. The one or more reagents may be disposed upstream of the sample receiving region along the liquid flow passage. The one or more reagents may be patterned.

[0013] A method for manufacturing a sample collection and analysis system includes: depositing one or more reagents on a porous sample collection medium to form a reagent zone; placing the porous sample collection medium within a housing along an airflow path extending from an air inlet to a sample receiving area on the porous sample collection medium; and coupling a testing device to the housing to form a liquid flow path through the sample receiving area, through the reagent zone, and to or into the testing device. The one or more reagents may be disposed on the outer surface of the porous sample collection medium. The one or more reagents may extend through a thickness of the porous sample collection medium. The one or more reagents may be disposed downstream of the sample receiving area along the liquid flow path. The one or more reagents may be disposed upstream of the sample receiving area along the liquid flow path. The one or more reagents may be patterned.

[0014] Deposition of one or more reagents may include applying a powder containing one or more reagents to a porous sample collection medium. Deposition of one or more reagents may include depositing an adhesive onto the porous sample collection medium and adhering a powder containing one or more reagents to the adhesive. Deposition of one or more reagents may include charging a region of the porous sample collection medium and adhering a powder containing one or more reagents to the charged region. Deposition of one or more reagents may include applying a powder containing one or more reagents to one side of the porous sample collection medium and evacuating a vacuum from the opposite side of the porous sample collection medium. Deposition of one or more reagents may include applying a powder containing one or more reagents to the porous sample collection medium by powder jetting. Deposition of one or more reagents may include transferring one or more reagents from a release surface to the porous sample collection medium. Deposition of one or more reagents may include adhering a powder containing one or more reagents to the porous sample collection medium using mechanical abrasion. Deposition of one or more reagents may include depositing a suspension containing one or more reagents onto the porous sample collection medium. Reagent regions may include patterns of one or more reagents and one or more regions where one or more reagents are absent. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the sample collection and analysis system according to the implementation plan.

[0016] Figures 2A-2D for Figure 1 A schematic diagram of the components of the sample collection and analysis system.

[0017] Figure 2E for Figure 1 A schematic diagram of a portion of a sample collection and analysis system, which includes a conjugate pad between a sample collection medium layer and a testing device.

[0018] Figure 3A This is a perspective view of the sample collection and analysis system according to the implementation plan.

[0019] Figure 3B for Figure 3A A cross-sectional perspective view of the sample collection and analysis system.

[0020] Figure 4A This is a perspective view of the sample collection and analysis system according to the implementation plan.

[0021] Figure 4B for Figure 4A A cross-sectional perspective view of the sample collection and analysis system.

[0022] Figure 5A A top view of the sample collection and analysis system according to the implementation plan.

[0023] Figure 5B for Figure 5A A cross-sectional side view of the sample collection and analysis system.

[0024] Figure 5C for Figure 5A A partial cross-sectional perspective view of the sample collection and analysis system.

[0025] Figure 6A This is a perspective view of the sample collection and analysis system according to the implementation plan.

[0026] Figure 6B for Figure 6A A top view of the sample collection and analysis system.

[0027] Figure 6C for Figure 6A A cross-sectional perspective view of the sample collection and analysis system.

[0028] Figure 7 for Figure 6A Bottom perspective view of the cover of the sample collection and analysis system.

[0029] Figure 8A for Figure 6A A perspective view of the base and internal components of the sample collection and analysis system.

[0030] Figure 8B for Figure 6A A partial top cross-sectional perspective view of the internal components of the sample collection and analysis system.

[0031] Figure 9 for Figure 6A A perspective view of the porous sample collection medium, conjugate pad, and testing apparatus within the sample collection and analysis system.

[0032] Figure 10 for Figure 6A A perspective view of the base of the housing of the sample collection and analysis system.

[0033] Figure 11A This is a side perspective view of the sample collection and analysis system according to the implementation plan.

[0034] Figure 11B for Figure 11A Top perspective view of the sample collection and analysis system.

[0035] Figure 11C for Figure 11A Detailed diagram of the base and internal components of the sample collection and analysis system.

[0036] Figure 11D for Figure 11A Detailed exploded view of the blister pack and base of the sample collection and analysis system.

[0037] Figure 12 This is a top perspective view of the sample collection and analysis system according to the implementation plan.

[0038] Figure 13 This is a top perspective view of the sample collection and analysis system according to the implementation plan.

[0039] Definitions

[0040] Unless otherwise specified, all scientific and technical terms used herein have their common meaning in the art. The definitions provided herein will facilitate understanding of certain terms used frequently herein and are not intended to limit the scope of this disclosure.

[0041] Unless otherwise stated, the terms "polymer" and "polymer material" include, but are not limited to, organic homopolymers, copolymers such as block, graft, random and syndiotactic copolymers, trimers, etc., and their blends and modifications. Furthermore, unless otherwise expressly limited, the term "polymer" shall include all possible geometries of the material. These geometries include, but are not limited to, isotactic, syndiotactic, and atactic symmetries.

[0042] The term “substantially” as used herein has the same meaning as “significantly” and can be understood as modifying the following term by at least about 90%, at least about 95%, or at least about 98%.

[0043] The term “substantially not” as used herein has the same meaning as “significantly not” and can be understood to have the opposite meaning of “substantially”, i.e., the following terms are modified to not exceed 25%, not exceed 10%, not exceed 5%, or not exceed 2%.

[0044] The term “ie” is used here as an abbreviation of the Latin word id est and means “that is”, while “eg,” is used as an abbreviation of the Latin phrase exempli gratia and means “for example.”

[0045] The term “about” is used here in conjunction with numerical values ​​to include normal variation in measured values ​​as expected by those skilled in the art, and is understood to have the same meaning as “approximately” and to cover typical error margins, such as ±5% of the specified value.

[0046] Terms such as “a,” “an,” “the,” and “the” are not intended to refer to a single entity, but rather to include general categories that can be used to illustrate specific examples.

[0047] The terms “a,” “an,” “the,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one of…” and “containing at least one of…” followed by a list refer to any item in the list or any combination of two or more items in the list.

[0048] As used herein, the term “or” is generally used in its usual sense, including “and / or”, unless the context clearly indicates otherwise. The term “and / or” means one or all of the listed elements, or any combination of two or more of the listed elements.

[0049] A range of values ​​expressed by endpoints includes all values ​​contained within that range (for example, 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 the range of values ​​is "at most" or "at least" a specific value, that value is included in the range.

[0050] As used herein, the terms “having,” “including,” “comprising,” etc., are used in their open-ended sense and generally refer to “including but not limited to.” It should be understood that “consistently made of,” “comprises from,” etc., are included within “including,” etc. As used herein, when “consistently made 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 and any other constituent elements that do not substantially affect the essential and novel characteristics of the composition, product, method, etc.

[0051] The terms "preferred" and "ideally" refer to embodiments that provide certain beneficial effects under certain circumstances. However, other embodiments may also be preferred under the same or other circumstances. Furthermore, the description of one or more preferred embodiments does not imply that other embodiments are unavailable, and is not intended to exclude other embodiments from the scope of this disclosure (including the claims).

[0052] For clarity, any directions and orientations mentioned herein, such as “top,” “bottom,” “left,” “right,” “upper,” “lower,” and others, are described with reference to the accompanying drawings. However, these directions and orientations are not intended to limit the actual device or system or its intended use. Devices or systems as described herein can be used in a variety of directions and orientations.

[0053] The terms "downstream" and "upstream" refer to the relative positions of components in the described system, which relate to the direction of liquid flow as the liquid flows along the liquid flow path of the sample collection system. For example, a component (e.g., a porous sample collection medium) may be located downstream of another component (e.g., an air inlet) in the direction of exhaled airflow through the device. Furthermore, a component (e.g., a reagent zone) may be located upstream or downstream of another component (e.g., a porous sample collection medium) in the direction of liquid flow. Detailed Implementation

[0054] There is a need for a simple, clean sample collection and analysis system, as well as easy sample testing. Furthermore, there is a need for a sample collection and analysis system that can also capture and elute samples with low analyte loads (e.g., pathogens, such as viruses). There is a need for a sample collection and analysis system capable of reliably detecting analytes (e.g., pathogens, such as viruses). There is a need for a sample collection and analysis system with enhanced sensitivity. There is a need for a more accurate system to reduce human error and provide more repeatable and reliable test results. There is a need for a sample collection and analysis system that does not require filtering to provide repeatable and reliable test results.

[0055] According to one embodiment, the sample collection and analysis system of this disclosure enables clean sample collection and easy sample testing. The sample collection and analysis system of this disclosure can capture and elute samples with low analyte loads (e.g., pathogens, such as viruses). According to one embodiment, the sample collection and analysis system of this disclosure can reliably detect analytes. According to one embodiment, the sample collection and analysis system of this disclosure can have enhanced sensitivity compared to conventional sample collection and analysis systems. According to one embodiment, the sample collection and analysis system of this disclosure provides repeatable and reliable test results and reduces human error.

[0056] This disclosure relates to a sample collection and analysis system. This disclosure relates to a bioaerosol collection device. This disclosure provides a system capable of collecting analytes from bioaerosol samples and testing for the presence of analytes in bioaerosol samples.

[0057] The sample collection and analysis system disclosed herein includes a sample collection device. The system includes a porous sample collection medium, one or more reagents and analytical devices disposed on the porous sample collection medium. The porous sample collection medium is configured to capture viruses, pathogens, or other analytes carried in exhaled airflow. The porous sample collection medium and analytical devices may be housed within a housing. The sample collection and analysis system may further include a liquid reservoir containing liquid. The liquid reservoir may contain a metered dose of liquid. The system is configured to collect analytes from bioaerosol samples and test for the presence of analytes in samples.

[0058] The sample collection and analysis system defines an airflow path extending from the air inlet through a porous sample collection medium. The porous sample collection medium at least partially obstructs the airflow path. The porous sample collection medium may completely obstruct the airflow path. The area of ​​the porous sample collection medium that receives airflow from the airflow path may be referred to as the sample receiving area. The airflow path may extend through the sample receiving area of ​​the porous sample collection medium. Exhaled airflow may pass through the thickness of the porous sample collection medium.

[0059] Porous sample collection media can be nonwoven materials configured to filter viruses, pathogens, or other analytes from exhaled airflow. Porous sample collection media can also be electrostatically charged nonwoven materials configured to filter viruses, pathogens, or other analytes from exhaled airflow. Porous sample collection media can be hydrophobic nonwoven materials configured to filter viruses, pathogens, or other analytes from exhaled airflow. In other cases, porous sample collection media can be hydrophilic nonwoven materials. Porous sample collection media can also be electrostatically charged hydrophobic nonwoven materials configured to filter viruses, pathogens, or other analytes from exhaled airflow. Porous sample collection media can be formed from polymeric materials. Suitable materials for porous sample collection media are discussed below. The term "hydrophobic" refers to a material having a water contact angle of 90 degrees or greater, 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. The water contact angle is measured using an automated contact angle tester with the ASTM D5727-1997 standard test method to measure the surface wettability and absorbency of sheet materials.

[0060] The sample collection and analysis system may further define a liquid flow path extending at least from the sample receiving area of ​​the porous sample collection medium to the assay apparatus. Liquid may be applied from a liquid reservoir to the porous sample collection medium. The liquid may be a metered dose of liquid contained in the liquid reservoir. The liquid may be applied onto the sample receiving area. The liquid may be applied upstream of the sample receiving area. The applied liquid may elute the sample captured in the sample receiving area of ​​the porous sample collection medium and flow to the assay apparatus. The liquid may further elute one or more reagents disposed on the porous sample collection medium, forming a mixture of liquid, sample, and one or more reagents (e.g., a liquid reaction mixture). The mixture may flow to the assay apparatus. One or more reagents may participate in the analysis of the sample.

