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WO2025080586A1 - Système de collecte et d'analyse d'échantillons - Google Patents

Système de collecte et d'analyse d'échantillons Download PDF

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Publication number
WO2025080586A1
WO2025080586A1 PCT/US2024/050381 US2024050381W WO2025080586A1 WO 2025080586 A1 WO2025080586 A1 WO 2025080586A1 US 2024050381 W US2024050381 W US 2024050381W WO 2025080586 A1 WO2025080586 A1 WO 2025080586A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample collection
reagents
collection media
porous
porous sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/050381
Other languages
English (en)
Inventor
Michael R. Berrigan
Mikhail L. Pekurovsky
Laura R. NERENG
Shawn C. DODDS
Matthew S. Stay
Kevin T. REDDY
Ann M. GILMAN
Giuseppe De Bellis
Ramasubramani Kuduva Raman Thanumoorthy
Michael C. Wohl
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
3M Innovative Properties Co
Original Assignee
3M Innovative Properties Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 3M Innovative Properties Co filed Critical 3M Innovative Properties Co
Publication of WO2025080586A1 publication Critical patent/WO2025080586A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502769—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by multiphase flow arrangements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0621—Control of the sequence of chambers filled or emptied
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/087—Multiple sequential chambers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0415—Moving fluids with specific forces or mechanical means specific forces electrical forces, e.g. electrokinetic

Definitions

  • Diagnostic tests used to test for the presence of a virus or other pathogen in the airways, throat, or nasopharynx typically involve the insertion of a swab into the back of the nasal passage, the mid-turbinate area of the nasal passage, the anterior nares, mouth, or the throat to obtain a sample. The swab is then inserted into a container and analyzed or sent to a lab for processing. Other diagnostic tests involve collecting a saliva sample and then placing it in a container.
  • NP nasopharyngeal
  • CDC United States Centers for Disease Control and Prevention
  • Sensitivity is a complex issue, however, as detection in the upper airways (nasopharynx and oropharynx) is affected by multiple factors including duration of illness prior to testing, as well as the limit of detection (LoD) of the RT-PCR assay used.
  • Availability of NP swabs and the resources to establish NP collection sites with specimen collection personnel were critical bottlenecks during the pandemic.
  • healthcare systems adopted multiple different strategies, including engaging industrial manufacturers to mass produce novel 3D-printed NP swabs, as well as evaluating different specimen types and alternative samplecollection strategies, such as saliva.
  • the system may be self-contained to allow for disposal of any potential virus or pathogen, as well as any reagents used in testing.
  • the one or more reagents may be disposed throughout a thickness of the porous sample collection media.
  • the one or more reagents may be disposed downstream of the sample receiving region along the liquid flow path.
  • the one or more reagents may be disposed upstream of the sample receiving region along the liquid flow path.
  • the one or more reagents may be disposed in a pattern.
  • a method of making a sample collection and analysis system includes: depositing one or more reagents on a porous sample collection media to form a reagent zone; placing the porous sample collection media within a housing in an airflow path extending from an air inlet to a sample receiving region on the porous sample collection media; and coupling the assay with the housing, forming a liquid flow path through the sample receiving region, through the reagent zone, and onto or into the assay.
  • the one or more reagents may be disposed on an outer surface of the porous sample collection media.
  • the one or more reagents may be disposed throughout a thickness of the porous sample collection media.
  • the one or more reagents may be disposed downstream of the sample receiving region along the liquid flow path.
  • the one or more reagents may be disposed upstream of the sample receiving region along the liquid flow path.
  • the one or more reagents may be disposed in a pattern.
  • the depositing of the one or more reagents may include applying a powder comprising the one or more reagents onto the porous sample collection media by powder jetting.
  • the depositing of the one or more reagents may include transferring the one or more reagents onto the porous sample collection media from a release surface.
  • the depositing of the one or more reagents may include using mechanical abrasion to adhere a powder comprising the one or more reagents onto the porous sample collection media.
  • the depositing of the one or more reagents may include depositing a suspension comprising the one or more reagents onto the porous sample collection media.
  • the reagent zone may include a pattern of the one or more reagents and one or more areas where the one or more reagents are absent.
  • FIG. 2E is a schematic depiction of parts of the sample collection and analysis system of FIG. 1 including a conjugate pad between the sample collection media layer and the assay.
  • FIG. 3 A is a perspective view of a sample collection and analysis system according to an embodiment.
  • FIG. 3B is a cross-sectional perspective view of the sample collection and analysis system of FIG. 3 A.
  • FIG. 5B is a cross-sectional side view of the sample collection and analysis system of FIG. 5 A.
  • FIG. 5C is a partial cross-sectional perspective view of the sample collection and analysis system of FIG. 5 A.
  • FIG. 6B is a top view of the sample collection and analysis system of FIG. 6A.
  • FIG. 8B is partial top sectional perspective view of the internal components of the sample collection and analysis system of FIG. 6A.
  • FIG. 1 ID is an exploded detail view of a blister pack and base of the sample collection and analysis system of FIG. 11A.
  • the sample collection and analysis system of the present disclosure are capable of a clean sample collection and easy testing of samples.
  • the sample collection and analysis system of the present disclosure are capable of capturing and eluting samples that have a low analyte (e.g., pathogen, e.g., viral) load.
  • the sample collection and analysis system of the present disclosure can reliably detect an analyte.
  • the sample collection and analysis system of the present disclosure is capable of enhanced sensitivity in comparison with conventional sample collection and analysis systems.
  • the sample collection and analysis system of the present disclosure can provide repeatable and reliable test results and reduce human error.
