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WO2025038467A2 - Dispositif de collecte et de test d'échantillon avec éléments intégrés et distincts - Google Patents

Dispositif de collecte et de test d'échantillon avec éléments intégrés et distincts Download PDF

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Publication number
WO2025038467A2
WO2025038467A2 PCT/US2024/041754 US2024041754W WO2025038467A2 WO 2025038467 A2 WO2025038467 A2 WO 2025038467A2 US 2024041754 W US2024041754 W US 2024041754W WO 2025038467 A2 WO2025038467 A2 WO 2025038467A2
Authority
WO
WIPO (PCT)
Prior art keywords
test device
sample
pad
housing
sample collection
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/US2024/041754
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English (en)
Other versions
WO2025038467A3 (fr
Inventor
Andrew Freestone CHARLTON
Jonathan Edward AVILA
Robert Elroy KLEPPER
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.)
ORTHOGONAL DIAGNOSTICS Inc
Original Assignee
ORTHOGONAL DIAGNOSTICS Inc
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 ORTHOGONAL DIAGNOSTICS Inc filed Critical ORTHOGONAL DIAGNOSTICS Inc
Publication of WO2025038467A2 publication Critical patent/WO2025038467A2/fr
Publication of WO2025038467A3 publication Critical patent/WO2025038467A3/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
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • 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
    • 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
    • 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • 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
    • B01L2200/027—Fluid interfacing between devices or objects, e.g. connectors, inlet details for microfluidic devices
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0609—Holders integrated in container to position an object
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • 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

Definitions

  • the technology in part relates to diagnostic test devices and in part relates to test devices that include a lateral flow test strip.
  • the technology in part relates to a test device system that incorporates sample collection, delivering, measuring, processing, incubation, flow regulation and analyzing a sample of interest in a single assembly that includes at least one of the following features: a sample collection unit that is in a non-horizontal orientation relative to a horizontally oriented sample transport pad and test strip, a filter housing unit or cartridge that is discrete and separate from the sample collection unit, and an excess sample reservoir into which excess fluid from the transport pad is drained.
  • Analytical testing of a sample involves multiple steps including collecting, delivering, measuring, processing, incubating and analyzing a sample of interest.
  • Sample collection and processing often requires special and expensive equipment and trained personnel generally available only in laboratories. After a sample is collected, it often is shipped to a laboratory, processed prior to testing, and analyzed.
  • a laboratorian will take a specific volume from the sample, mix it with reagents, incubate the mixture for a predetermined amount of time, and then deliver the resulting processed sample to a test device, analyzer or reaction matrix where the processed sample is analyzed and the results determined, either visually or by an instrument.
  • the sample may need to be split and processed on multiple testing platforms. Accordingly, there is a need for simplification of analytical testing of a sample.
  • a device that includes a sample collection device component and a test device component for processing the sample. Contained in a device provided herein are components for filtration, reagent/chemistry delivery, incubation, flow restriction and sample analysis.
  • a device provided herein generally is self-contained, and provides integrated sample collection, sample metering, multiple sample processing steps, flow restriction and sample testing.
  • a device provided herein is capable of assessing various sample types for the presence or absence and/or amount of one or more targeted markers and/or analytes.
  • a device provided herein generally processes a sample as an integrated unit prior to analysis of the sample and allows for interrogation of results visually or via a reader-based system.
  • a device provided herein includes at least one of the following features: a sample collection unit that is in a non-horizontal orientation relative to a horizontally oriented sample transport pad and test strip, a filter housing unit or cartridge that is discrete and separate from the sample collection unit, and an excess sample reservoir into which excess fluid from the transport pad (used interchangeably herein with transfer pad) is drained.
  • the sample collection unit is in a vertical orientation relative to the horizontally oriented sample transport pad and test strip.
  • the excess sample reservoir permits containment of the sample via, e.g., an absorbent material.
  • a discrete filter housing unit that is separate from the sample collection unit can prevent clogging of the filters by the sample collection pad.
  • a sample collection device that includes: a handle, a stem in connection with the handle, and an absorbent sample pad in connection with the stem, where the sample pad includes a proximal surface, a distal surface and an exterior side surface between the proximal surface and the distal surface; and at least a portion of the sample pad extends from the stem.
  • a sample introduction/collection barrel or unit in a non-horizontal orientation e.g., a vertically oriented barrel
  • the transport pad and the test strip orientation horizontal can permit the device to be more user friendly as it makes it easier to insert the collection handle into the barrel in a downward motion rather than a horizontal motion.
  • the horizontal orientation of the transport pad and test pad is less likely to be disturbed if the barrel for introducing the sample is in a non-horizontal orientation, i.e., at an angle relative to the transport pad and the test pad, such as at a right angle or vertical orientation relative to the transport pad and the test pad, thereby facilitating optimal functioning of the transport pad and test pad by maintaining the position of the transport and test pads on a flat horizonal surface.
  • the handle comprises at least one concave rib to allow for more comfort in the finger when inserting the collection handle into the test device.
  • the collection handle comprises one, two, three, four, five, six, seven, eight, nine, ten or more concave ribs.
  • the collection handle comprises five concave ribs.
  • a rectangular channel 223 inside the shaft (used interchangeably herein with stem) of the collection handle that allows for a saturation indicator to be housed.
  • a snap lock feature 218 that protrudes around the base of the shaft near where it meets the grip handle.
  • a test device that includes a hollow test device housing that includes a proximal terminus, a distal terminus, a sidewall between the proximal terminus and distal terminus, an interior, and a window disposed in the sidewall; a cartridge disposed within the test device housing, the cartridge that includes: a hollow cartridge housing comprising a proximal terminus distally disposed from, and adjacent to, the test device housing proximal terminus, a distal terminus, a sidewall disposed between the proximal terminus and the distal terminus, an interior, and a terminal wall disposed at the distal terminus, and a hollow terminal projection member extending from the terminal wall of the cartridge housing; the terminal projection member including a proximal terminus disposed on the terminal wall, a distal terminus opposite the terminal wall, a sidewall disposed between the proximal terminus and distal terminus, and an interior; a porous transfer pad disposed within the terminal projection member of the
  • the test device includes a flat or horizontal portion where an analyte of interest is tested, and a vertical portion, e.g., a tubular or cylindrical portion, which receives the sample from the sample collection device.
  • the test device includes a filter housing unit or cartridge, proximally disposed from the transfer pad and distal to the test device housing anterior opening rim, in which at least one filter for filtering the sample fluid is housed.
  • the filter housing unit or cartridge is discrete and separated from the sample collection pad so that the sample collection pad is not in direct contact with the filter housing unit.
  • a discrete filter housing unit can prevent or reduce clogging of the filters that can arise from contact with the sample collection pad.
  • the test device includes an excess sample reservoir that collects excess sample fluid from the transport pad, thereby preventing or reducing oversaturation of the transport pad with sample fluid, sample fluid blowing out of the transport pad, or sample fluid flooding onto the test strip.
  • the excess sample reservoir is in a location that is posterior to or behind the transport pad.
  • excess sample fluid from the transport pad is collected in the excess sample reservoir by a passive wicking mechanism.
  • the excess sample reservoir includes an absorbent material for excess sample to be contained.
  • the test device provided herein includes a top housing that contains a flat or horizontal portion and a non-horizontal e.g., vertical) tubular or cylindrical portion.
  • a fillet smoothing contour
  • the sharp edges around the opening of the cylindrical part of the top housing can be smoothed with fillets.
  • composition or kit that includes a sample collection device described herein and a test device described herein, where the sample collection device is separated from the test device.
  • an assembly that includes a sample collection device described herein and a test device described herein, where the sample collection device is joined to the test device.
  • a method for preparing an assembly that includes joining a sample collection device described herein to a test device described herein.
  • a method for determining presence or absence and/or amount of an analyte in a sample which includes detecting a detectable signal from the lateral flow strip through the window of a test device described herein in an assembly with a sample collection device described herein; and determining the presence or absence and/or amount of the analyte in the sample from the detectable signal.
  • a method for manufacturing a sample collection device that includes injecting a liquid polymer into a mold; hardening the polymer in the mold, where the sample collection device or portion thereof is formed in the mold; and separating the sample collection device or portion thereof from the mold. Also provided herein in certain aspects is a method for manufacturing a sample collection device that includes providing a portion of the sample collection device including the handle and stem; and providing the sample pad and joining the sample pad to the stem.
  • a method for manufacturing a test device that includes injecting a liquid polymer into a mold; hardening the polymer in the mold, where the test device anterior member, posterior member or cartridge is formed in the mold; separating the test device anterior member, posterior member or cartridge from the mold. Also provided herein in certain aspects is a method for manufacturing a test device that includes: providing a test device housing posterior member and a test device housing anterior member; contacting the cartridge with the test device housing posterior member and/or the test device housing anterior member; and joining the test device posterior member and the test device anterior member, whereby the cartridge is contained within the test device housing interior.
  • the sample collection barrel of the sample collection device, and the top housing of the test device are combined into a single part which, in aspects, can be made of plastic; in aspects, this combination can result in cost reduction and/or ease of manufacturability.
  • the sample collection device is a separate unit that is not molded to the test device. In certain aspects as described and depicted herein, the sample collection device does not have a top housing.
  • FIG. 1 A is a perspective view of a test device 100 and a separate sample collection device 200.
  • FIG. 1 B is a section view of the test device and sample collection device depicted in FIG. 1 A.
  • FIG. 2 is an enlarged perspective view of sample collection device 200.
  • FIG. 3 is a section view of the sample collection device 200 depicted in FIG. 2.
  • FIG. 4A is a side view of test device 100
  • FIG. 4B is an opposing side view thereof
  • FIG. 40 is a front view thereof
  • FIG. 4D is a rear view thereof
  • FIG. 4E is a top view thereof
  • FIG. 4F is a bottom view thereof.
  • FIG. 5 is a perspective and exploded view of test device 100.
  • FIG. 6 is an enlarged perspective view of the test device housing anterior member 103.
  • FIG. 7 is an enlarged perspective view of the test device housing posterior member 102.
  • FIG. 8 is a side view and exploded view of cartridge 170 and certain pad components.
  • FIG. 9A is an enlarged perspective top view of cartridge 170 without pad components.
  • FIG. 9B is an enlarged perspective bottom view of cartridge 170 with certain pad components.
  • FIG. 10 is a section view of test device 100 through cutting plane B-B shown in FIG. 4D.
  • FIG. 11 is an additional section view of test device 100 through cutting plane B-B shown in FIG. 4D, depicting additional components.
  • FIG. 12 is a perspective view of assembly 300 containing test device 100 and sample collection device 200.
  • FIG. 13A is a side view of test assembly 300
  • FIG. 13B is an opposing side view thereof
  • FIG. 13C is a front view thereof
  • FIG. 13D is a rear view thereof
  • FIG. 13E is a top view thereof
  • FIG. 13F is a bottom view thereof.
  • FIG. 14A is a side view of sample collection device 200 when not joined with test device 100 and FIG. 14B is a side view of sample collection device 200 when joined with test device 100, where test device 100 is shown in broken-line form.
  • FIG. 15 is a perspective view of a test device 100 and a separate sample collection device 200 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 16 is a perspective and exploded view of test device 100 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 17 is an enlarged perspective view of the test device housing anterior member 103 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 18 is an enlarged perspective view of the test device housing posterior member 102 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 19 is an enlarged view of a longitudinal section region of test device 100 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 20 is a section view of assembly 300 as described in U.S. Application No. 17/576,346, which published as U.S. Patent Application Publication No. US2022/0249073, the contents of which are incorporated in their entirety by reference herein.