[0061] Sample collection and analysis systems can be configured as a single integrated device. Such a single integrated device may include a sample collection device, a liquid reservoir, and a testing device for analyzing the sample. Furthermore, the testing device may include conjugate pads and membranes. Alternatively, one or more parts of the system may be provided as separate items. For example, the liquid reservoir may be provided as a separate item. Any part provided as a separate item may be coupled to a housing. For example, a liquid reservoir provided as a separate item may be coupled to a housing to deliver a metered dose of liquid. A testing device provided as a separate item may be coupled to a housing to receive eluted samples. Furthermore, conjugate pads and membranes may be provided as separate items that can be coupled to a housing to receive eluted samples.

[0062] A user can exhale into the sample collection and analysis system to collect bioaerosol samples of exhaled gas. The user can exhale into the nozzle or nosepiece of the sample collection and analysis system. The bioaerosol sample is captured in the sample receiving area of ​​a porous sample collection medium, forming a loaded porous sample collection medium. Liquid applied to the porous sample collection medium can travel to and through the surface and thickness of the loaded porous sample collection medium. The liquid can elute at least some of the sample and one or more reagents from the porous sample collection medium, thereby forming a liquid reaction mixture. The flow of the liquid reaction mixture from the porous sample collection medium to the assay device can create a delay time. The sample and one or more reagents can contact each other for at least the duration of the delay time. One or more reagents can react (e.g., bind to) a target analyte present in the porous sample collection medium. The reaction of one or more reagents with the target analyte can form an intermediate test compound. The intermediate test compound can be present in the liquid reaction mixture and flow (e.g., be wicked) onto or into the assay device. The intermediate test compound can further react with assay device reagents on the assay device. If the target analyte is present, a visible indicator may appear on the testing apparatus. The result can be observed visually or by using instruments such as a colorimeter (e.g., the presence or absence of the visible indicator).

[0063] The assay apparatus may be configured to analyze one or more analytes of interest. The assay apparatus may be integrated with a sample collection apparatus. The assay apparatus may form an integral element with the housing of the sample collection apparatus. The sample collection and analysis system may be configured to analyze different types of analytes. The analyte of interest may be a virus, bacteria, fungus, pathogen, biomarker, biomolecule, metabolite, or other analyte. In embodiments where the analyte of interest is a virus, it may be enveloped or non-enveloped. The virus may be a coronavirus, rhinovirus, norovirus, influenza virus, adenovirus, adeno-associated virus, varicella-zoster virus, herpesvirus, retrovirus, papillomavirus, enterovirus, arenavirus, or another type of virus. In some embodiments, the virus is present in the aerosol sample. In embodiments where the analyte of interest is a coronavirus, it may be COVID-19. In some embodiments, the analyte of interest is bacteria. The bacteria can be, for example, Mycobacterium tuberculosis, Streptococcus pneumoniae, Mycoplasma pneumoniae, Haemophilus influenzae, Chlamydia pneumoniae, Coxiella burnetiid, Moraxella catarrhalis, Histoplasma capsulatum, or Legionella pneumophila. In some embodiments, the analyte of interest is a fungus. This fungus can be, for example, Cryptococcus neoformans, Aspergillus fungi, Pneumocystis fungi, or endemic fungi. Biomarkers can be, for example, disease markers, such as cancer biomarkers. Other analytes may include alcohol or drugs, such as cannabis.

[0064] The sample collection and analysis system can be configured to analyze a single analyte. For example, it can be configured to analyze coronaviruses, rhinoviruses, noroviruses, influenza viruses, adenoviruses, adeno-associated viruses, varicella-zoster virus, herpesviruses, retroviruses, papillomaviruses, enteroviruses, arenaviruses, or another type of virus. The system can also be configured to analyze two or more analytes. For example, it can be configured to analyze two or more of the following: coronaviruses, rhinoviruses, noroviruses, influenza viruses, adenoviruses, adeno-associated viruses, varicella-zoster virus, herpesviruses, retroviruses, papillomaviruses, enteroviruses, arenaviruses, and another type of virus. In one embodiment, the system is configured to analyze both coronaviruses and influenza viruses.

[0065] The sample collection and analysis system disclosed herein includes an assay apparatus. This assay apparatus can be constructed using a conjugated pad and a membrane having a detection zone thereon. The assay apparatus may further include an absorbent overflow pad to facilitate liquid flow through the assay apparatus. The assay apparatus may be a modified lateral flow assay apparatus (LFA) as further described below. Examples of suitable LFAs include lateral flow test strips available from Merck Millipore, such as those described in the reference document entitled Rapid Lateral Flow Test Strips Considerations for Product Development (Merck Millipore Lit.No. TB500EN00MM), available at merckmillipore.com / INTERSHOP / web / WFS / Merck-RU-Site / ru_RU / - / USD / ShowDocument-Pronet?id=201306.15671, which is incorporated herein by reference. The testing apparatus used in the system disclosed herein may be similar to the testing apparatus described in the reference file, except that at least some of the reagents that are typically included on the conjugate pad are instead included on the porous sample collection medium.

[0066] The conjugation pad of the assay apparatus can be selected from any suitable material. Suitable materials may be nonwoven materials that allow the liquid reaction mixture to flow from the sample collection medium to the detection zone on the membrane. The conjugation pad may be formed from a nonwoven material. The conjugation pad may have low nonspecific binding to prevent analyte binding to the conjugation pad. The conjugation pad may have consistent flow characteristics to promote consistent flow to the membrane. The conjugation pad may have low extractability to limit the number of particles that may clog the membrane. Suitable materials for the conjugation pad include cellulose, glass, or plastics such as polyester (e.g., surface-modified polyester), polypropylene, or polyethylene.

[0067] The membrane for the analytical apparatus can be selected from any suitable material. Suitable materials can be based on the desired primary binding mechanism (e.g., electrostatic or hydrophobic). Suitable materials for membranes include, for example, polyethersulfone (PES), cellulose acetate, polyamides (nylon) coated to reduce nonspecific binding, cellulose nitrocellulose (collodion), polycarbonate, and coated olefins (polyethylene, polypropylene, or copolymers) coated to increase fluid wetting. The membrane can be selected based on porosity, capillary flow time, surface quality, or any other desired properties.

[0068] The absorbent overflow pad can be made from any suitable material. Suitable materials include any cellulose material. The absorbent overflow pad can be made of a material with the property of absorbing the total volume of sample entering the system to increase the sensitivity of the detection zone of the assay apparatus.

[0069] Sample collection and analysis systems may include one or more reagents disposed on or within a porous sample collection medium. Typical lateral flow assay devices include conjugate release pads (or simply conjugate pads) containing reagents. In the sample collection and analysis systems of this disclosure, at least some reagents are included in or on a porous sample collection medium that is also used to capture bioaerosol samples. Advantageously, in some embodiments, instead of including separate conjugate release pads, the reagents are included in a porous sample collection medium that is also used to capture bioaerosol samples. One or more reagents may participate in the analysis of the sample. One or more reagents may be eluted (e.g., dissolved) by a liquid released from a liquid reservoir and may be mixed with the eluted sample. One or more reagents may be selected such that they react (e.g., bind) with a target analyte present in the eluted sample.

[0070] Appropriate reagents can be selected based on the target analyte and the assay apparatus used to detect the target analyte. Reagents may include those typically used in lateral flow or vertical flow assay apparatuses. Such reagents may include various types of labeling reagents, such as those that can be used to generate visual indicators of test results. Examples of suitable reagents include antibodies conjugated with gold nanoparticles (e.g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), and combinations thereof.

[0071] One or more reagents disposed on or in a multi-well sample collection medium may include reagents selected for a single target analyte. For example, one or more reagents disposed on or in a multi-well sample collection medium may include reagents selected for analyzing coronavirus, rhinovirus, norovirus, influenza virus, adenovirus, adeno-associated virus, varicella-zoster virus, herpesvirus, retrovirus, papillomavirus, enterovirus, arenavirus, or another type of virus. Alternatively, one or more reagents disposed on or in a multi-well sample collection medium may include reagents selected for analyzing multiple target analytes. For example, one or more reagents disposed on or in a multi-well sample collection medium may include reagents selected for analyzing two or more of coronavirus, rhinovirus, norovirus, influenza virus, adenovirus, adeno-associated virus, varicella-zoster virus, herpesvirus, retrovirus, papillomavirus, enterovirus, arenavirus, or another type of virus. In one embodiment, one or more reagents disposed on or in a multi-well sample collection medium may include reagents selected for analyzing coronavirus and influenza virus.

[0072] A testing device may include a detection zone comprising components (e.g., antibodies or antigens) that react with the reaction products of analytes and reagents. If an analyte is present, the reaction in the detection zone can produce a visible indication, such as a test line or other visible shape. Systems that include reagents selected for two or more different analytes can provide a separate visible indication for each analyte.

[0073] Now for reference Figure 1An exemplary diagram of an exemplary sample collection and analysis system 1 is shown. According to an embodiment, system 1 includes both sample collection and testing capabilities. System 1 has a housing 100, a porous sample collection medium 130, and a testing device 300 disposed within the housing 100. The porous sample collection medium includes a sample receiving area 131. One or more reagents are disposed on the porous sample collection medium 130, thereby forming a reagent area 360. The reagent area 360 is shown surrounding the sample receiving area 131. However, as discussed further below, one or more reagents may be disposed upstream or downstream of the sample receiving area 131.

[0074] The reagent area 360 may also overlap with the sample receiving area 131. In an apparatus where the reagent area 360 overlaps with the sample receiving area 131, it is desirable that the reagent area 360 allow airflow through it. As discussed further below, the reagent area 360 may be patterned from reagents (and optionally adhesives) and may include one or more areas where one or more reagents are not present.

[0075] The sample collection and analysis system 1 further includes a liquid reservoir 200. A metered dose of liquid can be applied from the liquid reservoir 200 to a loaded sample collection medium 130. The flow of liquid 201 is indicated by a dashed arrow. Liquid 201 elutes the sample from the porous sample collection medium 130. Liquid 201 also elutes at least some of one or more reagents 360 in the liquid flow path. The liquid, the sample, and one or more reagents form a liquid reaction mixture 230. The liquid reaction mixture 230 flows (e.g., via capillary action) to a testing device 300, where it can further react with additional reagents in the detection zone 310.

[0076] Figures 2A-2D Alternative configurations of the porous sample collection medium 130, reagent zones 360A, 360B, 360C, 360D, and assay apparatus 300 are shown. In some embodiments, such as Figure 2A and Figure 2B As shown, reagent zones 360A and 360B are positioned downstream of sample receiving area 131 along liquid flow path 230. One or more reagents (e.g., reagent zones 360A and 360B) can be applied as dots, lines, or any other shape, including patterns of dots, lines, or other shapes. In one embodiment, reagent zone 360A is applied as a dot. In one embodiment, reagent zone 360B is applied as a line. The line may extend through liquid flow path 230. When reagent zones 360A and 360B are positioned downstream of sample receiving area 131, a metered dose of liquid may be applied to or upstream of sample receiving area 131, such that flowing liquid 201 elutes the sample and one or more reagents in reagent zones 360A and 360B.