  • the porous sample collection media may be formed of polymeric material. Suitable materials for the 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 from about 90 degrees to about 170 degrees, or from about 100 degrees to about 150 degrees.
  • the term “hydrophilic” refers to a material having a water contact angle of less than 90 degrees. Water contact angle is measured using ASTM D5727-1997 Standard test method for surface wettability and absorbency of sheeted material using an automated contact angle tester.
  • the sample collection and analysis system may be configured for analyzing a single analyte.
  • the sample collection and analysis system may be configured for analyzing coronavirus, rhinovirus, norovirus, influenza virus, adenovirus, adeno-associated virus, varicellazoster virus, herpesvirus, retrovirus, papillomavirus, enterovirus, arenavirus, or another type of virus.
  • the sample collection and analysis system may be configured for analyzing two or more analytes.
  • the sample collection and analysis system of the present disclosure includes an assay.
  • the assay may be constructed with a conjugate pad and a membrane with a detection zone thereon.
  • the assay may further include an absorbent overflow pad that facilitates liquid flow through the assay.
  • the assay may be a modified lateral flow assays (LFA) as further described below.
  • suitable LFAs include lateral flow test strips available from Merck Millipore, such as those described in a reference document entitled Rapid Lateral Flow Test Strips Considerations for Product Development (Merck Millipore Lit. No.
  • the assay used in the system of the present disclosure may be similar to the assays described in the reference document except that at least some of the reagents typically included on the conjugate pad are included on the porous sample collection media instead.
  • FIGURE 1 an illustrative schematic of an exemplary sample collection and analysis system 1 is shown.
  • the system 1 includes both sample collection and testing capabilities.
  • the system 1 has a housing 100 and porous sample collection media 130 and an assay 300 disposed within the housing 100.
  • the porous sample collection media includes a sample receiving region 131.
  • One or more reagents are disposed on the porous sample collection media 130 forming a reagent zone 360.
  • the reagent zone 360 is shown as surrounding the sample receiving region 131. However, as further discussed below, the one or more reagents may be disposed upstream or downstream of the sample receiving region 131.
  • the reagent zone 360 may also overlap the sample receiving region 131. In devices where the reagent zone 360 overlaps the sample receiving region 131, it is desirable that the reagent zone 360 allows airflow through it. As further discussed below, the reagent zone 360 may be formed by a pattern of reagents (and optionally adhesive), and may include one or more areas where the one or more reagents are absent.
  • the one or more reagents 360C, 360D are disposed upstream of the sample receiving region 131 along the liquid flow path 230.
  • the one or more reagents e.g., reagent zone 360C, 360D
  • the reagent zone 360C is applied as a dot.
  • the reagent zone 360D is applied as a line. The line may extend across the liquid flow path 230.
  • housing types include a planar support (e.g., a laminated support platform), a sleeve, an envelope, and a tube.
  • the housing may partially or completely encase some or all of the components of the system.
  • the housing may support some or all of the components from one, two, three, or more sides. Exemplary sample collection and analysis systems are further discussed in detail below.
  • the porous sample collection media is a nonwoven material carrying an electrostatic charge.
  • the electrostatic charge may enable capturing pathogens, viruses, or other analytes from an exhalation airflow.
  • the porous sample collection media may be a hydrophobic nonwoven material.
  • the porous sample collection media may be a hydrophilic nonwoven material.
  • the porous sample collection media may be a hydrophobic nonwoven material carrying an electrostatic charge configured to capture pathogens, viruses, or other analytes from an exhalation airflow.
  • the porous sample collection media may be a hydrophilic nonwoven material carrying an electrostatic charge configured to capture pathogens, viruses, or other analytes from an exhalation airflow.
  • the porous sample collection media may be inert. That is, the porous sample collection media may not react with the sample, the one or more reagents, or the liquid. The porous sample collection media does not change when it collects the bioaerosol sample or when the sample is eluted.
  • the porous sample collection media may be configured to release collected aerosolized particles upon contact with the liquid, e.g., with a buffer.
  • the porous sample collection media may be capable of releasing the sample without mechanical agitation or chemical breakdown.
  • the porous sample collection media may have a thickness (orthogonal to the major plane) of 200 pm or greater or 250 pm or greater.
  • the porous sample collection media may have a thickness of 750 pm or less or 1000 pm or less.
  • the porous sample collection media may have a thickness of in a range from 200 pm to 1000 pm, or from 250 pm to 750 pm.
  • the porous sample collection media may have major plane surface area (of one side) of 1 cm 2 or greater or 2 cm 2 or greater.
  • the porous sample collection media may have major plane surface area of 3 cm 2 or less or 4 cm 2 or less.
  • the porous sample collection media may have major plane surface area in a range from 1 cm 2 to 4 cm 2 , or 2 cm 2 to 3 cm 2 .
  • the porous sample collection media 120 may have a thickness (orthogonal to the major plane) in a range from 200 pm to 1000 pm, or from 250 pm to 750 pm.
  • the porous sample collection media 120 may have major plane surface area in a range from about 0.75 cm 2 to about 6 cm 2 , about 1 cm 2 to about 4 cm 2 , about 1 cm 2 to about 3 cm 2 , about 1.5 cm 2 to about 2.5 cm 2 , or about 2 cm 2 to about 3 cm 2 .
  • the one or more reagents may be applied onto the porous sample collection media by any suitable method.
  • the one or more reagents may be disposed on an outer surface of the porous sample collection media.
  • the one or more reagents may be disposed throughout a thickness of the porous sample collection media.
  • Suitable methods for applying the one or more reagents onto the porous sample collection media include methods of applying a powder containing the one or more reagents onto the porous sample collection media.
  • the porous sample collection media may first be treated in a way that allows the powder to adhere to the porous sample collection media.