  • FIG. 21 is a non-limiting example of a set of representative dimensions of the sample collection device 200.
  • FIG. 22 is a non-limiting example of a set of representative dimensions of the test device 100.
  • FIG. 23 is a non-limiting example of an alternate set of representative dimensions of the test device 100.
  • FIG. 24 is a non-limiting example of a set of representative dimensions of the test assembly 300.
  • FIG. 25 is a non-limiting example of an alternate set of representative dimensions of the test assembly 300.
  • Collected samples may require preconditioning, measuring a fixed volume of the sample and incubating the sample prior to testing the sample on a lateral flow device.
  • a device described herein provides the capability to collect a desired sample, filter the sample if required, precondition the sample, extract a measured amount of the sample, mix it with chemical reagents, incubate the mixture for a period of time to ensure proper test reaction or coupling and deliver the sample mixture to a test element where the analysis for the presence or absence and/or amount of one or more analytes (/.e., one or more target molecule) is determined.
  • the completed test element then can be interrogated visually or using a reader system within a matter of minutes.
  • a test element typically is a lateral flow test strip.
  • a device described herein reduces the complexity of the processes so that an individual with minimal training can execute the required steps from sample collection to final result.
  • a device provided herein includes at least one of the following features: a sample collection unit that is in a non-horizontal orientation relative to a horizontally oriented sample transport pad and test strip, a filter housing unit or cartridge that is discrete and separate from the sample collection unit, and an excess sample reservoir into which excess fluid from the transport pad (used interchangeably herein with transfer pad) is drained.
  • the sample collection unit is in a vertical orientation relative to the horizontally oriented sample transport pad and test strip.
  • the excess sample reservoir permits containment of the sample via, e.g., an absorbent material.
  • a discrete filter housing unit that is separate from the sample collection unit can prevent clogging of the filters by the sample collection pad.
  • a sample collection device that includes: a handle, a stem in connection with the handle, and an absorbent sample pad in connection with the stem, where the sample pad includes a proximal surface, a distal surface and an exterior side surface between the proximal surface and the distal surface; and at least a portion of the sample pad extends from the stem.
  • a sample introduction/collection barrel or unit in a non-horizontal orientation e.g., a vertically oriented barrel
  • the transport pad and the test strip orientation horizontal can permit the device to be more user friendly as it makes it easier to insert the collection handle into the barrel in a downward motion rather than a horizontal motion.
  • the horizontal orientation of the transport pad and test pad is less likely to be disturbed if the barrel for introducing the sample is in a non-horizontal orientation, i.e., at an angle relative to the transport pad and the test pad, such as at a right angle or vertical orientation relative to the transport pad and the test pad, thereby facilitating optimal functioning of the transport pad and test pad by maintaining the position of the transport and test pads on a flat horizonal surface.
  • Absorbent materials for use in components of the device provided herein, such as the sample pad, the transport pad and the excess sample reservoir can include polymer fibers, copolymer fibers, sponge or foam materials, cotton fiber materials, blended fibers such as, for example, a blend of polyethylene and polypropylene and combinations thereof including, but not limited to, rayons, polyesters, polyethylene, polypropylene, nylons, polyamides, carbon fibers, alginates, cottons, silks, dacron, rayon, polyurethane and combinations thereof.
  • a test device that includes a hollow test device housing that includes a proximal terminus, a distal terminus, a sidewall between the proximal terminus and distal terminus, an interior, and a window disposed in the sidewall; a cartridge disposed within the test device housing, the cartridge that includes: a hollow cartridge housing comprising a proximal terminus distally disposed from, and adjacent to, the test device housing proximal terminus, a distal terminus, a sidewall disposed between the proximal terminus and the distal terminus, an interior, and a terminal wall disposed at the distal terminus, and a hollow terminal projection member extending from the terminal wall of the cartridge housing; the terminal projection member including a proximal terminus disposed on the terminal wall, a distal terminus opposite the terminal wall, a sidewall disposed between the proximal terminus and distal terminus, and an interior; a porous transfer pad disposed within the terminal projection member of the
  • the test device includes a filter housing unit or cartridge, proximally disposed from the transfer pad and distal to the test device housing anterior opening rim, in which at least one filter for filtering the sample fluid is housed.
  • the filter housing unit or cartridge is discrete and separated from the sample collection pad so that the sample collection pad is not in direct contact with the filter housing unit.
  • a discrete filter housing unit can prevent or reduce clogging of the filters that can arise from contact with the sample collection pad.
  • the test device includes an excess sample reservoir that collects excess sample fluid from the transport pad, thereby preventing or reducing oversaturation of the transport pad with sample fluid, sample fluid blowing out of the transport pad, or sample fluid flooding onto the test strip.
  • the excess sample reservoir is in a location that is posterior to or behind the transport pad. In aspects, excess sample fluid from the transport pad is collected in the excess sample reservoir by a passive wicking mechanism. In certain aspects, the excess sample reservoir includes an absorbent material for excess sample to be contained.
  • a sample collection device component in a non-horizontal orientation relative to the test device components that includes: a handle, a stem in connection with the handle, and an absorbent sample pad in connection with the stem, where: the sample pad includes a proximal surface, a distal surface and an exterior side surface between the proximal surface and the distal surface; and at least a portion of the sample pad extends from the stem distal terminus.
  • a sample pad can be joined to the stem in any suitable manner, including without limitation by an interference fit or a weld (e.g., glue or sonic weld).
  • a stem includes an interior and a portion of a sample pad is disposed within the stem interior.
  • a sample pad is not inserted into a stem and the proximal terminus of the pad is fused to the stem.
  • a handle and stem of a sample collection device can be composed of any suitable material, such as a polymer or polymer blend, for example.
  • a handle and a stem of a sample collection device independently include polypropylene, polyethylene, acrylonitrile butadiene styrene, or a combination of two or more of the foregoing.
  • a handle member can be hollow or not hollow, can be tubular and can be a frustum or a cylinder.
  • a stem member independently can be hollow or not hollow, can be tubular, and can be a frustum or cylinder.
  • a sample collection device can include any suitable sample pad for absorption of sample fluid and delivery of the fluid into a test device.
  • a sample pad of a sample collection device often is compressible.
  • the lateral length of a sample pad sometimes is the major dimension of the sample pad, in which instance the lateral length is greater than the width of the proximal surface and distal surface of the sample pad.
  • the width of the proximal surface and the distal surface of the sample pad is a diameter for instances in which the sample pad is cylindrical.
  • the lateral length of a sample pad sometimes is at least 1 .5-, 2-, 2.5-, 3-, 3.5-, 4-, 4.5-, 5-, 5.5-, 6-, 6.5-, 7-, 8-, 9- or 10- times greater than the width of the proximal surface and/or the distal surface of the sample pad.
  • a sample pad can be laterally compressible (/.e., the lateral length of a sample pad is compressible and can be shortened), as described herein with respect to assemblies of a sample collection device component and a joined test device component.
  • a sample pad has a retention volume (e.g., absorbs a maximum fluid volume) of about 0.1 milliliters to about 10 milliliters, or about 0.25 milliliters to about 2.5 milliliters, or about 1 milliliter to about 2 milliliters; or about 1 .4 milliliters to about 1 .7 milliliters, or about 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95, 1 .0, 1 .1 , 1 .2, 1 .3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1 , 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 28.8, 2.9, 3, 4, 5, 6, 7, 8, 9 or 10 milliliters.
  • a retention volume e.g., absorbs a maximum fluid volume
  • a sample pad has a density of about 0.01 grams/cubic centimeter (g/cc) to about 1 g/cc, or about 0.05 g/cc to about 0.8 g/cc, or about 0.05 g/cc to about 0.6 g/cc, or about 0.3 g/cc to about 0.4 g/cc, or about 0.01 , 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or 1 g/cc.
  • g/cc grams/cubic centimeter
  • a sample pad can include (i) polyethylene, or (ii) polypropylene, or (iii) polyethylene and polypropylene, in certain instances.
  • a sample pad sometimes has a length of about 15 millimeters (mm) to about 55 mm (e.g., about 25 mm to about 45 mm; about 30 mm to about 40 mm; or about 35 mm) and an outer diameter of about 1 mm to about 15 mm (e.g., about 6 mm to about 12 mm; about 8 mm).
  • a sample pad sometimes has an average (e.g., mean, median) pore size (e.g., diameter) of about 5 micrometers to about 60 micrometers, or about 10 micrometers to about 50 micrometers, or about 20 micrometers to about 40 micrometers, or about 30 micrometers to about 35 micrometers (e.g., about 5, 10, 15, 20, 25, 30, 32, 33, 35, 40, 45, 50, 55 or 60 micrometers), sometimes with a minimum pore size (e.g., pore diameter) of about 0.1 micrometers to about 10 micrometers, or about 0.5 micrometers to about 5 micrometers, or about 0.8 micrometers to about 2 micrometers (e.g., 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.2, 1.4, 1.6, 1.8, 2.0, 2.2, 2.4, 2.6, 2.8, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0,
  • a sample pad of a sample collection device, and optionally pad(s) of a test device sometimes each is unitary and does not include a bore.
  • a sample pad sometimes is a single pad, and sometimes does not include multiple pads.
  • a sample pad is an assembly of multiple pads.
  • a sample pad of a sample collection device sometimes includes one or more reagents.
  • the one or more reagents are chosen from a buffering agent, detergent, protein, enzyme, antibody or antigen-binding fragment thereof, antigen, binding pair member, bulking agent, water-absorbing agent, saccharide, polysaccharide, nucleic acid amplification reagent, nucleic acid and aptamer.
  • the one or more reagents sometimes are distributed on and/or in all or a portion of a sample pad.
  • a property of the sample pad changes upon contact with a fluid (e.g., a sample fluid), which change indicates to an operator that a sufficient amount of sample fluid has been absorbed by the sample pad.
  • a sample pad can contain a colorimetric agent that shifts color upon contact with fluid in certain instances.
  • a colorimetric agent can be disposed at a zone of the sample pad, which sometimes is referred to herein as an observation zone.
  • a zone can be a transverse band circumferentially disposed in or on the sample pad in certain instances.
  • a zone sometimes is disposed at the distal terminus or in a distal portion of a sample pad, and/or sometimes is disposed at the proximal terminus or proximal region of the sample pad.
  • a colorimetric agent changes color upon contact with fluid in a sample pad.
  • a colorimetric agent can change from one color to higher intensity color or lower intensity color or no color, can change from one color to a different color, or can change from no detectable color to a detectable color, in certain instances.
  • a sample collection device sample pad can include any suitable colorimetric agent, and in certain implementations a colorimetric agent is a dye (e.g., a triarylmethane dye (e.g., Brilliant blue FCF)) and/or a pH indicator.
  • a colorimetric agent sometimes is dehydrated on and/or in a sample pad and becomes hydrated upon sample pad uptake of a fluid.
  • a sample pad includes a structural material (e.g., a fiber) that changes color upon contact with a fluid (e.g., changes from colored to lower intensity color or colorless upon contact with a fluid).
  • a sample pad or portion thereof swells when contacted with a fluid.
  • a handle and/or stem or portion thereof contains an observation zone.
  • a handle and/or stem, or portion thereof sometimes is transparent or translucent or open (i.e., cutout section).