[0077] In some implementation schemes, such as Figure 2C and Figure 2D As shown, one or more reagents 360C, 360D are disposed upstream of sample receiving area 131 along liquid flow path 230. One or more reagents (e.g., reagent areas 360C, 360D) can be applied as dots, lines, or any other shape (including patterns of dots, lines, or other shapes). In one embodiment, reagent area 360C is applied as a dot. In one embodiment, reagent area 360D is applied as a line. The line may extend through liquid flow path 230. When reagent areas 360C, 360D are disposed upstream of sample receiving area 131, a metered dose of liquid can be applied to or upstream of reagent areas 360C, 360D, such that flowing liquid 201 elutes the sample and one or more reagents in reagent areas 360C, 360D.

[0078] Figures 2A-2D The assay apparatus 300 shown may further include a conjugate pad disposed between the porous sample collection medium 130 and the membrane of the assay apparatus 300. For example, as Figure 2E As shown, reagent zone 360B is positioned downstream of sample receiving area 131 along liquid flow path 230, and conjugate pad 133 is partially disposed below porous sample collection medium 130, downstream of sample receiving area 131. When a metered dose of liquid is applied to or upstream of sample receiving area 131, flowing liquid 201 elutes the sample and one or more reagents in reagent zone 360B. The liquid, sample, and one or more reagents form liquid reaction mixture 230. Liquid reaction mixture 230 flows (e.g., by capillary action) onto conjugate pad 133 and elutes any additional reagents present in or on conjugate pad 133. Liquid reaction mixture 230 then continues to flow onto assay membrane 300, where it can further react with additional reagents in detection zone 310. Similar conjugate pads can be added. Figures 2A-2D In any of the components shown.

[0079] One or more reagents may be disposed on the outer surface of the porous sample collection medium. One or more reagents may extend through the thickness of the porous sample collection medium. One or more reagents may be disposed on the surface of fibers or particles of the porous sample collection medium.

[0080] There are no particular restrictions on the shape and construction of the housing, as long as it facilitates loading the porous sample collection medium with exhaled samples, applying liquid to the loaded porous sample collection medium, and allowing liquid to flow onto the testing apparatus. Apart from a housing that completely encloses the components of the system, the term "housing" is understood to mean a configuration in which the housing provides a platform or support for the components or only partially surrounds the components. Various types of sample collection and analysis systems, with or without modifications, applicable to the systems disclosed herein are described, for example, in PCT / US2021 / 034327 filed May 26, 2021; PCT / US2021 / 041485 filed July 13, 2021; PCT / IB2022 / 059989 filed October 18, 2021; PCT / US2022 / 012392 filed January 14, 2022; PCT / US2022 / 014388 filed January 28, 2022; PCT / IB2022 / 051250 filed February 11, 2022; and PCT / IB2022 / 034327 filed February 11, 2022. The following patents are incorporated herein by reference: PCT / IB2022 / 051251 (filed February 11, 2022); PCT / US2022 / 019399 (filed March 8, 2022); PCT / IB2022 / 054633 (filed May 18, 2022); PCT / IB2022 / 054683 (filed May 19, 2022); PCT / IB2022 / 054852 (filed May 19, 2022); PCT / IB2022 / 056708 (filed July 20, 2022); and PCT / IB2022 / 056714 (filed July 20, 2022). Other examples of suitable housing types include planar supports (e.g., laminated support platforms), sleeves, claddings, and tubing. The housing may partially or completely enclose some or all of the system's components. The housing may support some or all of the components from one, two, three, or more sides. Exemplary sample collection and analysis systems are discussed in further detail below.

[0081] According to the implementation scheme, the porous sample collection medium is suitable for 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 open space in a medium to the volume occupied by the medium material itself. A medium with high porosity has more open space, thus allowing for higher flow rates at lower pressure drops.

[0082] According to the implementation scheme, the porous sample collection medium is a nonwoven material carrying an electrostatic charge. The electrostatic charge enables 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, 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, configured to capture pathogens, viruses, or other analytes from the exhaled airflow.

[0083] Porous sample collection media can be formed from any suitable material capable of capturing viruses, pathogens, or other analytes from exhaled airflow and releasing the captured viruses, pathogens, or other analytes upon contact with an elution solution such as a saline solution. Porous sample collection media can be formed from polymeric materials. Porous sample collection media can be formed from polyolefins, cycloolefins, polymethylpentene, polyesters, or other electret materials. Examples of suitable polyolefins include polypropylene and combinations thereof. In one embodiment, the porous sample collection media is formed from polypropylene. In one embodiment, the porous sample collection media is formed from polyester. Suitable polyesters include polylactic acid and other polyesters that produce stable electrets. In one embodiment, the porous sample collection media comprises an electret made of polylactic acid. An exemplary porous sample collection media is commercially available from 3M Company (St. Paul MN, USA) under the trade name FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus Air Filter Merv 13.

[0084] Porous sample collection media can be inert. That is, the porous sample collection media may not react with the sample, one or more reagents, or liquids. The porous sample collection media does not change when collecting bioaerosol samples or when the sample is eluted. The porous sample collection media may be configured to release the collected aerosolized particles upon contact with a liquid (e.g., with a buffer solution). The porous sample collection media may be able to release the sample without mechanical agitation or chemical degradation.

[0085] Porous sample collection media can have a thickness of 200 µm or greater, or 250 µm or greater (orthogonal to the principal plane). Porous sample collection media can have a thickness of 750 µm or less, or 1000 µm or less. Porous sample collection media can have a thickness in the range of 200 µm to 1000 µm or 250 µm to 750 µm. Porous sample collection media can have a thickness of 1 cm.2 Or larger or 2cm 2 Or a larger (one-sided) principal plane surface area. Porous sample collection media can have 3 cm². 2 or smaller or 4cm 2 Or even smaller principal plane surface area. Porous sample collection media can have a surface area of ​​1 cm². 2 Up to 4cm 2 or 2cm 2 up to 3cm 2 The surface area of ​​the principal plane within the range.

[0086] The porous sample collection medium 120 may have a thickness (orthogonal to the principal plane) ranging from 200 μm to 1000 μm or 250 μm to 750 μm. The porous sample collection medium 120 may have a thickness of approximately 0.75 cm. 2 Approximately 6cm 2 Approximately 1cm 2 Approximately 4cm 2 Approximately 1cm 2 Approximately 3cm 2 Approximately 1.5cm 2 To approximately 2.5cm 2 or about 2cm 2 Approximately 3cm 2 The main plane surface area within the range.

[0087] One or more reagents may be applied to the porous sample collection medium by any suitable method. The reagents may be disposed on the outer surface of the porous sample collection medium. The reagents may penetrate the thickness of the porous sample collection medium.

[0088] Suitable methods for applying one or more reagents to a porous sample collection medium include methods for applying powder containing one or more reagents to the porous sample collection medium. The porous sample collection medium may first be treated in a manner that allows the powder to adhere to the porous sample collection medium. For example, an adhesive may first be applied to the porous sample collection medium, and the powder may be applied onto the adhesive. The adhesive may be deposited as dots, lines, or any other shape, or deposited in a pattern. The adhesive may be applied by inkjet printing, stripe coating, gravure printing, flexographic printing, spraying, screen printing, or a combination of two or more of these methods. The powder may be applied to the adhesive by powder spreading, powder jetting, needle transfer, screen printing, or any other suitable method, or a combination of two or more of these methods. Excess powder may be removed, for example, by vacuuming, blowing, brushing, or simply removing excess powder.

[0089] Alternatively, the porous sample collection medium can be processed to have a charge to which powder can adhere. The porous sample collection medium can be charged by triboelectric charging or by printing a charged material onto the porous sample collection medium. The charged areas can be applied as dots, lines, or any other shape or pattern. Powder containing one or more reagents is applied and adheres to the charged areas. Excess powder can be removed, for example, by vacuuming, blowing, brushing, or detaching the excess powder.

[0090] One or more reagents may be applied to a porous sample collection medium as a suspension containing one or more reagents. The suspension may be deposited by inkjet printing, needle transfer, stripe coating, gravure printing, flexographic printing, spraying, screen printing, stencil printing, or a combination of two or more thereof. In some embodiments, when one or more reagents are applied as a suspension, the porous sample collection medium may not require adhesive treatment or charging.

[0091] In some embodiments, one or more reagents are applied to the thickness of the porous sample collection medium. One or more reagents may be applied as powder to the surface of the porous sample collection medium and drawn into the thickness of the porous sample collection medium by evacuating from the opposite side of the porous sample collection medium. One or more reagents may be applied as powder by powder jetting. Powder jetting may have a speed at which at least some powder is delivered into the thickness of the porous sample collection medium.

[0092] In some embodiments, one or more reagents are applied to the porous sample collection medium by transferring one or more reagents from a release surface onto the porous sample collection medium. The porous sample collection medium may optionally be treated by applying an adhesive or charge prior to the application of the reagents.

[0093] In some embodiments, a powder containing one or more reagents is adhered to a porous sample collection medium by mechanical grinding, or one or more reagents are applied to the porous sample collection medium. The porous sample collection medium may optionally be treated by applying an adhesive or charge prior to the application of the reagents.

[0094] One or more reagents may be applied to a porous sample collection medium in any suitable shape or pattern, such as dots, lines, or any other shape. A pattern is understood to refer to multiple shapes, such as multiple dots, lines, or other shapes. One or more reagents may form reagent zones on the porous sample collection medium. In some embodiments, a reagent zone includes one or more areas in which one or more reagents are not present. For example, when one or more reagents are applied in a pattern to form a reagent zone, there may be areas within the pattern in which one or more reagents are not present.

[0095] Methods for manufacturing a sample collection and analysis system may include: depositing one or more reagents on a porous sample collection medium to form a reagent zone; placing the porous sample collection medium within a housing along an airflow path extending from an air inlet to a sample receiving area on the porous sample collection medium; and coupling a testing device to the housing to form a liquid flow path through the sample receiving area, through the reagent zone, and to the testing device or within the testing device.

[0096] The sample collection and analysis system may further include elements that facilitate sample collection, such as a nozzle or nasal tip, or another structure that facilitates breathing into the airflow pathway. For convenience, a nozzle is referred to herein, but it should be understood that the structure may also be a nasal tip or other suitable structure. The nozzle may be aligned with an inlet opening. The nozzle helps the user direct exhaled airflow onto the porous sample collection medium. The nozzle may be integral with the housing or removably connected to the housing. Alternatively, the sample may be loaded separately onto the porous sample collection medium (e.g., by using a separate sample collection device), and the loaded porous sample collection medium may be placed within the housing of the system.

[0097] The sample collection and analysis system may include a liquid reservoir. The liquid reservoir holds a metered dose of liquid. The liquid reservoir may be provided as a separate component or integrated into a housing. If provided as a separate component, the liquid reservoir may be used to manually (e.g., using a dropper) apply a metered dose of liquid to a porous sample collection medium, or the liquid reservoir may be coupled to a container on the housing.

[0098] A liquid reservoir may be disposed within a housing. The liquid reservoir may be formed from the housing itself, or it 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. A removable tab may removably seal the liquid reservoir. The removable tab may be sealed to an opening in the liquid reservoir via a peelable seal.

[0099] The liquid 201 dispensed onto 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 salt solution. The liquid may be a wetting liquid. 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 the reservoir and flow through or across the porous sample collection medium and onto the assay apparatus. For example, the surface tension of the liquid may be lower than that of water. When measured on the porous sample collection medium, the liquid may have a contact angle greater than 90 degrees. The liquid may be a salt solution containing a surfactant. The surfactant may be included in an amount that has the desired effect on surface tension, the amount varying with the surfactant. For example, the liquid (e.g., a buffer or wetting liquid) may contain 0.05% by weight or more, 0.075% by weight or more, 0.10% by weight or more, 0.15% by weight or more, or 0.2% by weight or more of a surfactant. The liquid may contain 2% or less, 1.5% or less, 1.25% or less, 1.0% or less, 0.8% or less, or 0.5% or less of a surfactant. The liquid may contain one or more surfactants at concentrations of 0.05% to 2% by weight, 0.075% to 1.5% by weight, or 0.1% to 1% by weight. In some embodiments, the liquid consists of water and one or more surfactants.