  • an adhesive may be first applied to the porous sample collection media and the powder may be applied onto the adhesive.
  • the adhesive may be deposited as a dot, line, or any other shape, or in a pattern.
  • the adhesive may be applied by inkjet printing, stripe coating, gravure printing, fl exo printing, spraying, screen printing, or a combination of two or more thereof.
  • the porous sample collection media may be treated to have an electric charge onto which the powder may adhere.
  • the porous sample collection media may be charged by tribo electric charging or by printing a charged substance onto the porous sample collection media.
  • the porous sample collection media may be charged by printing a charged substance onto the porous sample collection media.
  • the charged area may be applied as a dot, line, or any other shape, or in a pattern.
  • a powder containing the one or more reagents is applied to and adheres to the electrically charged area. Excess powder may be removed, e.g., by vacuum, blowing, brushing, or allowing the excess powder to fall off.
  • the one or more reagents are applied throughout the thickness of the porous sample collection media.
  • the one or more reagents may be applied as a powder onto the surface of the porous sample collection media and, by drawing a vacuum from the opposite side of the porous sample collection media, suctioned into the thickness of the porous sample collection media.
  • the one or more reagents may be applied as a powder by powder jetting.
  • the powder jet may have a velocity that delivers at least some of the powder into the thickness of the t porous sample collection media.
  • the one or more reagents are applied onto the porous sample collection media by using mechanical abrasion to adhere a powder comprising the one or more reagents onto the porous sample collection media.
  • the porous sample collection media may optionally be treated by applying an adhesive or an electric charge prior to application of the reagent.
  • the one or more reagents may be applied onto the porous sample collection media in any suitable shape or pattern, such as a dot, line, or any other shape.
  • a pattern is understood to mean a plurality of shapes, such as a plurality of dots, lines, or other shapes.
  • the one or more reagents may form a reagent zone on the porous sample collection media.
  • the reagent zone includes one or more areas where the one or more reagents are absent. For example, when the one or more reagents is applied in a pattern to form the reagent zone, within the pattern there may be areas where the one or more reagents are absent.
  • a method of making the sample collection and analysis system may include depositing the one or more reagents on the porous sample collection media to form a reagent zone, placing the porous sample collection media within a housing in an airflow path extending from an air inlet to a sample receiving region on the porous sample collection media, and coupling an assay with the housing, forming a liquid flow path through the sample receiving region, through the reagent zone, and onto or into the assay.
  • the sample collection and analysis system may further include elements that facilitate sample collection, such as a mouthpiece or nosepiece or another structure that facilitates breathing into the airflow path.
  • a mouthpiece For convenience, reference is made here to a mouthpiece but it should be understood that the structure may also be a nosepiece or other suitable structure.
  • the mouthpiece may be aligned with an inlet opening. The mouthpiece may help a user direct exhalation airflow onto the porous sample collection media.
  • the mouthpiece may be integral with the housing or may be removably coupled with the housing. Alternatively, the sample may be loaded onto the porous sample collection media separately (e.g., by using a separate sample collection device), and the loaded porous sample collection may be placed within the housing of the system.
  • the sample collection and analysis system may include a liquid reservoir.
  • the liquid reservoir may contain a metered dose of liquid.
  • the liquid reservoir may be provided as a separate element or may be integrated into the housing. If provided as a separate element, the liquid reservoir may be used to apply a metered dose of liquid onto the porous sample collection media manually (e.g., by using a dropper), or the liquid reservoir may be couplable with a receptacle on the housing.
  • the liquid reservoir may be disposed within the housing.
  • the liquid reservoir may be formed by the housing itself or may be provided as a liquid capsule disposed within the housing.
  • the liquid reservoir may be constructed to release a metered dose of liquid onto the porous sample collection media.
  • a removable tab may removably seal the liquid reservoir.
  • the removable tab may be sealed onto the opening of the liquid reservoir by a peelable seal.
  • the liquid 201 dispensed onto the porous sample collection media may be an aqueous liquid.
  • the liquid may be a buffer solution.
  • the liquid may be an aqueous buffer solution.
  • the liquid may be a saline solution.
  • the liquid may be a wetting liquid.
  • the liquid may include a surfactant.
  • a “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, as well as flow through or across the porous sample collection media and onto the assay. For example, the surface tension of the liquid may be lower than that of water.
  • the liquid may have a contact angle of greater than 90 degrees when measured on the porous sample collection media.
  • the liquid may be a saline solution including a surfactant.
  • the surfactant may be included in an amount that has the desired effect on the surface tension, which varies by surfactant.
  • the liquid may include one or more surfactants at a concentration of 0.05 wt-% to 2 wt-%, 0.075 wt-% to 1.5 wt-%, or from 0.1 wt-% to 1 wt-%.
  • the liquid consists of water and one or more surfactants.
  • the porous sample collection media defines a major surface area and the metered dose of liquid defines a volume, and the volume divided by the surface area may be in a range from 10 pL/cm 2 to 400 pL /cm 2 , or from 10 pL/cm 2 to 250 pL/cm 2 , or from 50 pL/cm 2 to 150 pL/cm 2 .
  • the liquid may be applied onto the loaded porous sample collection media.
  • the liquid may travel through the surface and thickness of the loaded porous sample collection media and elute any virus, pathogen, or other analyte, that was present on the loaded porous sample collection media, and the one or more reagents, forming a mixture of liquid, sample, and one or more reagents (e.g., a liquid reaction mixture).
  • the mixture may flow off of the porous sample collection media and onto the assay. This mixture may then be received by the detection zone of the assay and be tested for the presence of the virus, pathogen, or other analyte of interest.