  • a transparent or translucent or open section of the stem and/or handle can function as an observation zone or window that permits viewing of a colorimetric agent or physical change by an operator. An operator can visually observe a colorimetric change by eye in an observation zone, or observe a physical change visually or by touch in an observation zone, for example.
  • An observation zone can include one or more user-viewable indicator marks that can facilitate determination by an operator that a sufficient amount of sample fluid has been absorbed by the sample pad (e.g., a physical change or colorimetric change at a particular indicator mark can provide an indication to an operator that a sufficient amount of sample fluid has been absorbed by the sample pad).
  • an observation zone is located in a stem member (e.g., described herein).
  • a dehydrated colorimetric agent in a distal region of a sample pad hydrates, e.g., behind the stem wall, upon sample pad absorption of a fluid, and flows to an observation zone.
  • a hydrated colorimetric agent can be visualized as a colored smear in an observation zone.
  • a portion of a sample pad is not present in an observation zone and swells into the observation zone, notifying an operator that the sample pad has absorbed a sufficient amount of fluid.
  • a portion of the handle can deform when a sample pad swells, notifying an operator that the sample pad has absorbed a sufficient amount of fluid.
  • a sealing member is disposed on or in a handle and/or a stem of a sample collection device.
  • a sample collection device includes a first sealing member and a second sealing member each disposed on the stem.
  • Any suitable sealing member can be incorporated on or in a sample collection device, including without limitation one or more o-rings constructed from a deformable material ⁇ e.g., an elastomer).
  • a sample collection device can include a connector member configured to engage with a connector member counterpart disposed on or in a test device.
  • a connector member is a lock member in certain implementations.
  • a connector member can be disposed on or in any suitable location of the sample collection device for connecting engagement with a connector member counterpart disposed on or in a test device described herein.
  • a connector member and/or lock member can be reversible or irreversible under a tool-less pulling force generated by a human of average strength.
  • a lock member sometimes is disposed on or in the stem and sometimes is disposed on or in the handle of the sample collection device. In certain instances, a lock member is disposed on the stem between the handle and the sealing member.
  • a lock member can be incorporated on or in a sample collection device, non-limiting examples of which include an interference-fit member ⁇ e.g., projection/receptacle ⁇ e.g., annular projection/annular groove)) or a threaded member ⁇ e.g., threaded grooves/threaded projections).
  • a handle of a sample collection device includes an interior surface spaced from an exterior surface of the stem, and the interior surface spaced from the exterior surface of the stem includes a threaded lock member.
  • a stem of a sample collection device includes an annular projection disposed between the stem proximal terminus and a sealing member ⁇ e.g., o-ring).
  • a handle of a sample collection device is a tubular handle or includes a tubular portion, that includes a handle proximal terminus, a handle distal terminus and a handle wall between the handle proximal terminus and the handle distal terminus; and/or (ii) a stem is a tubular stem or includes a tubular portion, that includes a stem proximal terminus, a stem distal terminus, a stem wall between the stem proximal terminus and the stem distal terminus and a tubular stem interior; where the stem proximal terminus is in connection with the handle distal terminus.
  • the sample pad can be a cylindrical pad or include a cylindrical portion.
  • a first portion of the sample pad side is inserted within the tubular stem interior (/.e., a proximal portion of the sample pad), and a second portion of the sample pad side extends from the stem distal terminus (/'.e., a distal portion of the sample pad).
  • the sample pad of a sample collection device can include sample fluid.
  • the sample fluid generally is absorbed in the sample pad and can be any suitable fluid for analysis in a device described herein.
  • a sample fluid sometimes is a biological sample fluid that contains molecules from a biological entity.
  • a sample fluid can be from any suitable biological entity, non-limiting examples of which include a unicellular organism, multi-cellular organism, a cell from a multi-cellular organism, eukaryotic cell, prokaryotic cell, microorganism, bacterium, archaeon, fungus, plant, virus, organelle (e.g., mitochondria or chloroplast), liposomal vector and extracellular vesicle.
  • a sample fluid sometimes is from a human subject or non-human subject.
  • a non-human subject sometimes is a mammal, reptile, avian, amphibian, fish, ungulate, ruminant, bovine (e.g., cattle), equine (e.g., horse), caprine and ovine (e.g., sheep, goat), swine (e.g., pig), camelid (e.g., camel, llama, alpaca), monkey, ape (e.g., gorilla, chimpanzee), ursid (e.g., bear), poultry, dog, cat, mouse, rat, fish, dolphin, whale and shark.
  • a subject may be a male or female (e.g., woman, a pregnant woman).
  • a subject may be any age (e.g., an embryo, a fetus, infant, child, adult).
  • a biological fluid from a human or non-human subject include saliva, urine, blood (e.g., whole blood, blood fraction), semen and vaginal fluid, and can be derived from a biological sample (e.g., fecal matter, ear wax, biopsy sample).
  • a sample fluid sometimes includes molecules from an environmental source, non-limiting examples of which include a water sample, soil sample, or other environmental sample that may contain a toxic substance (e.g., biohazard substance).
  • a sample fluid absorbed into a sample pad can be an unprocessed sample fluid directly from a source (e.g., a subject) that optionally has been stored, or can be a fluid that has been processed and optionally stored (e.g., diluted, concentrated, treated with one or more reagents (e.g., a preservative)).
  • a sample fluid can be absorbed into a sample pad in any suitable manner, including for example, directly contacting the sample pad with a sample fluid source.
  • a sample pad may be placed on or in the body of a subject (e.g., a sample pad may be placed in the mouth of a subject for absorption of a saliva sample).
  • a sample can be collected in a container and then a sample pad can be contacted with a collected sample fluid, or a fluid containing a collected sample, for absorption into the sample pad (e.g., collecting saliva in a container and then absorbing the collected saliva into a sample pad).
  • a sample pad can be contacted with a collected sample fluid, or a fluid containing a collected sample, for absorption into the sample pad (e.g., collecting saliva in a container and then absorbing the collected saliva into a sample pad).
  • a sample collection device can be joined with a test device after absorbing a sample fluid in the sample pad without processing or storing the sample fluid.
  • a sample collection device can be joined with a test device after the sample collection device has been stored (e.g., in a sealed container, e.g., in a sealed bag) and/or optionally processed, or after the sample has been collected in a container and/or optionally processed.
  • sample collection device 200 illustrated in FIG. 1 A to FIG. 3, which also is referred to herein as a "sample collector.” As shown in FIG. 1 A, sample collection device 200 is configured for insertion into test device 100 and is configured for sealing attachment and locked attachment to test device 100.
  • Sample collection device 200 includes a cylindrical handle 201 having a handle proximal terminus 202, a handle distal terminus 204, and a handle sidewall 203 between the proximal terminus 202 and the distal terminus 204.
  • Sample collection device handle 201 includes a hollow portion, and sidewall 203 includes an exterior surface (as shown in FIG. 2) and an interior surface 205 (as shown in FIG. 3).
  • Handle member 201 of sample collection device 200 includes an interior step 206 disposed at the distal terminus of the interior of the handle, which transitions from the handle portion to the stem portion, the latter of which is described hereafter.
  • the handle proximal terminus 202 comprises at least one concave rib to allow for more comfort in the finger when inserting the collection handle into the test device.
  • the collection handle comprises one, two, three, four, five, six, seven, eight, nine, ten or more concave ribs.
  • the collection handle comprises five concave ribs.
  • Sample collection device 200 includes a tubular stem portion 210, having a proximal terminus 212, distal terminus 213, and sidewall 214, as shown in FIG. 2.
  • Stem member 210 is a frustum, with sidewall 214 tapering from proximal terminus 212 to distal terminus 213, where the internal diameter at proximal terminus 212 is greater than the internal diameter at distal terminus 213.
  • Stem member 210 of sample collection device 200 is hollow and stem sidewall 214 includes an exterior surface (as shown in FIG. 2), and an interior surface (e.g., interior surface 216 and 224 shown in FIG. 3).
  • the sample collection device 200 has a vertical orientation relative to the transport pad and test strip of the test device 100 as shown in FIGS. 1 A and 1 B.
  • Stem member 210 includes two o-ring sealing members 215 and 217 each disposed within an annular groove receptacle located on the exterior surface of stem sidewall 214, opposite the second stem interior compartment.
  • a single o-ring sealing member or one or more other types of sealing members can replace o-ring sealing members 215 and 217 of stem member 210 in certain implementations.
  • a stem member sometimes includes no sealing members in certain instances.
  • Stem member 210 also includes stem annular protrusion 218.
  • Annular protrusion 218 is a connection member configured to engage with and connect to a connector member counterpart in test device 100.
  • Connector member annular protrusion 218 is a lock member and also is referred to herein as a click lock feature.
  • Sample collection device 200 also includes cylindrical sample pad 230, which also is referred to as an absorbent collection pad, which includes pad side surface 232, pad distal terminus (distal surface) 234, and pad proximal terminus (proximal surface) 235, as depicted in FIG. 2 and FIG. 3.
  • Sample pad 230 has a lateral length 290a (see FIG. 14A), which is the major dimension of the sample pad and is perpendicular to lateral axis 198 (see FIG. 10), when the sample collection device 200 is in the vertical orientation relative to the horizontal orientation of test device 100 as depicted in FIGS. 1 A and 1 B.
  • a proximally disposed portion of sample pad 230 is disposed within the second stem interior compartment.
  • sample pad side surface 232 of the proximally disposed portion contacts interior stem sidewall surface 224 within the second stem interior compartment.
  • a distally disposed portion of sample pad 230 extends from stem member 210, past stem distal terminus 213.
  • the portion of sample pad side 232 in this distally disposed portion can contact a fluid sample for absorption of sample fluid into sample pad 230 and can be disposed within cartridge housing lumen 173d and 173e when sample collection device 200 is joined to test device 100 (e.g., sealingly joined and/or in locked engagement).
  • Distal surface 234 of sample pad 230 also can contact a fluid sample for absorption of sample fluid into sample pad 230, and when sample collection device 200 is joined to test device 100, the sample fluid can be transported to the filter housing unit (e.g., proximal surface 145a of cartridge housing pad 145) when such a pad is disposed in the interior of cartridge housing 170.
  • the filter housing unit e.g., proximal surface 145a of cartridge housing pad 1405
  • cylindrical handle member 201 , tubular stem member 210 and cylindrical sample pad 230 are concentrically disposed. Stated another way, (i) the midpoint between the sidewall exterior surfaces at proximal terminus 202 of handle 201 , (ii) the midpoint between the sidewall exterior surfaces at proximal terminus 212 of stem 210, and (iii) the midpoint between the sidewall exterior surfaces at proximal surface 235 of sample pad 230, are concentric.
  • An observation zone as described herein can be located in stem portion 210, sometimes between sealing rings 215 and 217.
  • a test device component that includes: a hollow test device housing that includes a proximal terminus, a distal terminus, a sidewall between the proximal terminus and distal terminus, an interior, and a window disposed in the sidewall; a cartridge disposed within the test device housing, the cartridge including: a hollow cartridge housing that includes a proximal terminus distally disposed from, and adjacent to, the test device housing proximal terminus, a distal terminus, a sidewall disposed between the proximal terminus and the distal terminus, an interior, and a terminal wall disposed at the distal terminus, and a hollow terminal projection member extending from the terminal wall of the cartridge housing, the terminal projection member including a proximal terminus disposed on the terminal wall, a distal terminus opposite the terminal wall, a sidewall disposed between the proximal terminus and distal terminus, and an interior; a porous transfer pad disposed within the terminal projection member of
  • a sidewall of a test device housing, cartridge housing and cartridge terminal projection each independently is one continuous sidewall (/.e., in the case of a cylindrical or frustum portion of the test device) and sometimes is two, three, four or more sidewalls (e.g., in the case of a rectilinear portion of the test device).