[0100] The liquid may contain any suitable surfactant that exhibits the desired wetting properties and does not interfere with the test. In some embodiments, the surfactant includes a nonionic surfactant. In some embodiments, the surfactant includes a polysorbate surfactant, an alcohol ethoxylate, or a combination thereof. Exemplary surfactants include TWEEN. ® 20 (polyethylene glycol dehydrated sorbitan monolaurate), purchased from Croda International PLC, Snaith, United Kingdom; SPAN ® 20 (sorbitol monolaurate), purchased from Croda International Group; BIO-SOFT ® GSB-9 (alcohol ethoxylate), purchased from Stepan Company, Northbrook, IL, USA; TERGITOL ™ NP-40 (nonylphenol ethoxylate), purchased from Dow Inc., Midland, MI, USA; TRITON ®X-100 (octylphenol ethoxylate), purchased from TALAS, Brooklyn, NY, USA, etc. In one embodiment, the liquid contains TWEEN. ® 20. In one embodiment, the liquid contains SPAN. ® 20. In one embodiment, the liquid contains BIO-SOFT. ® GSB-9. In one embodiment, the liquid comprises BIO-SOFT. ® GSB-9 and TWEEN ® A combination of 20. In one embodiment, the liquid contains 25% to 75% by weight of BIO-SOFT based on the total weight of the surfactant. ® GSB-9 and 25% to 75% TWEEN ® A combination of 20. In one embodiment, the liquid contains 50% by weight of BIO-SOFT based on the total weight of the surfactant. ® GSB-9 and 50% by weight of TWEEN ® A combination of 20. In one implementation, the liquid contains and SPAN ® A combination of 20.

[0101] The liquid can be supplied in a metered dose. That is, the liquid can be supplied in a predetermined dose. The metered dose can be contained in a liquid reservoir. Metered dose liquids can have volumes of 50 µL or more, 100 µL or more, 150 µL or more, 200 µL or more, 225 µL or more, 250 µL or more, 275 µL or more, or 300 µL or more. Metered dose liquids can have volumes of 750 µL or less, 500 µL or less, 400 µL or less, 375 µL or less, 350 µL or less, or 300 µL or less. Metered dose liquids can have volumes of 50 µL to 500 µL, 100 µL to 375 µL, 150 µL to 300 µL, 150 µL to 250 µL, or 175 µL to 225 µL. In some implementations, the volume of the metered liquid is proportional to the surface area of ​​the porous sample collection medium. The porous sample collection medium defines the main surface area, and the metered liquid defines the volume, with the volume divided by the surface area potentially reaching 10 μL / cm². 2 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 Within the range.

[0102] A liquid can be applied to a loaded porous sample collection medium. The liquid travels across the surface and thickness of the loaded porous sample collection medium, eluting any viruses, pathogens, or other analytes present on the loaded porous sample collection medium, as well as one or more reagents, thereby forming a mixture of liquid, sample, and one or more reagents (e.g., a liquid reaction mixture). The mixture can flow out of the porous sample collection medium and onto a testing device. The mixture can then be received by the detection area of ​​the testing device, and the presence of viruses, pathogens, or other analytes of interest can be tested.

[0103] The assay apparatus included in a sample collection and analysis system can be any suitable assay apparatus. The assay apparatus can be configured to determine the presence or absence of a target virus, pathogen, or analyte in a collected sample. In some embodiments, the assay apparatus can be a lateral flow assay apparatus (“LFA”), a vertical flow assay apparatus (“VFA”), or a colorimetric indicator. LFAs and VFAs are typically paper platforms used for detecting and quantifying analytes in complex mixtures, including biological samples such as saliva, urine, etc. LFAs and VFAs are generally easy to use and can be used by professionals in healthcare settings or laboratories, as well as by non-professionals at home. Typically, liquid samples are placed on the assay apparatus in the sample receiving area and drawn into the detection area via capillary flow along the wick. LFAs and VFAs are typically based on antigens or antibodies that are immobilized in the detection area and react selectively with the analyte of interest. Results are typically displayed within 5 to 30 minutes. LFAs and VFAs can be tailored to test for a wide variety of viruses and other pathogens, as well as many other types of analytes. According to embodiments, the laboratory apparatus used in the sample collection and analysis system of this disclosure is configured to detect target viruses, target pathogens, or other target analytes. According to embodiments, the laboratory apparatus used in the sample collection and analysis system of this disclosure is configured to detect target viruses, target pathogens, or other target analytes that may be present in the exhaled airflow of a subject. The laboratory apparatus used in the sample collection and analysis system of this disclosure may be configured to detect a single target analyte or multiple (e.g., two or more) target analytes.

[0104] Examples that may include commercially available LFAs in sample collection and analysis systems include AccessBioCARESTART. ™ COVID-19 antigen home test, Abbott BINAXNOW ™ COVID-19 Antigen Self-Test and QuidelQUICKVUE ® Home over-the-counter COVID-19 test.

[0105] Examples of colorimetric indicators include LFA colorimetric readers that utilize image sensors such as charge-coupled devices (CCDs) or complementary metal-oxide-semiconductor (CMOS). Such devices are useful, at least in part, due to their simple structure and small size. When used, the LFA generates test lines that are aggregates of labeled particles, antigens, and antibodies. The image sensor-based LFA reader acquires an image of the test lines and analyzes the pixel intensity of the test lines, which varies according to the concentration of the target analyte.

[0106] Now for reference Figures 3A-10 Exemplary sample collection and analysis systems 1001, 2001, 3001, and 4001 are discussed. In some implementations, such as Figure 3A and Figure 3B As shown, system 1001 includes a sample collection device 1100 and a liquid reservoir 1200. The sample collection device 1100 has a housing 1110 extending from a first end 1111 to a second end 1112. The housing 1110 may be formed of two portions 1101 and 1102, wherein the first portion 1101 is slidably received within the second portion 1102. The housing 1110 includes an opening 1230. The opening 1230 may be integrally formed on the second portion 1102. The opening 1230 may define an air inlet 1231 (or multiple air inlets 1231, as shown) of an airflow passage 1210. The air inlet 1231 is configured to receive exhaled airflow. A porous sample collection medium 1130 is fixed within the first portion 1101 of the housing. The first portion 1101 may include a support element 1122 (e.g., a ring) that, when the first portion 1101 is fully inserted into the second portion 1102, receives the porous sample collection medium 1130 and aligns it with the port 1230 along the airflow passage 1210. The porous sample collection medium 1130 may be secured within the housing 1100 along the airflow passage 1120. The porous sample collection medium 1130 at least partially obstructs the airflow passage 1120. A user exhales into the air inlet 1231. The exhaled airflow flows along the airflow passage 1120 and contacts the porous sample collection medium 1130.

[0107] A portion of the porous sample collection medium 1130 aligned with a plurality of air inlets 1231 forms a sample receiving region 1131. The porous sample collection medium 1130 further includes one or more reagents disposed in a reagent region 1360. The porous sample collection medium 1130 may be shaped to include an extension 1132 downstream of the sample receiving region 1131 to accommodate the reagent region 1360.

[0108] System 1001 further includes a laboratory apparatus 1300 for receiving samples to analyze analytes of interest. The laboratory apparatus 1300 is housed within a housing 1110. The laboratory apparatus 1300 may be disposed within a second portion 1102 of the housing 1110. The laboratory apparatus 1300 includes a detection zone 1310 positioned to receive a liquid reaction mixture, wherein the liquid reaction mixture may further react with additional reagents. The liquid reaction mixture may be wicked along a liquid flow path extending from the porous sample collection medium 1130 to the laboratory apparatus 1300 and the detection zone 1310. Test results appear at a result display area 1370. Results can be observed through an observation window 1270 of the housing 1110.

[0109] A user can collect a sample by exhaling into the port 1230 of the sample collection device 1100 to generate a loaded sample collection medium. A metered dose of liquid can then be applied from the liquid reservoir 1200 onto the loaded sample collection medium. The eluted liquid reaction mixture (containing the sample and one or more reagents) can flow to the analytical apparatus 1300 for analysis.

[0110] In some implementation schemes, such as Figure 4A and Figure 4B As shown, system 2001 includes a housing 2100 and a liquid reservoir 2200. The housing 2100 in these figures is transparent for illustrative purposes only. The housing 2100 extends from a first end 2101 (e.g., an inlet end) to a second end 2102 (e.g., an air outlet end), thereby defining an airflow passage 2120 from the first end 2101 to the second end 2102. The airflow passage 2120 may extend longitudinally along or parallel to the longitudinal axis A2000 of the housing 2100. The first end 2101 is configured to receive exhaled airflow through one or more inlets 2231. The second end 2102 may include an air outlet 2105. A porous sample collection medium 2130 is fixed within the housing 2100 along the airflow passage 2120. System 2001 further includes a laboratory apparatus 2300 for receiving samples for analysis of an analyte of interest. The laboratory apparatus 2300 is housed within the housing 2100. The testing apparatus 2300 is positioned to receive a sample from the porous sample collection medium 2130.

[0111] A user can collect a sample by exhaling into the first end 2101 of the housing 2100 to generate a loaded sample collection medium. A metered dose of liquid can then be applied from the liquid reservoir 2200 onto the loaded sample collection medium. The eluted liquid reaction mixture (containing the sample and one or more reagents) can then flow to the analytical apparatus 2300 for analysis.

[0112] A porous sample collection medium 2130 may be fixed within the housing 2100 along an airflow channel 2120. The porous sample collection medium 2130 at least partially obstructs the airflow channel 2120. A user exhales into an opening at a first end 2101 (e.g., the nozzle end). The exhaled airflow flows along the airflow channel 2120 and contacts the porous sample collection medium 2130. The exhaled airflow exits the sample collection device 2100 through one or more outlets 2105 at a second end 2102. The porous sample collection medium 2130 further includes one or more reagents disposed in a reagent area 2360.

[0113] The porous sample collection medium 2130 is illustrated as having a main plane that forms an angle with the direction of the incident exhaled airflow passing through the airflow channel 2120. This angle can be in the range of about 91 degrees to about 179 degrees, or about 100 degrees to about 160 degrees, or about 115 degrees to about 150 degrees, or about 125 degrees to about 145 degrees.

[0114] The housing 2100 may include a container 2220 configured to receive a liquid reservoir 2200. The liquid reservoir 2200 is configured to couple with the container 2220 and dispense a metered volume of fluid onto a porous sample collection medium 2130. The container 2220 defines an orifice 2222 through the housing 2100 and is adjacent to the porous sample collection medium 2130. The container 2220 is configured to direct fluid onto the porous sample collection medium 2130. The liquid reservoir 2200 may be attached to the container 2220 and is movable between a first fluid-loaded position and a second fluid-depleted position, wherein the second fluid-depleted position may be closer to the housing than the first fluid-loaded position. In the first fluid-loaded position, the liquid reservoir 2200 contains a metered volume of liquid, and in the second fluid-depleted position, the metered liquid reservoir 2200 delivers a metered volume of liquid onto the porous sample collection medium 2130. Figure 4B The liquid reservoir 2200 is shown in the second fluid depletion position.