  • a liquid sample is placed on the assay in a sample receiving region and is wicked by capillary flow along the device to a detection zone.
  • LFAs and VFAs are typically based on antigens or antibodies that are immobilized in the detection zone and that selectively react with the analyte of interest. The result is typically displayed within 5 to 30 minutes. LFAs and VFAs can be tailored for the testing of a variety of viruses and other pathogens, as well as many other types of analytes.
  • the assay used in the sample collection and analysis system of the present disclosure is constructed for the detection of a target virus, target pathogen, or other target analyte.
  • colorimetric indicators include LFA colorimetric readers utilizing image sensors, such as a charge-coupled device (CCD) or complementary metal oxide semiconductor (CMOS). Such devices are useful, at least in part, due to their simple structure and small size.
  • the LFA develops a test line, which is an aggregate of labeled particles, antigens, and antibodies.
  • An image sensor-based LFA reader acquires an image of the test line analyzes the pixel intensity of the test line, which changes according to the concentration of the target analyte.
  • the system 1001 further includes an assay 1300 for receiving the sample to analyze the analyte of interest.
  • the assay 1300 is housed within the housing 1110.
  • the assay 1300 may be disposed in the second part 1102 of the housing 1110.
  • the assay 1300 includes a detection zone 1310 positioned to receive a liquid reaction mixture and where 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 media 1130 to the assay 1300 and the detection zone 1310. Test result appears at a result display area 1370. The result may be viewed through a viewing window 1270 of the housing 1110.
  • a removable tab 4250 is positioned between the opening 4220 and the porous sample collection media 4130.
  • the liquid reservoir 4200 overlaps the porous sample collection media 4130.
  • the liquid reservoir 4200 may be in fluid communication with (e.g., adjacent or immediately adjacent) the porous sample collection media 4130 such that liquid from the liquid reservoir 4200 flows onto the porous sample collection media 4130.
  • the liquid reservoir 4200 may include a capsule 4210 disposed within the conical protrusion 4121, housing the liquid.
  • the volume V4200 of the liquid reservoir 4200 may be defined by the capsule 4210.
  • the capsule 4210 may be removably sealed with the tab 4250.
  • the sealed capsule 4210 may be placed inside the conical protrusion 4121.
  • the removable tab 4250 may include a first portion 4251 and a second portion 3452.
  • the first portion 4251 may be a sealing portion disposed against (e.g., sealed onto) the opening 4220.
  • the second portion 4252 may extend out from the housing 4100 and may form a pull tab. A user may pull on the second portion 4252 to release the metered dose of liquid.
  • the system 4001 further includes an assay 4300 disposed within the housing 4100.
  • the assay 4300 may be constructed to receive a liquid reaction mixture (including eluted sample and one or more reagents) from the conjugate pad 4330 the porous sample collection media 4130.
  • the porous sample collection media 4130 and assay 4300 assembly is shown in FIGURE 9.
  • the assay includes a conjugate pad 4330 and a membrane 4301 including a detection zone 4310 positioned to receive the liquid reaction mixture.
  • the liquid reaction mixture may react with additional reagents on the conjugate pad 4330.
  • the liquid reaction mixture may further react with additional reagents in the detection zone 4310.
  • the conjugate pad 4330 may overlap with the porous sample collection media 4130.
  • the pressure tab 4400 is positioned downstream of the reagent 4360.
  • the distance from the capsule 4210 to the pressure tab 4400 may be measured by distance D4400.
  • the distance D4400 may be any suitable distance to facilitate elution of the sample, dissolving of the reagent 4360, and flowing of the sample and reagent to the detection zone 4310. A distance that is too short may not allow for enough time for elution of the sample and/or dissolving of the reagent, while a distance too long may not be effective to facilitate flow to conjugate pad 4330 and the membrane 4301. Suitable distances D4400 may depend on the particular configuration and placement of the porous sample collection media 4130, conjugate pad 4330, and the membrane 4301.
  • the nest 5270 may include a plurality of piercing 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 a foil or other rupturable material.
  • the nest 5270 may further include an opening 5272 through which the metered dose of liquid may pass from the liquid reservoir (blister pack) 5210 onto the porous sample collection media 5130.
  • the opening 5272 may be positioned in 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 is released.
  • the vent 5273 may extend from the center bowl 5274 of the nest 5270 to the outside of the nest 5270 through its side.
  • the blister pack or pouch may be pushed using a hinged flap to rupture the blister pack.
  • the system 600 which may be otherwise similar to the system 5001 shown in FIGURE 11A-11C, includes a hinged flap 6700 that is aligned with the liquid reservoir 6210 (e.g., blister pack or pouch).
  • the hinged flap 6700 may be folded over the housing 6100 to push against and rupture the liquid reservoir 6210.
  • the hinged flap 6700 may include a protrusion 6701 that aligns with the liquid reservoir 6210.
  • the sample collection and analysis system may further include a machine-readable optical label.
  • Such labels may include, for example, a bar code and a QR (quick response) code.
  • the machine-readable optical label may be configured to display the result of the assay.
  • the machine-readable optical label may be used to read and record the result.
  • An electronic reader capable of reading machine-readable optical labels may be used to read and record the result.
  • An electronic reader may be, for example, a smart phone, a tablet, a laptop, or bar code reader or QR code reader.
  • the electronic reader may further be used to transmit the result, for example, to a healthcare provider or to a database.
  • the housing may be formed of a rigid material, such as plastic or a paper-based material such as cardboard or cardstock.
  • the housing is made of plastic.
  • the housing may be made of a material that does not absorb any of the liquid or eluent.
  • the housing may be made of a hydrophobic material.
  • at least a portion of the housing is transparent.