  • the test device housing, cartridge housing and cartridge terminal projection can be of any suitable configuration for (i) receiving a sample pad or portion thereof from a sample collection device through a proximal opening of the test device, or (ii) receiving in the interior of the cartridge housing lumen the sample pad or portion thereof, or (iii) laterally compressing the sample pad with the distal surface of the transfer pad contacting the terminal wall of the cartridge housing or a cartridge housing pad directly contacting the terminal wall or in a series of cartridge housing pads in which one cartridge housing pad contacts the terminal wall, or (iv) transmitting sample fluid expressed by the sample pad through the terminal wall to the transfer pad and to the lateral flow strip, or (v) a combination of two, three or all of (i), (ii), (iii) and (iv).
  • the test device housing is a tube
  • the cartridge housing is a tube
  • the cartridge terminal projection is a tube, or (iv) a combination of two or more of (i), (ii) and (iii).
  • the interior surface of the sidewall of each of the test device housing, cartridge housing, and cartridge terminal projection defines an interior lumen.
  • the midpoint between sidewall interior surfaces at the proximal terminus of the cartridge housing, (ii) the midpoint between the sidewall interior surfaces at the proximal terminus of the test device housing, and/or (iii) the midpoint between the sidewall interior surface at the proximal terminus of the cartridge terminal extension, are concentric.
  • the test device housing and the cartridge sometimes independently include polypropylene, polyethylene, acrylonitrile butadiene styrene, or a combination of two or more of the foregoing.
  • the test device housing is a two-piece housing comprising an anterior member and a posterior member, and sometimes the posterior member includes at least one connector, and the anterior member includes at least one connector counterpart.
  • the cartridge is a unitary member.
  • a cartridge and a test device housing can be separate entities (e.g., separate molded entities) that are assembled into a test device component or can be incorporated together in a unitary test device component e.g., the cartridge and test device housing are molded as part of one molded component).
  • a cartridge contains a posterior member and an anterior member, the anterior member of the cartridge is co-molded with an anterior test device housing member and the posterior member of the cartridge is co-molded with a posterior test device housing member.
  • the test device housing includes a first region.
  • the first region of the test device housing sometimes is a tube that includes a circular or ovoid cross section, and sometimes the first region of the test device housing is a cylindrical tube.
  • the first region of the test device housing often is co-terminal with the proximal terminus of the test device housing.
  • the test device housing includes a second region.
  • a second region of the test device housing sometimes is a tube that includes a lateral planar cylindrical segment region, where the second region often is co-terminal with the distal terminus of the test device housing.
  • a test device housing includes a third region.
  • the third region of the test device housing sometimes is a tube that includes a lateral arcoid cylindrical segment region.
  • Curvature of the lateral arcoid cylindrical region generally is defined by an edge (e.g., a linear edge) of a virtual plane rotated around a transversely aligned axis spaced from the anterior surface of the test device housing, where the transversely aligned axis is parallel to the transverse axis 194 illustrated in FIG. 4D.
  • a third region often is disposed between the first region and the second region of the test device housing and is co-extensive with the first region and the second region of the test device housing.
  • the test device housing includes a bore, and the perimeter of the bore defines the window.
  • a window often is an opening defined by a bore in a test device housing, at which the test strip within the housing is exposed. Sometimes a window includes a transparent or translucent lens through which an optical signal from the lateral flow strip can transmit.
  • the perimeter of the bore sometimes is ovoid or polygonal or a combination thereof.
  • the perimeter of the bore sometimes is a combination of ovoid boundaries (e.g., ovoid proximal and distal boundaries) and linear laterally disposed boundaries.
  • the window is disposed in a portion of the second region and an adjoining portion of the third region of the test device housing.
  • a cartridge housing can be of any suitable geometry that (i) contains a sample pad or portion thereof of a sample collection device component that can be joined with a test device, or (ii) orients the terminal wall of the cartridge housing in a position that facilitates compression of the sample pad, with or without a cartridge housing pad disposed between the terminal wall and the sample pad distal terminus, or (iii) a combination of (i) and (ii).
  • the cartridge housing is a tube that includes a circular or ovoid cross section.
  • the sidewall of the cartridge housing or portion thereof sometimes tapers from the proximal terminus towards the distal terminus, where the interior diameter at the proximal terminus is greater than the interior diameter of a portion distally spaced from the proximal terminus.
  • the cartridge housing includes a frustum portion, and sometimes includes two frustum portions, with a proximally disposed first frustum portion defined by sidewalls having one exterior draft angle, and another distally disposed second frustum portion contiguous with the first frustum portion and defined by sidewalls having a second exterior draft angle, where the second draft angle is greater than the first draft angle.
  • the cartridge terminal projection is a tube configured to retain a transfer pad or portion thereof.
  • a cartridge terminal projection sometimes includes a polygon cross section, polygon distal terminus and/or polygon proximal terminus.
  • the polygon can be a quadrilateral, rectangle or square in certain instances.
  • a transfer pad can be disposed in a cartridge terminal projection member in any suitable manner that permits transmission of fluid from the sample pad to the lateral flow strip.
  • a proximal portion of the transfer pad is disposed within the cartridge terminal projection member and a distal portion of the transfer pad extends from the distal terminus of the cartridge terminal projection member.
  • the cartridge housing sidewall includes an interior surface
  • the cartridge housing terminal wall includes an interior surface having a perimeter coextensive with the cartridge sidewall interior surface.
  • a transfer pad includes an anterior surface and an opposite posterior surface each between the proximal surface and the distal surface of the pad, and the anterior side surface and the posterior side surface of the transfer pad each contact an interior surface of the cartridge terminal projection member.
  • a transfer pad can be joined to a cartridge terminal projection member in any suitable manner, and sometimes a transfer pad is disposed within the cartridge terminal projection member by an interference fit or sometimes is adhered to a terminal projection member by a weld (e.g., adhesive or sonic weld).
  • a weld e.g., adhesive or sonic weld
  • the cartridge terminal wall includes one or more bores.
  • a cartridge terminal projection member often includes an interior and often the one or more bores in the cartridge terminal wall each include a distally disposed aperture within the interior of the terminal projection member.
  • a transfer pad includes a proximal surface and a distal surface, and the proximal surface of the transfer pad contacts an exterior surface of the cartridge terminal wall and the one or more bores in the terminal wall.
  • the surface area of a bore (where there is one bore) or combined surface area of bores (where there are multiple bores) sometimes is about 1 square millimeter to about 50 square millimeters, or about 5 square millimeters to about 20 square millimeters, or about 10 square millimeters to about 15 square millimeters, or about 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45 or 50 square millimeters.
  • the surface area of the interior surface of the terminal wall of the cartridge housing, inclusive of the surface area of one or more bores in the terminal wall sometimes is about 20 square millimeters to about 100 square millimeters, or about 40 square millimeters to about 80 square millimeters, or about 50 square millimeters to about 70 square millimeters, or about 20, 25, 30, 35, 40, 45, 50, 55, 56, 57, 58, 59, 60, 61 , 62, 63, 64, 65, 66, 67, 68, 69, 70, 71 , 72, 73, 74, 75, 80, 85, 90, 95 or 100 square millimeters.
  • a ratio of (i) the surface area of the bore or combined surface area of multiple bores, to (ii) the surface area of the interior surface of the terminal wall of the cartridge housing (inclusive of the surface area of one or more bores in the terminal wall), is about 0.05 to about 2, or about 0.08 to about 0.5, or about 0.1 to about 0.3, or about 0.15 to about 0.30, or about 0.20 to about 0.25, or about 0.05, 0.07, 0.09, 0.10, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21 , 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31 , 0.32, 0.33, 0.34, 0.35, 0.40, 0.45 or 0.50.
  • a transfer pad can be disposed relative to a lateral flow strip in any suitable orientation for transmission of sample fluid from the transfer pad to the lateral flow test strip.
  • a portion of the posterior side surface of the transfer pad contacts a portion of the anterior surface of the lateral flow strip.
  • a portion of the distal surface of the transfer pad contacts a portion of the proximal surface of the strip.
  • the lateral flow strip includes a lateral length and a perpendicular transverse width
  • the transfer pad includes a lateral length and a perpendicular transverse width
  • the transfer pad width is substantially the same or the same as the lateral flow strip width.
  • a transverse width is parallel to transverse axis 194 illustrated in FIG. 4D and a lateral length is parallel to lateral axis 198 illustrated in FIG. 10.
  • a lateral flow strip can be contained in a test device in any suitable manner that permits fluid transmission from the transfer pad to the lateral flow strip and observation of an anterior portion of the strip through a window in the test device housing.
  • a lateral flow strip is retained in the test device housing by one or more strip retaining members disposed on an interior surface of the test device housing sidewall.
  • each of the one or more strip-retaining members extends from a posterior sidewall interior surface of the test device housing sidewall.
  • the one or more strip retaining members sometimes include (i) one or more laterally disposed ribs, or (ii) one or more containment posts, or (iii) a combination of (i) and (ii).
  • the lateral length of a laterally disposed rib generally is the major dimension of such a rib, and the lateral length is parallel to lateral axis 198 illustrated in FIG. 10.
  • the posterior surface of the strip or portion thereof sometimes contacts an anterior edge of each of the one or more laterally disposed ribs of the test device housing.
  • a lateral flow strip generally includes a laterally disposed edge on each side of the posterior surface of the strip, and for instances in which a test device includes one or more containment posts, each laterally disposed edge of the strip sometimes contacts a portion of one or more containment posts disposed in the test device housing.
  • a longitudinal length often is the major dimension of a containment post, where the longitudinal length is parallel to longitudinal axis 199 illustrated in FIG. 10.
  • a containment post can include any suitable minor dimension profile for retaining a lateral flow strip at a contact point with the edge of the strip, and sometimes a containment post minor dimension profile is a polygon (e.g., triangle or quadrilateral (e.g., square, rectangle, rhombus)) or is ovoid (e.g., oval or circle).
  • a test device can include one or more members that facilitate fluid transfer from a transfer pad to a lateral flow strip.
  • the test device housing includes an anterior sidewall interior surface and an extension bar extending from the anterior sidewall interior surface.
  • An extension bar sometimes includes a posterior surface (/.e., the term posterior surface is used interchangeably with the term posterior edge for an extension bar). The posterior edge of the extension bar, or portion of the posterior edge, often contacts a portion of the anterior surface of the transfer pad, and sometimes contacts a portion of the anterior surface of the transfer pad opposite the anterior surface of the lateral flow strip.
  • an anterior sidewall interior surface refers to an interior surface disposed in an anterior portion of the test device housing sidewall
  • a posterior sidewall interior surface refers to an interior surface disposed in a posterior portion of the test device housing sidewall (see, e.g., longitudinal axis 199 disposed in the posterior to anterior direction).
  • an extension bar can apply downward pressure (i.e., in the anterior to posterior direction) to the transfer pad and to the test strip, which can partially restrict or reduce fluid flow from the transfer pad to the test strip compared to implementations in which an extension bar does not apply pressure to the transfer pad. Reduction of fluid flow by a transfer pad can reduce potential for flooding of the test strip as sample fluid is transmitted from the transfer pad, and pressure exerted by the extension bar can assure contact of the transfer pad uniformly along the interface of the transfer pad and the test strip.