[0115] Liquid reservoir 2200 may include a reservoir with a seal that breaks when liquid reservoir 2200 is applied to a corresponding container 2220 on housing 2110. Container 2220 may include a protrusion that breaks the seal on liquid reservoir 2200 and an opening that allows reagent composition to enter housing 2100. Container 2220 and porous sample collection medium 2130 may be positioned such that liquid released from liquid reservoir 2200 flows onto porous sample collection medium 2130. An exemplary liquid reservoir 2200 is commercially available from 3M Corporation (St. Paul, Minnesota, USA) under the trademark CUROS. In such an embodiment, container 2112 (e.g., the protrusion) may include a threaded wall that displaces a plunger within liquid reservoir 2200 and releases liquid.

[0116] The assay apparatus 2300 includes a detection zone 2310 positioned to receive a liquid reaction mixture, wherein the liquid reaction mixture may be further reacted with additional reagents. The liquid reaction mixture may be wicked along a liquid flow path extending from the porous sample collection medium 2130 to the assay apparatus 2300 and the detection zone 2310. Test results can be observed through an observation window 2270 in the housing 2100.

[0117] In some implementation schemes, such as Figures 5A-5C As shown, a liquid reservoir 3200 is integrated into a housing 3100 of system 3001. According to an embodiment, the liquid reservoir 3200 has a volume V3200 for containing a metered dose of liquid for eluting a sample from a porous sample collection medium 3130 and one or more reagents 3360. The liquid reservoir 3200 is in fluid communication with (e.g., adjacent to or adjacent to) the porous sample collection medium 3130 such that when liquid is released from the liquid reservoir 3200, it can flow onto the porous sample collection medium 3130. The liquid reservoir 3200 defines an opening 3220, which is removably sealed by a removable tab 3250. The removable tab 3250 is positioned between the opening 3220 and the porous sample collection medium 3130. In the illustrated embodiment, the liquid reservoir 3200 overlaps with the porous sample collection medium 3130. Alternatively, the liquid reservoir 3200 may be in fluid communication with (e.g., adjacent to or close to) the porous sample collection medium 3130, such that liquid from the liquid reservoir 3200 flows onto the porous sample collection medium 3130.

[0118] exist Figures 5A-5C In the illustrated embodiment, the liquid reservoir 3200 is formed as part of the port 3120. The port 3120 may be formed by a hollow ring 3122 surrounding the air inlet 3121. The liquid reservoir 3200 may be formed in the expansion portion of the hollow ring 3121.

[0119] The liquid reservoir 3200 may include a capsule 3210 containing liquid disposed within the liquid reservoir 3200. The volume V3200 of the liquid reservoir 3200 may be defined by the capsule 3210. The capsule 3210 may be removably sealed by a tab 3250. The sealed capsule 3210 may be placed within the liquid reservoir 3200.

[0120] The removable tab 3250 includes a first portion 3251 and a second portion 3252. The first portion 3251 may be a sealing portion abutting (e.g., sealing to) an opening 3220. The second portion 3252 may extend from the housing 3100 and may form a pull tab. A user may pull the second portion 3252 to release a metered dose of liquid.

[0121] System 3001 further includes a testing device 3300 disposed within housing 3100 and configured to receive a liquid reaction mixture (including an eluted sample and one or more reagents) from a porous sample collection medium 3130. The testing device 3300 includes a conjugate pad 3330 and a membrane 3301, the membrane including a detection zone 3310 positioned to receive the liquid reaction mixture, wherein the liquid reaction mixture may further react with additional reagents. According to one embodiment, the testing device 3301 is in direct contact with the porous sample collection medium 3130. For example, a portion of the membrane 3301 may overlap with the porous sample collection medium 3130. In another embodiment, the conjugate pad 3330 is disposed between the porous sample collection medium 3130 and the membrane 3301, and is in direct contact with the porous sample collection medium 3130. For example, a portion of the conjugate pad 3330 may overlap with the porous sample collection medium 3130. A liquid reaction mixture can be wicked from the porous sample collection medium 3130 onto the conjugate pad 3330, and further wicked onto the detection zone 3310 on the membrane 3301. The assay device 3300 can be a flow assay device, such as a lateral flow assay device or a vertical flow assay device. The assay device 3300 can be configured to detect viruses or other pathogens or analytes. Test results can be displayed in the detection zone 3310 to indicate the presence or absence of viruses or other pathogens or analytes. The housing 3100 may include a corresponding result observation window 3170 through which the detection zone 3310 can be observed.

[0122] The liquid storage tank 4200 is integrated into Figures 6A-6C Another embodiment of the system in the housing 4100 of the illustrated system 4001. According to this embodiment, the liquid reservoir 4200 has a volume V4200 for containing a metered dose of liquid for eluting a sample from a porous sample collection medium 4130 and one or more reagents 4360. The liquid reservoir 4200 is in fluid communication with (e.g., adjacent to or immediately adjacent to) the porous sample collection medium 4130 such that when liquid is released from the liquid reservoir 4200, it can flow onto the porous sample collection medium 4130. The liquid reservoir 4200 defines an opening 4220, which is removably sealed by a removable tab 4250. The removable tab 4250 is positioned between the opening 4220 and the porous sample collection medium 4130. In the illustrated embodiment, the liquid reservoir 4200 overlaps with the porous sample collection medium 4130. Alternatively, the liquid reservoir 4200 may be in fluid communication with (e.g., adjacent to or adjacent to) the porous sample collection medium 4130, such that liquid from the liquid reservoir 4200 flows onto the porous sample collection medium 4130.

[0123] exist Figures 6A-6CIn the illustrated embodiment, system 4001 includes an exhalation inlet 4120 shaped to facilitate sampling via a tube tip (oral exhalation) and nose (nasal exhalation). The exhalation inlet 4120 may be formed by a tapered protrusion 4121 surrounding an air inlet 4122. A liquid reservoir 4200 may be accommodated within the tapered protrusion 4121 of the exhalation inlet 4120.

[0124] Liquid reservoir 4200 may include a capsule 4210 for containing liquid disposed within a conical protrusion 4121. The volume V4200 of liquid reservoir 4200 may be defined by capsule 4210. Capsule 4210 may be removably sealed by tab 4250. The sealed capsule 4210 may be placed within conical protrusion 4121.

[0125] The removable tab 4250 may include a first portion 4251 and a second portion 3452. The first portion 4251 may be a sealing portion abutting (e.g., sealing to) an opening 4220. The second portion 4252 may extend from the housing 4100 and may form a pull tab. A user may pull the second portion 4252 to release a metered dose of liquid.

[0126] System 4001 further includes a testing device 4300 disposed within housing 4100. The testing device 4300 may be configured to receive a liquid reaction mixture (including an eluted sample and one or more reagents) from a conjugate pad 4330 of a porous sample collection medium 4130. The porous sample collection medium 4130 and the testing device 4300 assembly are located within... Figure 9 The assay device is shown in the figure. It includes a conjugated pad 4330 and a membrane 4301, the membrane including a detection zone 4310 positioned to receive a liquid reaction mixture. The liquid reaction mixture can react with additional reagents on the conjugated pad 4330. The liquid reaction mixture can further react with additional reagents in the detection zone 4310. According to an embodiment, the conjugated pad 4330 can overlap with a porous sample collection medium 4130. The liquid reaction mixture can be wicked from the porous sample collection medium 4130 onto the conjugated pad and further wicked onto the membrane 4301. The assay device can be a flow assay device, such as a lateral flow assay device or a vertical flow assay device. In the illustrated embodiment, the assay device 4300 is a lateral flow assay device. The detection zone 4310 of the assay device can be configured to detect viruses or other pathogens or analytes. Test results can be displayed in the detection zone 4310 to indicate the presence or absence of viruses or other pathogens or analytes. For example, a control line 4312 and a positive line 4311. The housing 4100 may include a corresponding result observation window 4170 through which the detection area 4310 can be observed.

[0127] In some implementation schemes, such as Figures 7-8BAs shown, the housing 4100 includes a pressure tab 4400 to apply pressure to the porous sample collection medium 4130. The pressure tab 4400 is configured to apply pressure to improve contact, thereby improving liquid flow between the porous sample collection medium 4130 and the conjugate pad 4330, and between the conjugate pad 4330 and the membrane 4301. The contact between the porous sample collection medium 4130, the conjugate pad 4330, and the membrane 4301 ensures that the liquid reaction mixture can be drawn from the porous sample collection medium 4130 wick onto the detection area 4310 on the membrane 4301. The pressure tab 4400 may be positioned upstream or downstream of the reagent 4360, or may overlap with the reagent 4360. In some embodiments, the pressure tab 4400 is positioned downstream of the reagent 4360. The distance from the capsule 4210 to the pressure tab 4400 can be measured by distance D4400. The distance D4400 can be any suitable distance to facilitate sample elution, reagent dissolution 4360, and flow of sample and reagent to the detection zone 4310. Too short a distance may not allow sufficient time for sample elution and / or reagent dissolution, while too long a distance may not effectively facilitate flow to the conjugate pad 4330 and membrane 4301. A suitable distance D4400 may depend on the specific configuration and placement of the porous sample collection medium 4130, the conjugate pad 4330, and the membrane 4301. In some embodiments, the distance D4400 is 2 mm or greater, 4 mm or greater, or 6 mm or greater. In some embodiments, the distance D4400 is 10 mm or less, 8 mm or less, or 6 mm or less. In some embodiments, the distance D4400 is 2 mm to 10 mm, 4 mm to 8 mm, or about 6 mm.

[0128] In some implementation schemes, such as Figure 10 As shown, the sample collection and analysis system has a porous sample collection medium 4130 and a conjugate pad 4330 at a predetermined height H4300. Height H4300 defines the distance from the bottom of the liquid reservoir 4210 to the membrane 4301. In some embodiments, height H4300 may be in the range of approximately 2 mm to 3 mm.

[0129] In some embodiments, the metered dose of liquid may be stored in a blister pack or bag, rather than in a reservoir with a pull tab. The blister pack may be housed within a housing such that the blister pack or bag can rupture to release the metered dose of liquid onto porous sample collection material. Examples of such embodiments are shown in... Figures 11A-11D As shown in the diagram. System 5001 may otherwise be similar to Figures 6A-10The system 4001 shown differs in that instead of housing the liquid reservoir 4210 inside the conical protrusion 4121, a liquid reservoir 5210 formed as a blister pack is housed between the conical protrusion 5121 and the detection zone 5310. The liquid reservoir (blister pack) 5210 can be aligned on top of the porous sample collection medium 5130. To guide exhaled airflow from an inlet in the conical protrusion 5121 to the porous sample collection medium 5130, the housing 5100 may include a tilting slider 5170. The housing 5100 may include an opening 5102 through which the liquid reservoir (blister pack) 5210 protrudes, forming a "button" that a user can push to break the blister pack and release a metered dose of liquid. One or more puncture elements may be positioned below the liquid reservoir (blister pack) 5210 to help puncture the bottom of the liquid reservoir (blister pack) 5210 (see [link to relevant documentation]). Figure 11D A liquid reservoir (blister pack) 5210 may be housed within a nest 5270. The nest 5270 may include a plurality of puncture elements 5271 extending upward toward the bottom of the liquid reservoir (blister pack) 5210. The bottom of the liquid reservoir (blister pack) 5210 may be made of foil or other ruptureable material. The nest 5270 may further include an opening 5272 through which a metered dose of liquid is transferred from the liquid reservoir (blister pack) 5210 to a porous sample collection medium 5130. The opening 5272 may be positioned at the center of the nest 5270, below the liquid reservoir (blister pack) 5210. The nest 5270 may further include a vent 5273 to allow air to escape once the metered dose of liquid has been released. The vent 5273 may extend from a central bowl-shaped member 5274 of the nest 5270 through its sides to the exterior of the nest 5270.