  • the housing may include transparent material in an area of a result display of the assay.
  • the housing may include a viewing window (either transparent material or an opening) in the area of the result display.
  • the entire housing may be made of a transparent material.
  • the housing may further include a cover or sealing layer constructed to prevent contamination before or after use of the system.
  • the cover or sealing layer may be removable (e.g., may be removed before use).
  • the cover or sealing layer may be closable and/or re-closable (e.g., may be closed after use).
  • the housing may include a pre-filter or screen disposed in the airflow path in front (upstream) of the porous sample collection media.
  • the screen may be constructed to catch larger particles (larger than viruses or pathogens) and prevent such particles from reaching the porous sample collection media.
  • the exhalation airflow passes through a thickness of the pre-filter or screen.
  • the pre-filter or screen at least partially occludes the air flow path.
  • the pre-filter or screen may have a major plane that is orthogonal to the direction of the exhalation airflow passing through the thickness of the pre-filter or screen.
  • the pre-filter or screen may be a non-woven layer configured to filter out larger particles from the exhalation airflow passing through the pre-filter or screen.
  • the pre-filter or screen may be a non-woven layer that does not have an electrostatic charge. In some embodiments, the pre-filter or screen does not capture significant amounts of viral material, pathogen material, or other analyte material, and instead allows them to transmit through the pre-filter or screen. In some embodiments, the prefilter or screen is made of or includes at least one of a plastic mesh, a woven net, a needle-tacked fibrous web, a knitted mesh, an extruded net, and/or a carded or spunbond coverstock.
  • the user may exhale into the sample collection device and load the porous sample collection media with a sample of the exhalation airflow to form a loaded porous sample collection media.
  • the user may exhale through the air inlet or through the mouthpiece or nosepiece.
  • the housing may be constructed such that by exhaling through the single opening, air inlet, mouthpiece, or nosepiece, the exhalation airflow passes through the porous sample collection media.
  • the porous sample collection media is constructed to capture viruses, other pathogens, or other analytes, from the exhalation airflow.
  • the user may then release a metered dose of liquid from the liquid reservoir to apply the liquid to the loaded porous sample collection media and to elute the captured sample and the one or more reagents disposed on the porous sample collection media onto the assay.
  • the user may test the eluent for the presence of a virus, pathogen, or other analyte using the assay. The testing may take place with the loaded porous sample collection media in place in the sample collection and analysis system.
  • a method of using the sample collection and analysis system may include exhaling into the air inlet (e.g., into the mouthpiece) to capture a sample in the porous sample collection media, forming a loaded porous sample collection media; at least partially removing (or moving) the removable tab to release a metered dose of liquid onto the porous sample collection media, thus eluting the sample and the one or more reagents from the loaded porous sample collection media, and allowing the eluted sample to flow onto the assay; and observing a test result in the result display of the assay.
  • the method may further include reading the result display of the assay using an electronic reader.
  • the sample collection and analysis system forms a singular self-contained unit.
  • Providing a self-contained unit allows for convenient shipping and transportation of the sample collection and analysis system and for disposal after use.
  • the self- contained unit may have a compact size and may be conveniently carried in a pocket or purse.
  • the self-contained unit may be safely disposed of after use among ordinary waste disposal.
  • the sample collection and analysis system may be provided as a kit.
  • the kit may include the sample collection and analysis system as discussed above, and instructions for collecting a sample and testing the sample using the assay.
  • the instructions may include instructions to: exhale along the airflow path to capture a sample in the porous sample collection media; move or remove the removable tab to release a metered dose of liquid onto the porous sample collection media; and observe a test result in a result display of the assay.
  • the instructions may further include instructions to read a test result display of the assay using an electronic reader.
  • Tests were conducted to evaluate suitability of different surfactants for use in the device to elute the sample, dissolve the reagent, and transfer the sample and reagent into the detection zone of the assay.
  • To test the prepare liquids only the base of the housing with the assay and sample collection media were used, as shown in FIGURE 8A, without the liquid reservoir 4200.
  • the sample collection media was PLA media having a basis weight in a range of 68-94 g/m 2 .
  • the tested surfactants included SPAN® 20, BIO-SOFT® GSB-9, TWEEN® 20, and combinations of BIO-SOFT® GSB-9 and TWEEN® 20.
  • the surfactants were mixed with water at concentrations ranging from 0.5 wt-% (all surfactants) to 1.5 wt-% (SPAN® 20 and BIO- SOFT® GSB-9) or to 2 wt-% (TWEEN® 20).
  • liquids were applied by pipette in measured doses ranging from 150 pL to 250 pL. Each test was repeated at least 10 and up to 42 times.
  • TWEEN® 20 produced the strongest control lines, while BIO- SOFT® GSB-9 and SPAN® 20 both produced faint control lines. It was observed that BIO- SOFT® GSB-9 had the best wetting performance, followed by TWEEN® 20 and then SPAN® 20. TWEEN® 20 at l-wt% and SPAN® 20 at both 1 wt-% and 1.5 wt-% resulted in leaks, indicating slow absorption into the PLA. It was observed that BIO-SOFT® GSB-9 and TWEEN® 20 performed better at moving the detector from the conjugate pad with less streaking or smearing. It was further observed that the best overall performance could be achieved with a 50/50 combination of BIO-SOFT® GSB-9 and TWEEN® 20.
  • the sample collection and analysis device shown in FIGURES 6A-10 was tested for suitability for detecting COVID-19.
  • Four COVID-19 positive test subjects were instructed to exhale through the nose into the airflow path of the device to capture a sample in the porous sample collection media.
  • the test subjects exhaled five times into the device from each nostril.