  • a test device can include an excess sample reservoir 153 (see, e.g., FIG. 1 B and FIG. 14B).
  • a test device can include one or more members that retain the cartridge within the test device housing interior and/or facilitate fluid transmission from the sample pad to the lateral flow strip, such as extension walls (see, e.g., FIG. 17 and FIG. 18) that depict certain implementations of the device described in U.S. Patent Application No. 17/576,346, which published as U.S. Application Publication No. US20220249073, the contents of which are incorporated in their entirety by reference herein.
  • a test device includes (i) a first extension wall disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall, and/or (ii) a second extension wall disposed on and extending from an anteriorly disposed interior surface of the test device housing sidewall.
  • the first extension wall can include an anterior edge and the second extension wall can include a posterior edge, where the anterior edge of the first extension wall sometimes opposes and sometimes is spaced from the posterior edge of the second extension wall.
  • the cartridge terminal projection includes an anterior wall and a posterior wall, the anterior edge of the first extension wall contacts an exterior surface of the terminal projection posterior wall, and the posterior edge of the second extension wall contacts an exterior surface of the terminal projection anterior wall.
  • a test device includes a third extension wall and a fourth extension wall each disposed on and extending from a posteriorly disposed sidewall interior surface of the test device housing sidewall.
  • the third extension wall sometimes includes an interior side (i.e., a face of the extension wall opposed to the center of the test device housing) that opposes an interior side of the fourth lateral extension wall.
  • the transverse length of the first extension wall is the major dimension of the first extension wall (i.e., the major dimension is parallel to transverse axis 194 shown in FIG. 4D)
  • the third extension wall and the fourth extension wall each include a lateral length that is the major dimension of each wall (i.e., the major dimension is parallel to lateral axis 198)
  • the first extension wall is perpendicularly disposed to each of the third extension wall and the fourth extension wall.
  • the first extension wall sometimes has a major dimension (i.e., length) aligned parallel to transverse axis 194 (shown in FIG. 4D)) and perpendicular to lateral axis 198 (shown in FIG. 10), and the third and fourth extension walls sometimes each have a major dimension (i.e., length) aligned parallel to lateral axis 198 and perpendicular to the transverse axis 194.
  • Extension structures in the test device housing e.g., extension wall, extension bar
  • the first extension wall, second extension wall, third extension wall, fourth extension wall, extension bar, integrated posts and interior window projection(s) can collectively serve as a reservoir that can contain any residual sample fluid, and the residual sample fluid can be reabsorbed into the transfer pad if any initially exits the transfer pad.
  • the residual sample fluid can be reabsorbed into the transfer pad by changing the orientation of the test device (e.g., an operator may rotate or shake the device or stand the device in an orientation in which the device does not rest on a base extension).
  • the containment structure created by the extension structures can, in aspects, be present in addition to excess sample reservoir 153 or, in certain aspects, be present instead of excess sample reservoir 153.
  • a cartridge terminal projection includes a sidewall and an opposing sidewall between the anterior wall and the posterior wall, a portion of the internal side of the third extension wall contacts an exterior surface of the cartridge terminal projection sidewall, and a portion of the internal side of the fourth extension wall, contacts an exterior surface of the cartridge terminal projection opposing sidewall in a test device.
  • each of the first, second, third and fourth extension walls in part can retain the cartridge terminal projection, and thereby in part retain the cartridge, in the test device housing.
  • the first and second extension walls can restrain longitudinal movement of the cartridge, and the third and fourth extension walls can restrain transverse movement of the cartridge, within the test device housing.
  • test device can include additional members that retain the cartridge within the test device housing interior.
  • the test device housing includes a proximal opening rim and an annular recessed surface distally disposed and adjacent to the proximal opening rim, where the proximal terminus of the cartridge housing contacts the annular recessed surface of the test device housing.
  • the test device housing includes an annular projection disposed on an interior surface of the test device housing sidewall and distally disposed from the proximal opening rim, where the annular projection contacts a portion of an exterior surface of the cartridge housing sidewall.
  • the cartridge housing includes an annular collar extending from an exterior surface of the cartridge housing sidewall
  • the test device housing includes a proximal opening rim and an annular recessed surface distally disposed and adjacent to the proximal opening rim, and the collar contacts the annular recessed surface of the rim of the test device housing.
  • the test device housing includes an annular projection disposed on an interior surface of the test device housing sidewall and distally disposed from the proximal opening rim, and a surface of the collar contacts the annular projection.
  • surfaces of the collar contact the annular recessed surface of the rim, a proximally disposed surface of the annular projection, and a portion of the interior surface of the test device housing sidewall disposed between the annular recessed surface and the annular projection.
  • a test device can include further members that retain the cartridge within the test device housing interior and/or facilitate fluid transmission from the sample pad to the lateral flow strip.
  • a test device can include post members each disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall. A portion of one post member can contact a portion of the distal terminus of the terminal projection of the cartridge. A portion of another post member can contact another portion of the distal terminus of the terminal projection of the cartridge.
  • the third extension wall and the fourth extension wall of the test device housing each include a distal side, where one post member is integrated with the distal side of the third extension wall, and another post member is integrated with the distal side of the fourth extension wall.
  • the third extension wall and the fourth extension wall each include a proximal side, where the proximal side of the third extension wall contacts an exterior portion of the terminal wall of the cartridge housing, and the proximal side of the fourth extension wall contacts another exterior portion of the terminal wall of the cartridge housing.
  • the post members or (ii) the annular recessed surface adjacent to the proximal opening rim, or (iii) proximal side of the third extension wall and the fourth extension wall, or (iv) combination of two or more of (i), (ii) and (iii), in part can retain the cartridge in the test device housing by restraining lateral movement of the cartridge.
  • a test device can include a connector member configured to connect to a connector member counterpart disposed on or in a sample collection device component.
  • a connector member sometimes is a lock member that locks the test device to a sample collection device component. Any suitable type of connector member can be present on or in a test device and in any suitable location.
  • a connector member sometimes is a groove or protrusion (e.g., an annular groove or annular protrusion), which can engage with a counterpart member by an interference fit, and sometimes is a threaded connector (e.g., a threaded groove or a threaded projection).
  • a connector member/lock member can be disposed on an interior surface of the test device housing or the cartridge housing, or on an exterior surface of the test device housing (e.g., on or in the proximal edge of the housing) or the cartridge housing.
  • the cartridge housing includes an annular recessed edge adjacent to the proximal terminus
  • the test device housing includes a proximal opening rim and an annular recessed surface adjacent to the proximal opening rim
  • the annular groove is disposed between the annular recessed edge of the cartridge housing and the annular recessed surface of the test device housing.
  • the cartridge housing includes a hollow shank extending from the cartridge housing proximal terminus and the lock member counterpart is a threaded member disposed on the shank.
  • the shank sometimes is cylindrical and sometimes includes a wall portion having an exterior surface and interior surface. Threads can be disposed on the shank exterior surface or on the shank interior surface and can be threaded grooves or threaded projections.
  • a test device can include a sealing member configured for sealing connection of the sample collection device component to the test device component.
  • a sealing member counterpart can be disposed on an interior surface of the test device housing and/or an interior surface of the cartridge housing.
  • a sealing member counterpart in the test device is optional, and a test device component can seal to a sample collection component without a sealing member counterpart in the test device, in certain implementations.
  • a sealing member sometimes is not present within the test device (e.g., not present on or in an interior wall portion of the test device housing or the cartridge housing).
  • a test device component can include one more porous cartridge pads disposed in an interior portion of the cartridge housing, in certain implementations.
  • each of the one or more porous cartridge pads includes a proximal surface, a distal surface and a side surface disposed between the proximal surface and the distal surface.
  • the terminal wall of the cartridge housing typically includes an interior surface, and the distal surface of a cartridge pad can contact the interior surface of the cartridge housing terminal wall.
  • a test device sometimes includes two or more porous cartridge pads disposed in a stacked assembly.
  • a first pad often is proximally disposed relative to an adjacent second pad
  • the first pad and the second pad each generally include a proximal surface, a distal surface and a side surface disposed between the proximal surface and the distal surface, and the distal surface of the first pad often contacts the proximal surface of the second pad.
  • the transfer pad is in fluid communication with the one or more porous cartridge pads, and sometimes the proximal surface of the transfer pad is in fluid communication, via the bores in the terminal wall of the cartridge housing, with the distal surface of a cartridge housing pad.
  • the cartridge housing sidewall includes an interior surface, and the side surface of each of the one or more cartridge pads contacts a portion of the interior surface of the cartridge housing sidewall.
  • a test device sometimes includes no cartridge pad disposed in an interior portion of the cartridge housing.
  • the transfer pad of a test device component includes (i) polyethylene, or (ii) polypropylene, or (iii) polyethylene and polypropylene.
  • a retention volume (e.g., absorbs a maximum fluid volume) of a transfer pad is of about 20 microliters to about 1 milliliter, or about 50 microliters to about 500 microliters, or about 100 microliters to about 300 microliters, or about 100, 1 10, 120, 130, 140, 150, 160, 170, 180, 190, 195, 200, 205, 210, 215, 220, 230, 240, 250, 260, 270, 280, 290 or 300 microliters.
  • a lateral length of a transfer pad sometimes is the major dimension of the transfer pad (/.e., the lateral length is parallel to lateral axis 198 shown in FIG. 10), and the lateral length of the transfer pad often is greater than the transverse width of the transfer pad at the transfer pad distal terminus and proximal terminus.
  • a transfer pad sometimes has a lateral length of about 8 millimeters (mm) to about 16 mm (e.g., about 10, 11 , 12, 13, 14 or 15 mm); a transverse width of about 4 mm to about 10 mm (e.g., about 5, 6, 7, 8, 9 or 10 mm); and a longitudinal height of about 1 mm to about 5 mm (e.g., about 1 , 2, 3, 4 or 5 mm).
  • a transfer pad sometimes has an average (e.g., mean, median) pore size (e.g., pore diameter) of about 2 micrometers to about 100 micrometers, or about 10 micrometers to about 40 micrometers, or about 20 micrometers to about 30 micrometers, or about 23 micrometers to about 28 micrometers (e.g., about 2, 3, 4, 5, 10, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100 micrometers), sometimes with a minimum pore size (e.g., pore diameter) of about 0.1 micrometers to about 10 micrometers, or about 0.5 micrometers to about 5 micrometers, or about 1 micrometer to about 3 micrometers (e.g., 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1 .0, 1 .2, 1 .4, 1 .6, 1 .8, 2.0, 2.2
  • the one more porous cartridge pads When present in a test device component, the one more porous cartridge pads sometimes each independently include a circular proximal surface and a circular distal surface.
  • the circular proximal surface and the circular distal surface sometimes independently have a diameter of about 1 millimeter (mm) to about 12 mm, or about 6 mm to about 10 mm, or about 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12 mm.
  • the one or more porous cartridge pads each independently include (i) polyethylene, or (ii) polypropylene, or (iii) polyethylene and polypropylene, or (iv) glass fiber, or (v) other organic or synthetic fibrous pad.
  • the one or more porous cartridge pads each independently have an average (e.g., mean or median) pore size (e.g., pore diameter) of about 0.05 micrometers to about 5 micrometers, or about 0.20 micrometers to about 2 micrometers, or about 0.45 micrometers to about 1 micrometer, or about 0.05, 0.06, 0.07, 0.08, 0.09, 0.1 , 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1 , 2, 3, 4 or 5 micrometers.