[0130] In another implementation, such as Figure 12 As shown, a hinged flap can be used to push the blister pack or bag to cause the blister pack to break. System 6001 (which may otherwise be similar to) Figures 11A-11C The system 5001 shown includes a hinged flap 6700 aligned with a liquid reservoir 6210 (e.g., a blister pack or bag). The hinged flap 6700 is foldable onto a housing 6100 to push the liquid reservoir 6210 and cause it to break. The hinged flap 6700 may include a protrusion 6701 aligned with the liquid reservoir 6210.

[0131] exist Figure 13 In another embodiment shown, a movable hinge can be used to push the liquid reservoir 7210 (e.g., a blister pack or bag) to cause the blister pack to rupture. System 7001 (which may otherwise be similar to...) Figure 12The system 6001 shown includes a movable hinge assembly 7700 aligned with a liquid reservoir 7210 (e.g., a blister pack or bag). The center of the movable hinge assembly 7700 can be pushed downward against the housing 7100, thereby breaking the active hinge tab 7800. The actuated movable hinge assembly then pushes the liquid reservoir 7210 and causes it to break.

[0132] The sample collection and analysis system discussed herein may include areas for writing or otherwise indicating identifying information such as names, initials, account numbers, etc.

[0133] Sample collection and analysis systems may also include machine-readable optical tags. Such tags may include, for example, barcodes and QR (Quick Response) codes. Machine-readable optical tags can be configured to display the results of the testing device. Machine-readable optical tags can be used to read and record results. Electronic readers capable of reading machine-readable optical tags can be used to read and record results. Electronic readers may be, for example, smartphones, tablets, laptops, or barcode or QR code readers. Electronic readers can also be used to transmit results to, for example, healthcare providers or databases.

[0134] The housing may be formed of a rigid material (such as plastic) or a paper material (such as cardboard or paperboard). In some embodiments, the housing is made of plastic. The housing may be made of a material that does not absorb any liquid or eluent. For example, the housing may be made of a hydrophobic material. In some embodiments, at least a portion of the housing is transparent. For example, the housing may include a transparent material in the area where the results of the assay device are displayed. The housing may include an observation window (transparent material or opening) in the area where the results are displayed. In some cases, the entire housing may be made of a transparent material. The housing may also include a cap or seal configured to prevent contamination before or after use of the system. The cap or seal may be removable (e.g., removable before use). The cap or seal may be closable and / or reclosable (e.g., closable after use).

[0135] The housing may include a pre-filter or screen disposed in an airflow path 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. Exhaled airflow passes through the thickness of the pre-filter or screen. The pre-filter or screen at least partially obstructs the airflow path. In some cases, the pre-filter or screen may have a main plane 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 nonwoven layer 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 nonwoven layer without electrostatic charge. In some embodiments, the pre-filter or screen does not capture significant amounts of viral material, pathogen material, or other analyte material, but rather allows them to pass through the pre-filter or screen. In some embodiments, the pre-filter or screen is made of or includes at least one of the following: plastic mesh, woven mesh, needle-punched fiber mesh, knitted mesh, extruded mesh, and / or carded or spunbond covering material.

[0136] A user can exhale into the sample collection device and load the porous sample collection medium with the exhaled airflow to form a loaded porous sample collection medium. For example, the user can exhale through an air inlet or through a nozzle or nasal spout. The housing can be configured such that the exhaled airflow passes through the porous sample collection medium when exhaled through a single opening, air inlet, nozzle, or nasal spout. The porous sample collection medium is configured to capture viruses, other pathogens, or other analytes from the exhaled airflow. The user can then release a metered dose of liquid from a liquid reservoir to apply the liquid to the loaded porous sample collection medium and elute the captured sample, along with one or more reagents disposed on the porous sample collection medium, to the assay device. The user can use the assay device to test for the presence of viruses, pathogens, or other analytes in the eluent. This test can be performed with the loaded porous sample collection medium in place within the sample collection and analysis system.

[0137] A method of using a sample collection and analysis system may include: exhaling into an air inlet (e.g., into a tube opening) 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, thus eluting the sample and one or more reagents from the loaded porous sample collection medium, and allowing the eluted sample to flow onto a testing device; and observing the test results in a results display of the testing device. The method may also include reading the results display of the testing device using an electronic reader.

[0138] According to the implementation plan, the sample collection and analysis system is formed as a single, independent unit. Providing an independent unit allows for convenient transport and delivery of the sample collection and analysis system and allows for post-use disposal. The independent unit can be compact in size and easily carried in a pocket or purse. The independent unit can be safely disposed of in ordinary waste disposal after use.

[0139] The testing apparatus may be a separate element from the sample collection apparatus. The testing apparatus may be configured to be attached to the sample collection apparatus. The sample collection apparatus may include a container for receiving at least a portion of the testing apparatus. The sample collection apparatus may include a container for receiving the entire testing apparatus. The testing apparatus may be a replacement element for the sample collection apparatus.

[0140] Similarly, the liquid reservoir may be a separate element from the sample collection device and may be configured to be received by a housing. The housing may include a container for receiving the liquid reservoir. The liquid capsule may be a replacement element for the sample collection device. An exemplary metering fluid dosing element is available from 3M Corporation (St. Paul, Minnesota, USA) under the trademark CUROS.

[0141] The sample collection and analysis system may be provided as a kit. The kit may include the sample collection and analysis system discussed above, along with instructions for collecting samples and testing samples using the assay apparatus. The instructions may include the following: exhaling along the airflow pathway to capture the sample in the porous sample collection medium; moving or removing a removable tab to release a dose of liquid onto the porous sample collection medium; and observing the test results in the assay apparatus's results display. The instructions may also include instructions for reading the assay apparatus's results display using an electronic reader.

[0142] Example 1

[0143] Tests were conducted to evaluate the suitability of different surfactants for use in the device to elute samples, dissolve reagents, and transfer samples and reagents to the detection area of ​​the assay apparatus. For testing the preparation of liquids, only the base of the housing containing the assay apparatus and sample collection medium was used, such as... Figure 8A As shown, there is no liquid reservoir 4200. The sample collection medium has a basis weight of 68-94 g / m³. 2 PLA media within the range.

[0144] The surfactants tested included SPAN. ® 20. BIO-SOFT ® GSB-9, TWEEN ® 20 and BIO-SOFT ® GSB-9 and TWEEN ®A combination of 20. The surfactant is mixed with water at a concentration of 0.5% by weight (all surfactants) to 1.5% by weight (SPAN). ® 20 and BIO-SOFT ® GSB-9) or up to 2% by weight (TWEEN) ® 20) Concentration mixing within the range.

[0145] The fluid was applied using a pipette at a measured dose ranging from 150 μL to 250 μL. Each test was repeated at least 10 times and at most 42 times.

[0146] The ability of the sample to flow all the way to the end of the assay strip (“complete flow”) and produce a strong control line was observed. Other observations were also made, including leakage under the device, indicating slow absorption, and the onset of flow rate and capillary action.

[0147] The tested liquids and a summary of the results are shown in Table 1 below. Fully flowable liquids are abbreviated as "CF" in the table.

[0148]

[0149] Observed TWEEN ® 20 generates the strongest control line, while BIO-SOFT ® GSB-9 and SPAN ® Both 20 exhibited weak control lines. BIO-SOFT was observed. ® GSB-9 has the best wetting properties, followed by TWEEN. ® 20, then SPAN ® 20.1% by weight of TWEEN ® 20 and 1% by weight and 1.5% by weight of SPAN ® 20 led to leakage, indicating slow absorption into the PLA. BIO-SOFT was observed. ® GSB-9 and TWEEN ® 20 performed better in detecting movement from the conjugate pad, exhibiting fewer streaks or ghosting. Further observations were made using BIO-SOFT. ® GSB-9 and TWEEN ® A 20 / 50 combination yields the best overall performance.

[0150] Example 2

[0151] Tested Figures 6A-10The sample collection and analysis device shown was used to test its suitability for COVID-19. Four COVID-19 positive test subjects were instructed to exhale through their noses into the airflow pathway of the device to capture samples in the porous sample collection medium. The test subjects exhaled five times into the device from each nostril. The test subjects were further instructed to remove the tongue pull to release liquid onto the sample collection medium. After approximately five minutes, a positive result was observed in the detection area of ​​the device for each of the four test subjects. The conclusion is that the device is suitable for collecting and analyzing nasal exhaled samples for COVID-19 detection.

[0152] Embodiments

[0153] The following is a list of exemplary implementations based on this disclosure.

[0154] Implementation scheme 1 is a sample collection system, which includes:

[0155] The housing includes an air inlet configured to receive exhaled airflow;

[0156] A porous sample collection medium disposed within the housing, the porous sample collection medium including a sample receiving area;

[0157] An airflow passage extends from the air inlet through the sample receiving area of ​​the porous sample collection medium;

[0158] A testing apparatus configured to receive eluted samples from the porous sample collection medium; and

[0159] A liquid flow path extends from the sample receiving area of ​​the porous sample collection medium to the testing device.

[0160] The porous sample collection medium includes one or more reagents disposed along the liquid flow path on the porous sample collection medium.

[0161] Implementation scheme 2 is a sample collection and analysis system according to implementation scheme 1, wherein the one or more reagents are disposed on the outer surface of the porous sample collection medium.

[0162] Implementation scheme 3 is a sample collection and analysis system according to implementation scheme 1 or 2, wherein the one or more reagents penetrate the thickness setting of the porous sample collection medium.

[0163] Implementation scheme 4 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the testing device, and wherein the one or more reagents are disposed downstream of the sample receiving area along the liquid flow path.

[0164] Implementation scheme 5 is a sample collection and analysis system according to any one of the preceding implementation schemes, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the testing device, and wherein the one or more reagents are disposed upstream of the sample receiving area along the liquid flow path.

[0165] Implementation scheme 6 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the one or more reagents are arranged in a pattern.

[0166] Implementation scheme 7 is a sample collection and analysis system according to any one of the preceding implementation schemes, wherein the reagent area includes one or more areas in which the one or more reagents are not present.

[0167] Embodiment 8 is a sample collection and analysis system according to any one of the preceding embodiments, wherein the housing includes a nozzle or nose-shaped element, and wherein the air inlet extends through the nozzle or nose-shaped element.

[0168] Implementation scheme 9 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the system includes a liquid reservoir.

[0169] Implementation scheme 10 is a sample collection and analysis system according to implementation scheme 9, wherein the liquid reservoir is disposed within the housing.

[0170] Implementation scheme 11 is a sample collection and analysis system according to implementation scheme 9, wherein the liquid reservoir is coupled to the housing.

[0171] Implementation scheme 12 is a sample collection and analysis system according to any one of implementation schemes 9 to 11, wherein the liquid reservoir contains a metered dose of liquid.

[0172] Implementation scheme 13 is a sample collection and analysis system according to implementation scheme 12, wherein the measured dose of liquid has a volume in the range of 50 μL to 1500 μL or 100 μL to 1000 μL.

[0173] Implementation scheme 14 is a sample collection and analysis system according to implementation scheme 12, wherein the porous sample collection medium defines a surface area and the metered liquid has a volume, and wherein the volume divided by the surface area is in the range of 10 μL / cm². 2 Up to 400 μL / cm 2 or 10 μL / cm 2 Up to 250 μL / cm 2 .