  • the test subjects were further instructed to remove the pull tab to release the liquid onto the sample collection media. After about five minutes, it was observed that each of the four test subjects had a positive result in the detection zone of the device. It was concluded that the device was suitable for collecting and analyzing nasal exhalation samples for detecting COVID- 19.
  • Embodiment 2 is the sample collection and analysis system of embodiment 1, wherein the one or more reagents are disposed on an outer surface of the porous sample collection media.
  • Embodiment 3 is the sample collection and analysis system of embodiment 1 or 2, wherein the one or more reagents are disposed throughout a thickness of the porous sample collection media.
  • Embodiment 5 is the sample collection and analysis system of any one of the preceding embodiments, wherein the liquid flow path extends from a liquid inlet to a reaction region of the assay, and wherein the one or more reagents are disposed upstream of the sample receiving region along the liquid flow path.
  • Embodiment 6 is the sample collection and analysis system of any one of the preceding embodiments, wherein the one or more reagents are disposed in a pattern.
  • Embodiment 8 is the sample collection and analysis system of any one of the preceding embodiments, wherein the housing comprises a mouthpiece or nosepiece and wherein the air inlet extends through the mouthpiece or nosepiece.
  • Embodiment 9 is the sample collection and analysis system of any one of the preceding embodiments, wherein the system comprises a liquid reservoir.
  • Embodiment 10 is the sample collection and analysis system of embodiment 9, wherein the liquid reservoir is disposed within the housing.
  • Embodiment 11 is the sample collection and analysis system of embodiment 9, wherein the liquid reservoir is couplable with the housing.
  • Embodiment 12 is the sample collection and analysis system of any one of embodiments 9 to 11, wherein the liquid reservoir contains a metered dose of liquid.
  • Embodiment 13 is the sample collection and analysis system of embodiment 12, wherein the metered dose of liquid has a volume in a range of 50 pL to 1500 pL or 100 pL to 1000 pL.
  • Embodiment 14 is the sample collection and analysis system of embodiment 12, wherein the porous sample collection media defines a surface area and the metered dose of liquid has a volume, and wherein the volume divided by the surface area is in a range from 10 pL/cm 2 to 400 pL/cm 2 , or from 10 pL/cm 2 to 250 pL/cm 2 .
  • Embodiment 15 is the sample collection and analysis system of any one of embodiments 12 to 14, wherein the metered dose of liquid comprises an aqueous solution, optionally a buffer, optionally comprising a surfactant.
  • Embodiment 17 is the sample collection and analysis system of any one of the preceding embodiments, wherein the assay is constructed to detect presence of a virus, bacteria, fungus, pathogen, biomarker, biomolecule, metabolite, or other analyte.
  • Embodiment 19 is the sample collection and analysis system of any one of the preceding embodiments, wherein the one or more reagents comprise one or more labelling reagents, optionally wherein the one or more reagents comprise antibodies conjugated to gold nanoparticles (e.g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), or a combination of two or more thereof.
  • Embodiment 20 is the sample collection and analysis system of any one of the preceding embodiments, wherein the porous sample collection media comprises a nonwoven filtration layer having an electrostatic charge.
  • Embodiment 23 is a method of making a sample collection and analysis system, the method comprising: depositing one or more reagents on a porous sample collection media to form a reagent zone; placing the porous sample collection media within a housing in an airflow path extending from an air inlet to a sample receiving region on the porous sample collection media; and coupling an assay with the housing, forming a liquid flow path through the sample receiving region, through the reagent zone, and onto or into the assay.
  • Embodiment 24 is the method of embodiment 23, wherein the one or more reagents are disposed on an outer surface of the porous sample collection media.
  • Embodiment 25 is the method of embodiment 23 or 24, wherein the liquid flow path extends from a liquid inlet to a reaction region of the assay, and wherein the one or more reagents are disposed downstream of the sample receiving region along the liquid flow path.
  • Embodiment 26 is the method of any one of embodiments 23 to 25, wherein the liquid flow path extends from a liquid inlet to a reaction region of the assay, and wherein the one or more reagents are disposed upstream of the sample receiving region along the liquid flow path.
  • Embodiment 27 is the method of any one of embodiments 23 to 26, wherein the depositing of the one or more reagents comprises applying a powder comprising the one or more reagents onto the porous sample collection media.
  • Embodiment 28 is the method of any one of embodiments 23 to 27, wherein the depositing of the one or more reagents comprises depositing an adhesive onto the porous sample collection media and adhering a powder comprising the one or more reagents to the adhesive.
  • Embodiment 29 is the method of embodiment 28, wherein the adhesive is deposited in a pattern.
  • Embodiment 30 is the method of 28 or 29, wherein the adhesive is applied by inkjet printing, stripe coating, gravure printing, flexo printing, spraying, screen printing, or a combination of two or more thereof.
  • Embodiment 31 is the method of any one of embodiments 23 to 30, wherein the depositing of the one or more reagents comprises charging an area of the porous sample collection media and adhering a powder comprising the one or more reagents to the charged area.
  • Embodiment 32 is the method of embodiment 31, wherein the charging comprises tribo electric charging.
  • Embodiment 33 is the method of embodiment 31, wherein the charging comprising printing a charged substance onto the porous sample collection media.
  • Embodiment 36 is the method of any one of embodiments 23 to 35, wherein the one or more reagents are disposed throughout a thickness of the porous sample collection media.
  • Embodiment 37 is the method of any one of embodiments 23 to 36, wherein the depositing of the one or more reagents comprises transferring the one or more reagents onto the porous sample collection media from a release surface.
  • Embodiment 38 is the method of any one of embodiments 23 to 36, wherein the depositing of the one or more reagents comprises using mechanical abrasion to adhere a powder comprising the one or more reagents onto the porous sample collection media.