  • average pore size e.g., pore diameter
  • the transfer pad and the one or more optional cartridge pads independently include one or more reagents.
  • the one or more reagents can be chosen from an analyte binding agent, buffering agent, surfactant, cell lysis agent, detergent, protein, enzyme, antibody or antigen-binding fragment thereof, antigen, binding pair member, bulking agent, waterabsorbing agent, saccharide, polysaccharide, nucleic acid amplification reagent, nucleic acid and aptamer.
  • An analyte binding agent can be any suitable agent for binding to an analyte for detection in a test strip ⁇ e.g., a nitrocellulose test strip).
  • An analyte binding agent in certain implementations is an antibody or antigen-binding fragment thereof.
  • An analyte binding agent sometimes binds to one of the following non-limiting examples of analytes: a hormone ⁇ e.g., testosterone, cortisol, melatonin); a vitamin ⁇ e.g., vitamin D); an infectious disease antigen; and a polymerase chain reaction nucleic acid amplicon (e.g., generated from and incorporating labeled primers).
  • Any suitable binding pair member for use with a lateral flow strip can be utilized, non-limiting examples of which include antibody/antigen, antibody/antibody, antibody/antibody fragment, antibody/antibody receptor, antibody/protein A or protein G, hapten/anti-hapten, biotin/avidin, biotin/streptavidin, folic acid/folate binding protein, vitamin B12/intrinsic factor, nucleic acid/complementary nucleic acid (e.g., DNA, RNA, PNA) and the like.
  • Any suitable enzyme can be utilized, including but not limited to a ligase, polymerase, transposase, reverse transcriptase.
  • a suitable water-absorbing agent can be utilized, such as a polysaccharide, for example.
  • the transfer pad includes a water-absorbing agent at the distal surface of the pad, and/or in a portion of the pad adjacent to the distal surface of the pad.
  • One or more reagents can be distributed in all or a portion of the transfer pad and/or the one or more optional cartridge pads.
  • a reagent ⁇ e.g., a protein, enzyme, antibody or antigen
  • a detectable label suitable for use with a lateral flow strip
  • fluorescent labels such as organic fluorophores, lanthanide fluorophores (chelated lanthanides; dipicolinate-based Terbium (III) chelators), transition metalligand complex fluorophores ⁇ e.g., complexes of Ruthenium, Rhenium or Osmium); quantum dot fluorophores, isothiocyanate fluorophore derivatives (e.g., FITC, TRITC), succinimidyl ester fluorophores ⁇ e.g., NHS-fluorescein), maleimide-activated fluorophores (e.g., fluorescein-5- maleimide), amidite fluorophores ⁇ e.g., 6-FAM phosphoramidite); protein fluorphores ⁇ e.g., fluorescent labels such as organic fluorophores, lanthanide fluoroph
  • Non-limiting examples of organic fluorophores include xanthene derivatives ⁇ e.g., fluorescein, rhodamine, Oregon green, eosin, Texas red); cyanine derivatives ⁇ e.g., cyanine, indocarbocyanine, oxacarbocyanine, thiacarbocyanine, merocyanine); naphthalene derivatives (dansyl, prodan derivatives); coumarin derivatives; oxadiazole derivatives ⁇ e.g., pyridyloxazole, nitrobenzoxadiazole, benzoxadiazole); pyrene derivatives ⁇ e.g., cascade blue); oxazine derivatives ⁇ e.g., Nile red, Nile blue, cresyl violet, oxazine 170); acridine derivatives ⁇ e.g., proflavin, acridine orange, acridine yellow); arylmet
  • a detectable label sometimes includes a fluorophore or a dye.
  • a lateral flow strip in a test device component can be any type of strip, and of any dimension, suitable for analysis of analytes in sample fluid transmitted from a sample collection device component to the transfer pad and from the transfer pad to the strip.
  • a lateral flow strip also is referred to herein as a test strip.
  • the strip includes nitrocellulose in certain instances, can include one or more associated pads (e.g., polyesters pad, glass fiber pad, absorbent pad) and often includes one or more reagents. Any suitable reagent(s) can be incorporated onto or into a strip and a reagent sometimes is bound (e.g., covalently bound) to the strip.
  • Non-limiting examples of reagents that can be incorporated into or onto a strip include a blocking agent, nucleic acid (e.g., capture oligonucleotide probes, DNA fragment, RNA fragment), a binding pair member, a protein, enzyme, antibody or antigen-binding fragment thereof or antigen or other reagent described herein.
  • nucleic acid e.g., capture oligonucleotide probes, DNA fragment, RNA fragment
  • binding pair member e.g., a binding pair member, a protein, enzyme, antibody or antigen-binding fragment thereof or antigen or other reagent described herein.
  • antibodies or fragments thereof can be utilized for a sandwich assay and protein-hapten conjugates can be utilized for a competitive assay.
  • a test device component sometimes includes a strip pad in contact with the distal terminus of a test strip and/or a region on the anterior and/or posterior surface of the test strip adjacent to the distal terminus of the strip.
  • Such a strip pad generally is porous and absorbent, and can facilitate fluid flow, in the proximal to distal direction, through the strip.
  • a test strip is substituted with another type of detection element, such as an absorbent pad or a matrix disposed on a support (e.g., silica gel, alumina or other matrix coated on a glass, metal, plastic or other support), for example.
  • a sample containing an analyte of interest such as a saliva sample
  • Approximately 0.5-1 ml_ of saliva is collected using the sample collection device.
  • the collection device is then inserted by the user into the test device, where the sample pad is compressed, and the sample is expressed through the filter.
  • the sample collection device is inserted into the test device with an action that mechanically compresses the sample pad, driving the expression of the saliva through the filter, which can be a multi-layered filter stack of two or more layers.
  • the filters which can range from 10um to 0.45um in pore size, can be chemically treated to mitigate non-specific binding of target analytes, thereby ensuring selective passage of analytes of interest, e.g., biomolecules.
  • the transfer pad can include lyophilized reagents (e.g., lyophilized buffer reagents) optimized for sample matrices, such as saliva matrices, which, in aspects, can include antibodies specific for target analytes to be assayed and, in certain aspects, also can include a separate control antibody to ensure the correct operation of the assay.
  • the transfer pad can be impregnated with the lyophilized reagents.
  • the reagents can be engineered to buffer the sample; without being bound by a theory or mechanism, the buffering can, in certain aspects, mitigate potential biochemical interferences and/or enhance the specificity and efficiency of antibody-analyte binding.
  • the antibodies specific to the target analyte and/or the antibodies specific to control antigens/analytes can be gold-labeled.
  • the pad As the pad is rehydrated, it flows from the transfer pad to the nitrocellulose membrane on the lateral flow test strip. As the sample progresses from the transfer pad to the test strip, it is driven through the strip by capillary action in the nitrocellulose membrane. This action facilitates selective interactions between the analyte and the analyte-detecting reagent, such as immunological interactions, at designated test and control lines, which consist of immobilized antibodies, antigens or other analyte-detecting reagents.
  • the lateral flow capillary action wicks the sample mixed with diluted reagents through the test strip, where analyte interactions with an analyte-detecting reagent, such as an antibody, (e.g., binding to an analyte-detecting reagent, such as an antibody) occur with the target analyte in the sample, resulting in the presence of a control line and the presence or absence of a test line forming on the test strip.
  • an analyte-detecting reagent such as an antibody
  • binding to an analyte-detecting reagent such as an antibody
  • This lateral flow technology can detect a wide range of analytes, from hormones to pathogens and various pharmacological agents.
  • the detection range depends on the nature of the analyte, exemplary non-limiting ranges being from about the 0.5 ng/ml to about 50 ng/ml with visual detection and about 5 pg/ml to about 50 ng/ml using a reader.
  • a portion of the transfer pad that is disposed adjacent to a portion of the strip, and (ii) the portion of the test strip disposed adjacent to the portion of the transfer pad are separated.
  • the portions (i) and (ii) are separated by a removable barrier, where the removable barrier is disposed between the portion of the transfer pad (i) and the portion of the test strip adjacent to the transfer pad (ii).
  • a portion of the transfer pad posterior surface is disposed opposite a portion of the test strip anterior surface, and the removable barrier is disposed between the portion of the transfer pad posterior surface and the portion of the test strip anterior surface opposite to the portion of the transfer pad posterior surface.
  • the removable barrier can be a pull tab.
  • a pull tab sometimes is manufactured from a flexible and thin and non-porous material, such as plastic, for example.
  • a pull tab can include any suitable plastic, including without limitation polyethylene terephthalate (PET), low density polyethylene (LDPE), medium density polyethylene (MDPE), polypropylene (PP), vinyl, polyvinyl chloride (PVC), or combination thereof (e.g., a pull tab can be punched from a plastic sheet).
  • PET polyethylene terephthalate
  • LDPE low density polyethylene
  • MDPE medium density polyethylene
  • PP polypropylene
  • PVVC polyvinyl chloride
  • a portion of the test device housing includes a slot through which a portion of the removable barrier protrudes and extends from an exterior surface of the test device housing.
  • a button is disposed in the test device housing opposite the portion of the transfer pad disposed adjacent to the portion of the test strip.
  • a portion of the transfer pad posterior surface is disposed opposite a portion of the test strip anterior surface, and the button is disposed opposite the portion of the transfer pad.
  • a button sometimes is defined by slits in the test device housing. In certain instances, the button is defined by three slits in the test device housing and a portion of the test device housing sidewall opposite one of the slits functions as a living hinge.
  • a living hinge portion can include a kerf that facilitates operation of the living hinge, and a device housing sometimes includes no kerf at the living hinge.
  • a button can be disposed on an anterior portion of the test device housing.
  • the test device housing includes an extension bar extending from an interior surface of the button and the test device housing, which includes a poster surface. The posterior surface of the extension bar often is disposed opposite the portion of the transfer pad disposed adjacent to the test strip. The posterior surface of the extension bar sometimes contacts a portion of the anterior surface of the transfer pad and sometimes the posterior surface of the extension bar is spaced from the anterior surface of the transfer pad.
  • the test device housing includes a catch, and the extension bar includes a catch counterpart (e.g., a depression or projection disposed in or on a side of the extension bar) disposed adjacent to the catch in the test device housing.
  • test device component 100 illustrated in FIG. 1 and FIG. 4A to FIG. 1 1 .
  • Test device component 100 includes test device housing 101 illustrated in FIG. 1 , for example.
  • Test device housing 101 includes a cylindrical first region 195, a lateral planar cylindrical segment second region 197 and a lateral arcoid cylindrical segment third region 196 disposed between the first region and the second region, as illustrated in FIG. 10.
  • test device housing 101 includes posterior member 102 (also referred to as test device housing (bottom)), anterior member 103 (also referred to as test device housing (top)), and junction 104 between the posterior member and the interior member.
  • Test device housing 101 , posterior member 102 and anterior member 103 each include a proximal terminus (105, 105a, 105b), a distal terminus (106, 106a, 106b) and wall exterior surface (108a, 108b, 108c, 108d for anterior member 103 and 109a, 109b, 109c for posterior member 102).
  • a number of features align and connect posterior member 102 and anterior member 103 in test device housing component 101.
  • Edge members of anterior member 103 fit into and contact edge members of posterior member 102.