[0174] Embodiment 15 is a sample collection and analysis system according to any one of Embodiments 12 to 14, wherein the metered dose of liquid comprises an aqueous solution, optionally a buffer solution, and optionally contains a surfactant.

[0175] Implementation scheme 16 is a sample collection and analysis system according to any one of the preceding implementation schemes, wherein the testing device includes a lateral flow testing device (“LFA”) or a vertical flow testing device (“VFA”).

[0176] Implementation scheme 17 is a sample collection and analysis system according to any one of the preceding implementation schemes, wherein the testing device is configured to detect the presence of viruses, bacteria, fungi, pathogens, biomarkers, biomolecules, metabolites or other analytes.

[0177] Implementation scheme 18 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the housing includes a test result display window.

[0178] Implementation scheme 19 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the one or more reagents include one or more labeling reagents, optionally wherein the one or more reagents include antibodies conjugated with gold nanoparticles (e.g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots) or combinations of two or more of them.

[0179] Implementation scheme 20 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the porous sample collection medium includes a nonwoven filter layer with electrostatic charge.

[0180] Implementation scheme 21 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the porous sample collection medium includes a hydrophobic nonwoven filter layer.

[0181] Implementation scheme 22 is a sample collection and analysis system according to any one of the foregoing implementation schemes, wherein the one or more reagents are adhered to the porous sample collection medium by an adhesive.

[0182] Implementation scheme 23 is a method for manufacturing a sample collection and analysis system, the method comprising:

[0183] One or more reagents are deposited on a porous sample collection medium to form a reagent zone;

[0184] The porous sample collection medium is placed inside the housing along an airflow path extending from the air inlet to the sample receiving area on the porous sample collection medium; and

[0185] The testing device is coupled to the housing to form a liquid flow path through the sample receiving area, through the reagent area, and to the testing device or to the testing device.

[0186] Implementation scheme 24 is the method according to implementation scheme 23, wherein the one or more reagents are disposed on the outer surface of the porous sample collection medium.

[0187] Implementation scheme 25 is the method according to implementation scheme 23 or 24, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the assay device, and wherein the one or more reagents are disposed downstream of the sample receiving area along the liquid flow path.

[0188] Implementation scheme 26 is a method according to any one of implementation schemes 23 to 25, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the assay device, and wherein the one or more reagents are disposed upstream of the sample receiving area along the liquid flow path.

[0189] Embodiment 27 is a method according to any one of embodiments 23 to 26, wherein the deposition of the one or more reagents comprises applying a powder containing the one or more reagents onto the porous sample collection medium.

[0190] Embodiment 28 is a method according to any one of embodiments 23 to 27, wherein the deposition of the one or more reagents includes depositing an adhesive onto the porous sample collection medium and adhering a powder containing the one or more reagents to the adhesive.

[0191] Implementation scheme 29 is the method according to implementation scheme 28, wherein the adhesive is deposited in a pattern.

[0192] Implementation scheme 30 is the method according to implementation scheme 28 or 29, wherein the adhesive is applied by inkjet printing, strip coating, gravure printing, flexographic printing, spraying, screen printing or a combination of two or more of them.

[0193] Implementation scheme 31 is a method according to any one of implementation schemes 23 to 30, wherein the deposition of the one or more reagents includes charging a region of the porous sample collection medium and adhering powder containing the one or more reagents to the charged region.

[0194] Implementation scheme 32 is the method according to implementation scheme 31, wherein the charging includes triboelectric charging.

[0195] Implementation scheme 33 is the method according to implementation scheme 31, wherein the charging includes printing a charged material onto the porous sample collection medium.

[0196] Implementation scheme 34 is a method according to any one of implementation schemes 23 to 33, wherein the deposition of the one or more reagents includes applying a powder containing the one or more reagents to one side of the porous sample collection medium and evacuating the opposite side of the porous sample collection medium.

[0197] Embodiment 35 is a method according to any one of embodiments 23 to 34, wherein the deposition of the one or more reagents comprises applying a powder containing the one or more reagents onto the porous sample collection medium by powder spraying.

[0198] Implementation scheme 36 is a method according to any one of implementation schemes 23 to 35, wherein the one or more reagents penetrate the thickness setting of the porous sample collection medium.

[0199] Implementation scheme 37 is a method according to any one of implementation schemes 23 to 36, wherein the deposition of the one or more reagents includes transferring the one or more reagents from the release surface onto the porous sample collection medium.

[0200] Implementation scheme 38 is a method according to any one of implementation schemes 23 to 36, wherein the deposition of the one or more reagents includes using mechanical grinding to adhere a powder containing the one or more reagents onto the porous sample collection medium.

[0201] Implementation scheme 39 is a method according to any one of implementation schemes 23 to 26, wherein the deposition of the one or more reagents includes depositing a suspension containing the one or more reagents onto the porous sample collection medium.

[0202] Implementation scheme 40 is the method according to implementation scheme 23, wherein the suspension is deposited by inkjet printing, needle transfer, stripe coating, gravure printing, flexographic printing, spraying, screen printing, stencil printing, or a combination of two or more of them.

[0203] Implementation scheme 41 is the method according to any one of implementation schemes 23 to 40, wherein the reagent area includes one or more regions in which the one or more reagents are not present.

[0204] Implementation scheme 42 is a method according to any one of implementation schemes 23 to 41, wherein the porous sample collection medium is configured to collect aerosolized particles.

[0205] Implementation scheme 43 is a method according to any one of implementation schemes 23 to 42, wherein the porous sample collection medium is configured to release collected aerosolized particles upon contact with a buffer solution.

[0206] Implementation scheme 44 is a method according to any one of implementation schemes 23 to 43, wherein the housing includes a nozzle or nose-shaped member, and wherein the air inlet extends through the nozzle or nose-shaped member.

[0207] Implementation scheme 45 is a method according to any one of implementation schemes 23 to 44, wherein the system includes a liquid reservoir.

[0208] Implementation scheme 46 is the method according to any one of implementation schemes 45, wherein the liquid reservoir is disposed within the housing.

[0209] Implementation scheme 47 is the method according to any one of implementation schemes 45, wherein the liquid reservoir is capable of being coupled to the housing.

[0210] Implementation scheme 48 is a method according to any one of implementation schemes 45 to 47, wherein the liquid reservoir contains a metered dose of liquid.

[0211] Implementation scheme 49 is the method according to implementation scheme 48, wherein the measured dose of liquid has a volume in the range of 50 μL to 1500 μL or 100 μL to 1000 μL.

[0212] Implementation scheme 50 is the method according to implementation scheme 48, wherein the porous sample collection medium defines a surface area and the metered dose of liquid has a volume, and wherein the volume divided by the surface area is in the range of 10 μL / cm². 2 Up to 400 μL / cm 2 or 10 μL / cm 2 Up to 250 μL / cm 2 .

[0213] Embodiment 51 is a method according to any one of embodiments 48 to 50, wherein the metered dose of liquid comprises an aqueous solution, optionally a buffer solution, and optionally contains a surfactant.

[0214] Implementation scheme 52 is a method according to any one of implementation schemes 23 to 51, wherein the testing device includes a lateral flow testing device (“LFA”) or a vertical flow testing device (“VFA”).

[0215] Implementation scheme 53 is a method according to any one of implementation schemes 23 to 52, wherein the assay device is configured to detect the presence of viruses, bacteria, fungi, pathogens, biomarkers, biomolecules, metabolites or other analytes.

[0216] Implementation scheme 54 is the method according to any one of implementation schemes 23 to 53, wherein the housing includes a test result display window.

[0217] Embodiment 55 is a method according to any one of Embodiments 23 to 54, wherein the one or more reagents include one or more labeling reagents, optionally wherein the one or more reagents include antibodies conjugated with gold nanoparticles (e.g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots) or combinations of two or more of them.

[0218] Implementation scheme 56 is a method for analyzing bioaerosol samples, the method comprising:

[0219] Exhaled air is circulated through a porous sample collection medium to form a captured sample, the porous sample collection medium comprising one or more reagents disposed in a reagent area;

[0220] A metered dose of liquid is released from a liquid reservoir onto the porous sample collection medium to elute the captured sample and at least some of the one or more reagents, thereby forming a liquid reaction mixture.

[0221] The liquid reaction mixture is allowed to flow onto a testing apparatus, in which the captured sample and at least some of the one or more reagents react to display an indicator of the test result; and

[0222] Observe the indicator sign for the test result.

[0223] Implementation scheme 57 is the method according to implementation scheme 56, wherein the porous sample collection medium, the liquid reservoir, and the testing device form a sample collection system, the sample collection system comprising:

[0224] The housing includes an air inlet configured to receive the exhaled air;

[0225] The porous sample collection medium is disposed within the housing and includes a sample receiving area;

[0226] An airflow passage extends from the air inlet through the sample receiving area of ​​the porous sample collection medium;

[0227] Laboratory equipment; and

[0228] A liquid flow path extends from the sample receiving area of ​​the porous sample collection medium to the testing device.

[0229] Implementation scheme 58 is the method according to implementation scheme 56 or 57, wherein the one or more reagents are disposed on the outer surface of the porous sample collection medium.

[0230] Implementation scheme 59 is the method according to implementation scheme 57 or 58, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the assay device, and wherein the one or more reagents are disposed downstream of the sample receiving area along the liquid flow path.

[0231] Implementation 60 is a method according to any one of Implementations 57 to 59, wherein the liquid flow path extends from the liquid inlet to the reaction area of ​​the assay device, and wherein the one or more reagents are disposed upstream of the sample receiving area along the liquid flow path.

[0232] Implementation scheme 61 is a method according to any one of implementation schemes 57 to 60, wherein the one or more reagents are provided to penetrate the thickness of the porous sample collection medium.

[0233] Implementation scheme 62 is a method according to any one of implementation schemes 57 to 61, wherein the one or more reagents are arranged in a pattern.

[0234] Implementation scheme 63 is a method according to any one of implementation schemes 57 to 62, wherein the reagent area includes one or more regions in which the one or more reagents are not present.

[0235] Implementation scheme 64 is a method according to any one of implementation schemes 57 to 43, wherein the porous sample collection medium is configured to collect aerosolized particles.

[0236] Embodiment 65 is a method according to any one of embodiments 57 to 64, wherein the porous sample collection medium is configured to release collected aerosolized particles upon contact with a buffer solution.

[0237] Embodiment 66 is a method according to any one of embodiments 57 to 65, wherein the housing includes a nozzle or nose-shaped element, and wherein the air inlet extends through the nozzle or nose-shaped element.

[0238] Implementation scheme 67 is the method according to any one of implementation schemes 57 to 66, wherein the liquid reservoir is disposed within the housing.

[0239] Implementation scheme 68 is the method according to any one of implementation schemes 57 to 67, wherein the liquid reservoir is capable of being coupled to the housing.

[0240] Implementation scheme 69 is a method according to any one of implementation schemes 57 to 68, wherein the liquid reservoir contains a metered dose of liquid.

[0241] Implementation scheme 70 is the method according to implementation scheme 69, wherein the measured dose of liquid has a volume in the range of 50 μL to 1500 μL or 100 μL to 1000 μL.

[0242] Implementation scheme 71 is the method according to implementation scheme 69, wherein the porous sample collection medium defines a surface area and the metered dose of liquid has a volume, and wherein the volume divided by the surface area is in the range of 10 μL / cm². 2 Up to 400 μL / cm 2 or 10 μL / cm 2 Up to 250 μL / cm 2 .

[0243] Embodiment 72 is a method according to any one of embodiments 69 to 71, wherein the metered dose of liquid comprises an aqueous solution, optionally a buffer solution, and optionally contains a surfactant.