  • Embodiment 39 is the method of any one of embodiments 23 to 26, wherein the depositing of the one or more reagents comprises depositing a suspension comprising the one or more reagents onto the porous sample collection media.
  • Embodiment 40 is the method of embodiment 23, wherein the suspension is deposited by inkjet printing, pin transfer, stripe coating, gravure printing, fl exo printing, spraying, screen printing, stenciling, or a combination of two or more thereof.
  • Embodiment 41 is the method of any one of embodiments 23 to 40, wherein the reagent zone comprises one or more areas where the one or more reagents are absent.
  • Embodiment 44 is the method of any one of embodiments 23 to 43, wherein the housing comprises a mouthpiece or nosepiece and wherein the air inlet extends through the mouthpiece or nosepiece.
  • Embodiment 46 is the method of any one of embodiment 45, wherein the liquid reservoir is disposed within the housing.
  • Embodiment 50 is the method of embodiment 48, wherein the porous sample collection media defines a surface area and the metered dose of liquid has a volume, and wherein the volume divided by the surface area is in a range from 10 pL/cm 2 to 400 pL/cm 2 , or from 10 pL/cm 2 to 250 pL/cm 2 .
  • Embodiment 52 is the method of any one of embodiments 23 to 51, wherein the assay comprises a lateral flow assay (“LFA”) or vertical flow assay (“VFA”).
  • LFA lateral flow assay
  • VFA vertical flow assay
  • Embodiment 53 is the method of any one of embodiments 23 to 52, wherein the assay is constructed to detect presence of a virus, bacteria, fungus, pathogen, biomarker, biomolecule, metabolite, or other analyte.
  • Embodiment 54 is the method of any one of embodiments 23 to 53, wherein the housing comprises a test result display window.
  • Embodiment 55 is the method of any one of embodiments 23 to 54, wherein the one or more reagents comprise one or more labelling reagents, optionally wherein the one or more reagents comprise antibodies conjugated to gold nanoparticles (e g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), or a combination of two or more thereof.
  • the one or more reagents comprise antibodies conjugated to gold nanoparticles (e g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), or a combination of two or more thereof.
  • Embodiment 58 is the method of embodiment 56 or 57, wherein the one or more reagents are disposed on an outer surface of the porous sample collection media.
  • Embodiment 59 is the method of embodiment 57 or 58, wherein the liquid flow path extends from a liquid inlet to a reaction region of the assay, and wherein the one or more reagents are disposed downstream of the sample receiving region along the liquid flow path.
  • Embodiment 60 is the method of any one of embodiments 57 to 59, wherein the liquid flow path extends from a liquid inlet to a reaction region of the assay, and wherein the one or more reagents are disposed upstream of the sample receiving region along the liquid flow path.
  • Embodiment 61 is the method of any one of embodiments 57 to 60, wherein the one or more reagents are disposed throughout a thickness of the porous sample collection media.
  • Embodiment 62 is the method of any one of embodiments 57 to 61, wherein the one or more reagents are disposed in a pattern.
  • Embodiment 65 is the method of any one of embodiments 57 to 64, wherein the porous sample collection media is configured to release collected aerosolized particles upon contact with a buffer.
  • Embodiment 66 is the method of any one of embodiments 57 to 65, wherein the housing comprises a mouthpiece or nosepiece and wherein the air inlet extends through the mouthpiece or nosepiece.
  • Embodiment 67 is the method of any one of embodiments 57 to 66, wherein the liquid reservoir is disposed within the housing.
  • Embodiment 69 is the method of any one of embodiments 57 to 68, wherein the liquid reservoir contains a metered dose of liquid.
  • Embodiment 70 is the method of embodiment 69, wherein the metered dose of liquid has a volume in a range of 50 pL to 1500 pL or 100 pL to 1000 pL.
  • Embodiment 71 is the method of embodiment 69, wherein the porous sample collection media defines a surface area and the metered dose of liquid has a volume, and wherein the volume divided by the surface area is in a range from 10 pL/cm 2 to 400 pL/cm 2 , or from 10 pL/cm 2 to 250 pL/cm 2 .
  • Embodiment 72 is the method of any one of embodiments 69 to 71, wherein the metered dose of liquid comprises an aqueous solution, optionally a buffer, optionally comprising a surfactant.
  • Embodiment 73 is the method of any one of embodiments 56 to 72, wherein the assay comprises a lateral flow assay (“LFA”) or vertical flow assay (“VFA”).
  • LFA lateral flow assay
  • VFA vertical flow assay
  • Embodiment 74 is the method of any one of embodiments 56 to 73, wherein the assay is constructed to detect presence of a virus, bacteria, fungus, pathogen, biomarker, biomolecule, metabolite, or other analyte.
  • Embodiment 75 is the method of any one of embodiments 57 to 74, wherein the housing comprises a test result display window.
  • Embodiment 76 is the method of any one of embodiments 56 to 75, wherein the one or more reagents comprise one or more labelling reagents, optionally wherein the one or more reagents comprise antibodies conjugated to gold nanoparticles (e g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), or a combination of two or more thereof.
  • the one or more reagents comprise antibodies conjugated to gold nanoparticles (e g., colloidal gold), latex beads, enzyme conjugates, magnetic particles, fluorescent particles (e.g., quantum dots), or a combination of two or more thereof.
  • Embodiment 77 is the method of any one of embodiments 56 to 76, wherein the observing the indicator of the test result comprises observing the indicator visually.
  • Embodiment 78 is the method of any one of embodiments 56 to 76, wherein the observing the indicator of the test result comprises observing the indicator using an instrument, optionally using a colorimeter.