  • Edge members of anterior member 103 include recessed protrusion 113, having edge 1 13a and a surface 1 13b adjacent to recessed protrusion 113.
  • Edge members of posterior member 102 include edge 116, recessed edge 117 and sidewall 118 between edge 116 and recessed edge 117.
  • Surface 1 13b of anterior member 102 contacts sidewall 118 of posterior member 102, which in part constricts lateral and transverse movement of anterior member 103 relative to posterior member 102.
  • Connectors in anterior member 103 connect to connector counterparts in posterior member 102 (receptacles 184a, 184b, 184c, 184d) and in part restrict longitudinal movement of anterior member 103 relative to posterior member 102.
  • a subset of connectors of anterior member 103 is disposed on edge 113a (connector 114a), and another subset of connectors of anterior member 103 is disposed on interior sidewall 121c (connector 1 14b).
  • a subset of connectors of posterior member 102 is disposed on edge 116 and another subset of connectors of posterior member 103 is disposed on connector posts 183a, 183b, 183c, 183d (receptacles 183a, 183b, 183c, 183d).
  • Posterior member 102 of test device housing 101 includes window 110 (also referred to as results viewing window) defined by recess 112.
  • Recess 112 is in part defined by interior wall surfaces 112a and 112b and by the wall thickness disposed at window 1 10 (108b and 108d), as illustrated, for example in FIG. 4E.
  • Test device housing 100 includes proximal opening 120 (also referred to as a sample collector port), at which test device housing proximal opening rim 135 is disposed.
  • Test device housing 100 includes proximal opening 120 (also referred to as a sample collector port), at which test device housing proximal opening rim 125 is disposed in anterior member 103 and test device housing proximal opening rim 135 is disposed in posterior member 102.
  • Rim member 125 steps to interior surface 121 (121a, 121 b, 121c).
  • Rim member 135 steps to interior surface 131 (131 a, 131 b).
  • extension bar 127 Projecting also from interior surface 121 of anterior member 103 is extension bar 127, having posterior edge 127', distally-disposed face 127" and side edge 127"'.
  • the major dimension of posterior edge 127' is transversely oriented, and the transverse length of the proximally-disposed face and the distally-disposed face of extension bar 127 at edge 127' is the major dimension of extension bar 127.
  • the transverse length of edge 127' of extension bar 127 is parallel to transverse axis 194 illustrated in FIG. 4D.
  • first extension wall 154 Projecting from interior surface 151 of posterior member 102 is excess sample port 152. Also projecting from interior surface 151 of posterior member 102 is excess sample reservoir 153. Projecting also from interior surface 151 of posterior member 102 is second cartridge terminal projection recessed wall 154. The transverse length of the edge of first extension wall 154 is parallel to transverse axis 194 illustrated in FIG. 4D. Side of the first extension wall 154 is longitudinally oriented (/'.e., parallel to longitudinal axis 199 shown in FIG. 10).
  • each of containment posts 181 a and 181 b Projecting from interior surface 186 (and 186a) of posterior member 102 are containment posts 181 a and 181 b configured to retain a lateral flow strip and constrain transverse movement of the strip.
  • the longitudinally disposed length of each of containment posts 181 a and 182b is the major post dimension and the anterior terminal face of each post has a triangular profile.
  • a point of the triangular profile faces the transverse center of posterior member 102 (designated by callout 151 ), and the triangular point facing the transverse center of each of posts 181a and 181 b is spaced from the transverse center by a distance equal to half or about half of the transverse width of the lateral flow strip contained by the containment posts.
  • the triangular point of each of posts 181 a and 181 b facing the transverse center extends as a longitudinally disposed edge also facing the transverse center of posterior member 102.
  • support ribs 182a, 182b, 182c and 182d Projecting also from interior surface 186 (and 186a) of posterior member 102 are support ribs 182a, 182b, 182c and 182d, having support rib edges 182a', 182b', 182c' and 182d', respectively.
  • Support ribs 182a and 182b are configured to contact posterior surface 185d of lateral flow strip 185.
  • the major dimension of anterior edge 182a' of support rib 182a is laterally disposed, and the major dimension of anterior edge 182b' of support rib 182b is laterally disposed.
  • Anterior edge 182a' and anterior edge 182b' typically are disposed at the same longitudinal height relative to the interior surface 186a from which ribs 182a and 182b project.
  • support rib 182a opposes the transverse center of posterior member 102 (designated by callout 151 ) and is referred to as an internal face.
  • the other face of rib 182a opposing the internal face is referred to as an external face.
  • the face of support rib 182b opposing the internal face of support rib 182a also opposes the transverse center of posterior member 102 and is referred to as an interior face.
  • the other face of rib 182b opposing the internal face is referred to as an external face.
  • each of ribs 182a and 182b is spaced from the transverse center by a distance that is the same or about the same from the proximal terminus to the distal terminus of each of ribs 182a and 182b.
  • the longitudinally disposed edge facing the transverse center of posterior member 102 of containment posts 181a can contact the external face of support rib 182a.
  • the longitudinally disposed edge facing the transverse center of posterior member 102 of containment posts 181 b can contact the external face of support rib 182b.
  • Anterior edge 182a' and anterior edge 182b' typically are disposed at the same longitudinal height relative to the interior surface 186a from which ribs 182a and 182b project.
  • Support ribs 182c and 182d are integrated with and extend from (i) interior surface 186a and (ii) the interior surface of the distal terminus of posterior member 102.
  • Support rib 182c is adjacent to support rib 182b with the internal face of rib 182c opposing the external face of rib 182b.
  • the internal face of rib 182c sometimes contacts the external face of rib 182b and sometimes is spaced from the external face of rib 182b.
  • Support rib 182d is adjacent to support rib 182a with the internal face of rib 182d opposing the external face of rib 182a.
  • the internal face of rib 182d sometimes contacts the external face of rib 182a and sometimes is spaced from the external face of rib 182a.
  • anterior edge 182c' and anterior edge 182d' The major dimension of each of anterior edge 182c' and anterior edge 182d' is laterally disposed.
  • Anterior edge 182c' and anterior edge 182d' typically are disposed at the same longitudinal height relative to the interior surface 186a from which ribs 182c and 182d project.
  • Anterior edge 182c' and 182d' typically are raised (/.e., are proud) with respect to anterior edge 182a' and anterior edge 182b'.
  • Support ribs 182c and 182d are configured to guide the test strip during assembly and retain the test strip after assembly in its intended position.
  • cartridge housing 170 (also referred to as a sample process cartridge housing).
  • the entirety of cartridge housing 170 resides in test device housing 101 of test device component 100.
  • a portion of a cartridge can be disposed outside of test device housing 101 .
  • cartridge housing 170 includes proximal terminus 171 with proximal edge 171 a, distal terminus 172 and sidewall 173, with sidewall exterior surface 173a and interior surface 173b.
  • Cartridge housing 170 is a tube defined by circular cross sections, is hollow and includes an interior lumen (173d, 173e). The cross-sectional diameter of cartridge housing 170 reduces from proximal terminus 171 to distal terminus 172.
  • Cartridge housing 170 includes two frustum portions.
  • a proximally disposed first frustum portion is defined by sidewalls having a first exterior draft angle
  • another distally-disposed second frustum portion contiguous with the first frustum portion is defined by sidewalls having a second exterior draft angle, where the second draft angle is greater than the first draft angle.
  • the first frustum portion transitions to the second frustum portion at sidewall transition 173c, and a cross-sectional diameter in the first frustum portion is greater than a cross-sectional diameter in the second frustum portion.
  • terminal wall 175 (also referred to as a restriction structure), having exterior surface 175a and interior surface 175b. Interior surface 175a of terminal wall 175 is coextensive and integrated with sidewall interior surface 173b at distal terminus 172 of the cartridge housing.
  • the diameter of terminal wall 175 (exterior diameter and interior diameter) is transversely disposed (i.e., parallel to transverse axis 194 shown in FIG. 4D). While the interior diameter of terminal wall interior surface 175b defines a terminal wall surface area between 60 square millimeters (mm) and 61 square mm in cartridge housing 170, the interior wall surface area of a terminal wall can have any suitable surface area.
  • Terminal wall 175 includes bores 177a and 177b that traverse the entire thickness of the terminal wall and include an aperture on each of interior surface 175b and interior surface 175a. At least a portion of the surface area, or the entire surface area, of each of bores 177a and 177b is aligned with interior 179 of terminal projection 174. While bores 177a and 177b each are defined at terminal wall 175 by a predominantly rectilinear perimeter with one curved side, the bores can be defined by any suitable perimeter that permits transmission of sample fluid in the proximal to distal direction from the cartridge housing.
  • each of bores 177a and 177b at terminal wall 175 has a bore surface area between 6 square millimeters (mm) and 7 square mm, for a combined bore surface area between 12 square mm and 14 square millimeters, for cartridge housing 170, any suitable bore surface area can be implemented for transmission of sample fluid in the proximal to distal direction from the cartridge housing.
  • the ratio of (i) the combined bore 177a and 177b surface area to (ii) the surface area of the terminal wall interior surface 175b is between about 0.20 to about 0.23.
  • cartridge terminal projection 174 Extending from distal terminus 172 and from terminal wall 175 exterior surface 175a of cartridge housing 170 is cartridge terminal projection 174, having proximal terminus 176a and distal terminus 176b. Terminal projection 174 is a hollow tube and is configured to retain a portion of transfer pad 165.
  • Transfer pad 165 (also referred to as a transport pad) has a rectangular cuboid geometry, having proximal terminus (proximal surface) 166, distal terminus (distal surface) 167, anterior surface 168a and posterior surface 168b, and side surfaces 169 bounded by the foregoing transfer pad surfaces, as illustrated in FIG. 8.
  • Terminal projection 174 has a rectangular cross section for retaining transfer pad 165, and includes posterior side member exterior surface 176c, anterior side member exterior surface 176d, side member exterior surface 176e and interior 179. While the portion of transfer pad 165 disposed within interior 179 of terminal projection 174 is retained by an interference fit, the transfer pad could be retained in any other suitable manner (e.g., weld and the like).
  • Cartridge housing 170 includes a first cartridge housing pad 145 (also referred to as filtration/chemistry pad) which, in aspects, is in a discrete unit that is separated from the sample collection pad.
  • Cartridge housing pad 145 is proximally disposed with respect to, and contacts, an optional second cartridge housing pad 146 (also referred to as conjugate/chemistry pad).
  • Each cartridge housing pad is dimensioned to fit within the cartridge housing interior with a side of each pad contacting a portion of sidewall interior surface 173b.
  • Each cartridge housing pad is porous and at least a continuous annular portion of the side of each pad typically continuously contacts an annular portion of interior sidewall surface 173b.
  • First cartridge housing pad 145 includes proximal surface 145a, distal surface 145b and side surface 145c.
  • Second cartridge housing pad 146 includes proximal surface 146a, distal surface 146b and side surface 146c.
  • distal surface 145b of first cartridge housing pad contacts proximal surface 146a of second cartridge housing pad 146
  • distal surface 146b of second cartridge housing pad 146 contacts interior surface 175b of terminal wall 175.
  • test device component 100 orientation of test device housing 101 , cartridge housing 170, cartridge housing pads 145 and 146, terminal projection 174 and transfer pad 165, and lateral flow test strip 185 is illustrated, for example, in FIGS. 8, 9A and 14B.
  • Cartridge housing 170 is retained within the interior of test device housing 101.