[0244] Implementation scheme 73 is a method according to any one of implementation schemes 56 to 72, wherein the testing device includes a lateral flow testing device (“LFA”) or a vertical flow testing device (“VFA”).

[0245] Implementation scheme 74 is a method according to any one of implementation schemes 56 to 73, wherein the assay device is configured to detect the presence of viruses, bacteria, fungi, pathogens, biomarkers, biomolecules, metabolites or other analytes.

[0246] Implementation scheme 75 is the method according to any one of implementation schemes 57 to 74, wherein the housing includes a test result display window.

[0247] Implementation scheme 76 is a method according to any one of implementation schemes 56 to 75, wherein the one or more reagents include one or more labeling reagents, optionally wherein the one or more reagents include antibodies conjugated with gold nanoparticles (e.g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots) or combinations of two or more of them.

[0248] Implementation scheme 77 is a method according to any one of implementation schemes 56 to 76, wherein the indicator for observing the test result includes visual observation of the indicator.

[0249] Implementation scheme 78 is a method according to any one of implementation schemes 56 to 76, wherein the indicator for observing the test result includes using an instrument, optionally a colorimeter, to observe the indicator.

[0250] Implementation scheme 79 is a reagent kit, which includes:

[0251] A sample collection and analysis system, comprising:

[0252] The housing includes an air inlet configured to receive exhaled airflow;

[0253] A porous sample collection medium disposed within the housing, the porous sample collection medium including a sample receiving area;

[0254] An airflow passage extends from the air inlet through the sample receiving area of ​​the porous sample collection medium;

[0255] A testing apparatus configured to receive eluted samples from the porous sample collection medium; and

[0256] A liquid flow path extends from the sample receiving area of ​​the porous sample collection medium to the testing device.

[0257] The porous sample collection medium includes one or more reagents disposed along the liquid flow path on the porous sample collection medium; and

[0258] Instructions for collecting samples and testing them using the testing apparatus.

[0259] Implementation scheme 80 is a kit according to implementation scheme 79, wherein the instructions include instructions for operating: exhaling along the airflow pathway to capture a sample in the porous sample collection medium; releasing a metered dose of liquid onto the porous sample collection medium; and observing the test results in the results display of the assay device, optionally reading the test results display of the assay device using an electronic reader.

[0260] Embodiment 81 is a sample collection and analysis system according to any one of embodiments 1 to 22, wherein the metered dose of liquid is stored in a blister pack or bag within the housing, the blister pack or bag being configured to rupture and release the metered dose of liquid onto the porous sample collection medium material.

[0261] Implementation scheme 82 is a sample collection and analysis system according to implementation scheme 81, wherein the blister pack includes a ruptureable material and the blister pack is disposed between the air inlet and the detection zone.

[0262] Implementation scheme 83 is a sample collection and analysis system according to implementation scheme 81 or 82, wherein the blister pack is disposed on a nesting member, the nesting member including a plurality of puncture elements extending upward toward the bottom of the blister pack, a central bowl, an opening extending through the central bowl, and a vent.

[0263] Implementation scheme 84 is a sample collection and analysis system according to implementation scheme 83, wherein the measured dose of liquid is released through the opening of the central bowl.

[0264] Implementation scheme 85 is a sample collection and analysis system according to implementation scheme 81, wherein the blister pack or bag is arranged to be contacted by a hinged wing to puncture the blister pack and release the metered dose of liquid.

[0265] Implementation scheme 86 is a sample collection and analysis system according to implementation scheme 85, wherein the hinged wing is folded onto the housing to push the blister pack and cause it to break.

[0266] Implementation scheme 87 is a sample collection and analysis system according to implementation scheme 81, wherein the blister pack or bag is arranged to be contacted by a movable hinge assembly to cause the blister pack to break.

[0267] Embodiment 88 is a sample collection and analysis system according to Embodiment 87, wherein the movable hinge assembly is aligned with the blister pack and includes a plurality of movable hinges, the plurality of piston hinges being configured to detach from the movable hinge assembly and rupture the blister pack.

[0268] Implementation scheme 89 is a sample collection and analysis system according to implementation scheme 15, wherein the measured dose of liquid contains a surfactant.

[0269] Embodiment 90 is a sample collection and analysis system according to Embodiment 89, wherein the surfactant is present in the liquid at a concentration of 0.05 wt% or more, 0.075 wt% or more, 0.10 wt% or more, 0.15 wt% or more, or 0.2 wt% or more. The liquid may contain 2 wt% or less, 1.5 wt% or less, 1.25 wt% or less, 1.0 wt% or less, 0.8 wt% or less, or 0.5 wt% or less of surfactant.

[0270] Implementation scheme 91 is a sample collection and analysis system according to implementation scheme 89 or 90, wherein the surfactant is present in the liquid at a concentration of 0.05% to 2% by weight, 0.075% to 1.5% by weight, or 0.1% to 1% by weight.

[0271] Implementation scheme 92 is a sample collection and analysis system according to any one of implementation schemes 89 to 91, wherein the surfactant includes a nonionic surfactant.

[0272] Embodiment 93 is a sample collection and analysis system according to any one of embodiments 89 to 92, wherein the surfactant includes a polysorbate surfactant, an alcohol ethoxylate, or a combination thereof.

[0273] Embodiment 94 is a sample collection and analysis system according to any one of embodiments 89 to 93, wherein the surfactant comprises a combination of two or more nonionic surfactants, optionally wherein the surfactant comprises a combination of two surfactants.

[0274] Embodiment 95 is a sample collection and analysis system according to any one of Embodiments 89 to 94, wherein the surfactant comprises a combination of 25% to 75% by weight of an alcohol ethoxylate and 25% to 75% by weight of polyethylene glycol dehydrated sorbitol monolaurate, based on the total weight of the surfactant.

[0275] All references and publications cited herein are expressly incorporated in their entirety by reference, except where they may directly conflict with this disclosure. While specific embodiments have been illustrated and described herein, those skilled in the art will recognize that various alternative and / or equivalent embodiments may be used instead of the illustrated and described embodiments without departing from the scope of this disclosure. It should be understood that this disclosure is not intended to be unduly limited to the exemplary embodiments and examples shown herein, and such embodiments and examples are presented by way of example only, and the scope of this disclosure is intended to be limited only by the claims set forth herein.

Claims

1. A sample collection and analysis system, the sample collection and analysis system comprising: A housing, the housing including an air inlet configured to receive an exhaled airflow; A porous sample collection medium, wherein the porous sample collection medium is disposed within the housing, and the porous sample collection medium includes a sample receiving area; An airflow passage extends from the air inlet through the sample receiving area of ​​the porous sample collection medium; A testing apparatus configured to receive eluted samples from the porous sample collection medium; as well as A liquid flow path extends from the sample receiving area of ​​the porous sample collection medium to the testing device. The porous sample collection medium includes one or more reagents disposed along the liquid flow path on the porous sample collection medium.

2. The sample collection and analysis system according to claim 1, wherein one or more reagents are disposed on the outer surface of the porous sample collection medium.

3. The sample collection and analysis system according to claim 1 or 2, wherein the one or more reagents penetrate the thickness setting of the porous sample collection medium.

4. The sample collection and analysis system according to any one of the preceding claims, wherein the testing apparatus comprises a conjugate pad containing the conjugate and a detection zone downstream of the conjugate pad.

5. The sample collection and analysis system according to any one of the preceding claims, wherein the liquid flow path extends from the liquid inlet to the detection area of ​​the testing device, and wherein one or more reagents are disposed downstream of the sample receiving area along the liquid flow path.

6. The sample collection and analysis system according to any one of the preceding claims, wherein the liquid flow path extends from the liquid inlet to the detection area of ​​the testing device, and wherein one or more reagents are disposed upstream of the sample receiving area along the liquid flow path.

7. The sample collection and analysis system according to any one of the preceding claims, wherein the one or more reagents are arranged in a pattern.

8. The sample collection and analysis system according to any one of the preceding claims, wherein the one or more reagents are adhered to the porous sample collection medium by an adhesive.

9. A method for manufacturing a sample collection and analysis system, the method comprising: One or more reagents are deposited on a porous sample collection medium to form a reagent zone; The porous sample collection medium is placed inside the housing along an airflow path extending from the air inlet to the sample receiving area on the porous sample collection medium; as well as The testing device is coupled to the housing to form a liquid flow path through the sample receiving area, through the reagent area, and to the testing device or to the testing device.

10. The method of claim 9, wherein one or more reagents are disposed on the outer surface of the porous sample collection medium.

11. The method of claim 9 or 10, wherein the testing apparatus comprises a conjugate pad containing the conjugate and a detection zone downstream of the conjugate pad.

12. The method according to any one of claims 9 to 11, wherein the liquid flow path extends from the liquid inlet to the detection area of ​​the assay apparatus, and wherein one or more reagents are disposed downstream of the sample receiving area along the liquid flow path.

13. The method according to any one of claims 9 to 12, wherein the liquid flow path extends from the liquid inlet to the detection area of ​​the assay apparatus, and wherein one or more reagents are disposed upstream of the sample receiving area along the liquid flow path.

14. The method according to any one of claims 9 to 13, wherein the deposition of the one or more reagents comprises applying a powder containing the one or more reagents onto the porous sample collection medium.

15. The method according to any one of claims 9 to 14, wherein the deposition of the one or more reagents comprises depositing an adhesive onto the porous sample collection medium and adhering a powder containing the one or more reagents to the adhesive.

16. The method of claim 15, wherein the adhesive is deposited in a pattern.

17. The method of claim 15 or 16, wherein the adhesive is applied by inkjet printing, stripe coating, gravure printing, flexographic printing, spraying, screen printing, or a combination of two or more of the above.

18. The method according to any one of claims 9 to 17, wherein the deposition of the one or more reagents comprises charging a region of the porous sample collection medium and adhering a powder containing the one or more reagents to the charged region.

19. The method of claim 18, wherein the charging includes triboelectric charging.

20. The method of claim 18, wherein the charging comprises printing a charged material onto the porous sample collection medium.

21. The method according to any one of claims 9 to 20, wherein the deposition of the one or more reagents comprises applying a powder containing the one or more reagents to one side of the porous sample collection medium and evacuating the opposite side of the porous sample collection medium.

22. The method according to any one of claims 9 to 21, wherein the deposition of the one or more reagents comprises applying a powder containing the one or more reagents onto the porous sample collection medium by powder spraying.

23. The method according to any one of claims 9 to 22, wherein the one or more reagents penetrate the thickness setting of the porous sample collection medium.

24. The method according to any one of claims 9 to 23, wherein the deposition of the one or more reagents comprises transferring the one or more reagents from the release surface onto the porous sample collection medium.

25. The method according to any one of claims 9 to 24, wherein the deposition of said one or more reagents comprises using mechanical grinding to adhere a powder containing said one or more reagents onto the porous sample collection medium.

26. The method according to any one of claims 9 to 24, wherein the deposition of said one or more reagents comprises depositing a suspension containing said one or more reagents onto the porous sample collection medium.

27. The method of claim 26, wherein the suspension is deposited by inkjet printing, needle transfer, stripe coating, gravure printing, flexographic printing, spraying, screen printing, stencil printing, or a combination of two or more thereof.

28. The method according to any one of claims 9 to 27, wherein the reagent region includes one or more regions in which the one or more reagents are not present.

29. The method according to any one of claims 9 to 28, wherein the porous sample collection medium is configured to collect aerosolized particles.

30. The method according to any one of claims 9 to 29, wherein the porous sample collection medium is configured to release collected aerosolized particles upon contact with a buffer solution.

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