  • Embodiment 79 is a kit comprising: a sample collection and analysis system comprising: a housing comprising an air inlet constructed to receive an exhalation airflow; a porous sample collection media disposed within the housing, the porous sample collection media comprising a sample receiving region; an airflow path extending from the air inlet through the sample receiving region of the porous sample collection media; an assay constructed to receive an eluted sample from the porous sample collection media; and a liquid flow path extending from the sample receiving region of the porous sample collection media to the assay, the porous sample collection media comprising one or more reagents disposed on the porous sample collection media along the liquid flow path; and instructions for collecting a sample and testing the sample using the assay.
  • a sample collection and analysis system comprising: a housing comprising an air inlet constructed to receive an exhalation airflow; a porous sample collection media disposed within the housing, the porous sample collection media comprising a sample receiving region; an airflow path extending from the air inlet through
  • Embodiment 80 is the kit of embodiment 79, wherein the instructions comprise instructions to: exhale along the airflow path to capture a sample in the porous sample collection media; release a metered dose of liquid onto the porous sample collection media; and observe a test result in a result display of the assay, optionally to read a test result display of the assay using an electronic reader.
  • Embodiment 82 is the sample collection and analysis system of embodiment 81, wherein the blister pack comprises a rupturable material and the blister pack is disposed between the air inlet and the detection zone.
  • Embodiment 83 is the sample collection and analysis system of embodiment 81 or 82, wherein the blister pack is disposed on a nest comprising a plurality of piercing elements extending upward toward a bottom of the blister pack, a center bowl, an opening extending through the center bowl, and a vent.
  • Embodiment 84 the is sample collection and analysis system of embodiment 83, wherein the metered dose of liquid is released through the opening of the center bowl.
  • Embodiment 85 is the sample collection and analysis system of embodiment 81, wherein the blister pack or pouch is arranged to be contacted by a hinged flap to puncture the blister pack and release the metered dose of liquid.
  • Embodiment 86 the is sample collection and analysis system of embodiment 85, wherein the hinged flap is folded over the housing to push against and rupture the blister pack.
  • Embodiment 87 is the sample collection and analysis system of embodiment 81, wherein the blister pack or pouch is arranged to be contacted by a living hinge assembly to rupture the blister pack.
  • Embodiment 88 is the sample collection and analysis system of embodiment 87, wherein the living hinge assembly is aligned with the blister pack and comprises a plurality of living hinges configured to detach from the living hinge assembly and rupture the blister pack.
  • Embodiment 89 is the sample collection and analysis system of embodiment 15, wherein the metered dose of liquid comprises a surfactant.
  • Embodiment 90 is the sample collection and analysis system of 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 if a surfactant.
  • Embodiment 91 is the sample collection and analysis system of embodiment 89 or 90, wherein the surfactant is present in the liquid at a concentration of 0.05 wt-% to 2 wt-%, 0.075 wt-% to 1.5 wt-%, or from 0.1 wt-% to 1 wt-%.
  • Embodiment 92 is the sample collection and analysis system of any one of embodiments 89 to 91, wherein the surfactant comprises a nonionic surfactant.
  • Embodiment 94 is the sample collection and analysis system of 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.
  • Embodiment 95 is the sample collection and analysis system of any one of embodiments 89 to 94, wherein the surfactant comprises a combination of 25 wt-% to 75 wt-% of an alcohol ethoxylate and 25 wt-% to 75 wt-% of a polyethylene glycol sorbitan monolaurate, by total weight of surfactants.
  • the surfactant comprises a combination of 25 wt-% to 75 wt-% of an alcohol ethoxylate and 25 wt-% to 75 wt-% of a polyethylene glycol sorbitan monolaurate, by total weight of surfactants.

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Abstract

L'invention concerne un système de collecte d'échantillons comprenant un boîtier comprenant une entrée d'air conçue pour recevoir un flux d'air d'expiration ; un milieu de collecte d'échantillons poreux disposé à l'intérieur du boîtier, le milieu de collecte d'échantillons poreux comprenant une région de réception d'échantillons ; un trajet de flux d'air s'étendant à partir de l'entrée d'air à travers la région de réception d'échantillons du milieu de collecte d'échantillons poreux ; un dosage construit pour recevoir un échantillon élué à partir du milieu de collecte d'échantillons poreux ; et un trajet de flux de liquide s'étendant de la région de réception d'échantillons du milieu de collecte d'échantillons poreux au dosage. Le milieu de collecte d'échantillons poreux comprend un ou plusieurs réactifs disposés sur le milieu de collecte d'échantillons poreux le long du trajet de flux de liquide.
PCT/US2024/050381 2023-10-09 2024-10-08 Système de collecte et d'analyse d'échantillons Pending WO2025080586A1 (fr)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050124019A1 (en) * 2003-11-04 2005-06-09 Jones Ronald M. Reagent-containing membranes and laminates and methods of their preparation
WO2018183421A1 (fr) * 2017-03-28 2018-10-04 Entvantage Diagnostics, Inc. Dispositifs et procédés de diagnostic de la sinusite
WO2022248992A1 (fr) * 2021-05-28 2022-12-01 3M Innovative Properties Company Dispositif et système de collecte d'échantillon

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050124019A1 (en) * 2003-11-04 2005-06-09 Jones Ronald M. Reagent-containing membranes and laminates and methods of their preparation
WO2018183421A1 (fr) * 2017-03-28 2018-10-04 Entvantage Diagnostics, Inc. Dispositifs et procédés de diagnostic de la sinusite
WO2022248992A1 (fr) * 2021-05-28 2022-12-01 3M Innovative Properties Company Dispositif et système de collecte d'échantillon

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