  • Cartridge housing proximal edge 171 a contacts test device housing rim 135 (and 125), thereby constraining lateral movement of the cartridge.
  • Annular groove 178c is formed between test device housing 101 and recessed surface 178a of cartridge housing 170, in which rim surface 178b forms the floor of annular groove 178c.
  • Annular groove 178c functions as a connector member counterpart that receives stem annular protrusion 218 connector member of sample collection device 200.
  • Test strip 185 (also referred to as a lateral flow strip) is disposed adjacent to transfer pad 165, and includes proximal terminus 185a, distal terminus 185b, anterior surface 185c and posterior surface 185d. A proximally disposed portion of anterior surface 185c of test strip 185 contacts a distally disposed portion of posterior surface 168b of transfer pad 165 at a transfer pad-test strip interface. Test strip absorbent pad 188 contacts a distally disposed portion of anterior surface 185c of test strip 185, and without being limited by theory, facilitates fluid transmission through test strip 185.
  • a sample collection unit that is in a non-horizontal orientation relative to a horizontally oriented sample transport pad and test strip
  • a filter housing unit or cartridge that is discrete and separate from the sample collection unit, or an excess sample reservoir into which excess fluid from the transport pad is drained
  • FIGS. 15-20 Certain aspects of the device described in in U.S. Patent Application No. 17/576,346, which published as U.S. Application Publication No. US20220249073 and can be modified as provided herein, are depicted in FIGS. 15-20.
  • composition or kit that includes: a sample collection device component described herein, and a test device component described herein, where the sample collection device is separate from the test device and is not joined or connected to the test device.
  • the sample collection device is configured to join to the test device, but the sample collection device is not joined and is physically separated from the test device in the composition or kit.
  • a composition or kit can include any suitable number of separate containers or compartments, and in certain implementations, the sample collection device and the test device are in separate compartments and/or containers.
  • a container can be any suitable container for storing a test device or sample collection device for a period of time, including for example rigid, semi-rigid or flexible containers e.g., a flexible bag that optionally can be sealed).
  • a kit or composition can include one or more reagents described herein, and in certain implementations, contains a reader device suitable for detecting presence, absence and/or amount of a detectable signal emitted from a test device lateral flow strip through a test device housing window.
  • a kit or composition can include instructions for carrying out an assembly process or method of using a sample collection device and/or test device as described herein. Instructions and/or descriptions may be in tangible form e.g., paper and the like) or electronic form (e.g., computer readable file on a tangle medium e.g., memory device)) and may be included in a kit insert.
  • a kit may include a written description of an internet location that provides such instructions or descriptions.
  • sample pad of the sample collection device component generally is compressible as described herein.
  • sample collection device handle distal terminus is configured to contact the test device housing proximal terminus for when the test device and sample collection device are joined (e.g., connected, sealingly connected, in locked connection).
  • a lateral distance between the sample collection device handle distal terminus and the sample pad distal terminus is a first lateral distance; a lateral distance (i) between the test device housing proximal terminus and the interior surface of the cartridge housing terminal wall, or (ii) between the test device housing proximal terminus and a proximal surface of a cartridge housing pad where the cartridge housing contains a cartridge housing pad, is a second lateral distance; and the first lateral distance is greater than the second lateral distance.
  • an assembly that includes a sample collection device component described herein and a test device component described herein, where the sample collection device is joined with the test device (e.g., connected, sealingly connected, in locked connection).
  • the test device generally is distally disposed from the sample collection device handle, and the sample pad and at least a portion of the stem of the sample collection device often are contained within the test device.
  • the sample pad and at least a portion of the stem of the sample collection device often are disposed within the interior of the cartridge housing of the test device.
  • the sample pad generally is laterally compressed in the assembly relative to the lateral length of the sample pad when the sample collection device and the test device are separate and not joined.
  • the lateral length between the sample pad proximal terminus and the sample pad distal terminus in the sample collection device not joined to the test device is a first lateral distance
  • a lateral length between the sample pad proximal terminus and the sample pad distal terminus in the sample collection device joined to the test device is a second lateral distance
  • the first lateral distance is greater than the second lateral distance.
  • the second lateral distance sometimes is about 50% to about 90% of the first lateral distance, or about 60% to about 85% of the first lateral distance, or about 70% to about 80% of the first lateral distance, or about 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% or 95% of the first lateral distance.
  • the sample pad generally is compressed when the sample collection device and the test device are connected, for example in sealing connection and/or in locked connection.
  • the sample pad often is a single pad.
  • the midpoint of (i) is concentric with the midpoint of (ii); or the midpoint of (ii) is concentric with the midpoint of (iii); or the midpoint of (i), the midpoint of (ii) and the midpoint of (iii) are concentric.
  • the latter orientations can permit linear sample fluid transfer from the sample pad to the transport pad. In certain aspects, such transfer is by passive wicking.
  • excess sample fluid is drained into an excess sample reservoir. In aspects, the excess sample reservoir is located behind the transport pad.
  • an effective outer diameter of a compressed sample pad is defined as a minimum cross-sectional diameter that fits the entire cross-section of a deformed sample pad from the proximal terminus to the distal terminus of the sample pad.
  • the minimum interior transverse diameter of a cartridge housing lumen portion in which the sample pad resides is equal to or greater than the sample pad effective outer diameter.
  • the minimum interior transverse diameter of the cartridge housing lumen portion in which the sample pad resides sometimes is 0.01% to 50% greater than the sample pad effective outer diameter.
  • the sample collection device is in connection with the test device (e.g., sealing connection, locked connection).
  • a connection sometimes is reversible and sometimes is irreversible (/.e., locked connection) under a tool-less lateral pulling force generated by a human of average strength.
  • the sample collection device includes a connector member disposed on the stem; the test device includes a connector member counterpart disposed on an interior surface of the test device; and the connector member of the sample collection device is connected to the connector member counterpart of the test device.
  • the sample collection device includes a connector member disposed in the handle; the test device includes a connector member counterpart disposed on an exterior surface of the test device; and the connector member of the sample collection device is connected to the connector member counterpart of the test device.
  • the connector member of the sample collection device sometimes is an annular projection, and the connector member counterpart of the test device sometimes is an annular groove, where the annular projection is disposed in the annual groove.
  • the connector member of the sample collection device sometimes includes a threaded member, and sometimes the connector member counterpart of the test device includes a threaded member that engages the threaded member of the sample collection device.
  • a threaded member of a sample collection device sometimes is disposed on an interior surface of the handle and a threaded member of the test device sometimes is disposed on a hollow shank extending from the cartridge and from the proximal terminus of the test device housing.
  • the sample collection device is in sealing engagement and/or in sealing connection with the test device.
  • a sealing member sometimes is disposed at a stem of a sample collection device, where the sealing member sometimes is in sealing contact with (i) a sealing member counterpart disposed at an interior wall surface of the test device, or (ii) an interior wall surface of the test device.
  • a sample pad of a sample collection device includes sample fluid, as described herein.
  • Sample fluid typically transmits from the sample pad of the sample collection device to the transfer pad in the test device and from the transfer pad to the test strip in the test device.
  • An assembly often includes a sample expression zone that contains a sample pad compression zone, a sample transfer zone distally disposed relative to the sample expression zone, and a sample readout zone distally disposed relative to the sample expression zone. Sample fluid often transmits from the sample pad in the sample compression zone, often transmits to and from the transfer pad in the sample transfer zone and transmits through the test strip in the sample readout zone.
  • sample fluid typically transmits from the sample pad of the sample collection device through one or more bores disposed in the terminal wall of the cartridge housing, and sample fluid then often transmits to the transfer pad in the sample transfer zone.
  • sample fluid sometimes transmits from the sample pad of the sample collection device, through one or more cartridge housing pads, then through one or more bores disposed in the terminal wall of the cartridge housing, and then to the transfer pad.
  • compression of the sample pad generates a back pressure that expresses fluid from the sample pad and motivates transmission of the expressed sample fluid through the test device, from the sample pad to one or more cartridge housing pads when present in a test device, to the transfer pad through one or more bores in the terminal wall of the cartridge housing, and from the transfer pad to the test strip.
  • compression of the sample pad functions as a virtual plunger that motivates sample fluid to express from the sample pad and transmit laterally in the proximal to distal direction through the test device.
  • metering of sample fluid in the test device generally is governed in part (i) by the size, porosity and retention volume of the sample pad of the sample collection device, and (ii) by the size, porosity and retention volume of the transfer pad of the test device.
  • the retention volume of the transfer pad generally serves to meter the amount of fluid transmitted to the test strip.
  • the retention volume of the of the transfer pad generally is less than the volume capacity of the sample pad, accounting for sample fluid retained by the sample pad and any cartridge housing pad(s) or excess sample reservoirs.
  • sample fluid is expressed from the sample pad, transmitted laterally in the proximal to distal direction through the test device in an amount metered by the sample pad to the one or more optional cartridge housing pads and to the transfer pad, and in an amount metered by the transfer pad to the test strip.
  • Metering of sample fluid volume within the test device without requiring action by an operator other than joining the sample collection device component to the test device component advantageously provides for controlling the ratio of sample fluid volume to reagents and other components in pads and/or the test strip, thereby significantly reducing variance of test results caused by operator error and increasing ease of use.
  • sample fluid is processed in the test device prior to transmission to the test strip.
  • processing sometimes includes retaining certain sample fluid components in the sample pad and/or optional cartridge housing pad(s) (retaining mucins, e.g., high molecular weight mucins and/or low molecular weight mucins) and/or contacting sample fluid with one or more reagents in the sample pad, optional cartridge housing pad(s) and/or transfer pad.
  • sample fluid is processed in the test device without prior sample fluid processing by an operator, thereby significantly reducing variance of test results caused by operator error and enhancing ease of use.
  • a single step of joining the sample collection device component to the test device component allows for integration of sample fluid processing steps within the test device, thereby obviating or reducing the number of prior processing steps such as prior freezing or thawing of sample fluid, prior filtration of sample fluid (i.e., unprocessed, native sample can be collected on the sample pad and introduced to the test device) and/or prior contact of sample fluid with one or more reagents, for example.
  • rate of fluid flow from the sample pad through the test device is in part governed by (i) the degree of sample pad compression, (ii) the surface area of bores in the cartridge housing terminal wall, (iii) porosity of the transfer pad, and (iv) fluid transfer rate of the test strip.
  • a higher degree of lateral sample pad compression can generate a higher amount of back pressure and a higher flow rate of sample fluid from the sample pad, relative to a flow rate associated with a lower degree of lateral sample pad compression.
  • Bore size can be expressed in terms of a ratio between the overall bore surface area (e.g., combined surface area of multiple bores) to the surface area of the interior surface of the terminal wall of the cartridge housing that contains the bore(s), as described herein.
  • a higher ratio can result in a lower sample fluid flow rate as compared to a flow rate associated with a relatively lower ratio.
  • a higher transfer pad porosity can result in a higher sample fluid flow rate compared to a flow rate associated with a lower transfer pad porosity.
  • the degree of sample pad compression, bore surface area in the cartridge housing terminal wall, and transfer pad pore size typically are optimized for (i) efficient sample fluid loading into the transfer pad, and (ii) sufficient time for reagents present in pads and/or on the strip to interact with sample fluid prior to sample fluid migration to a detection zone on the strip in the test device, for example.
  • the rate of sample fluid flowing through an assembly also can be optimized by inclusion of one or more fluid flow rate modulating agents in one or more pads of a device described herein.
  • a water-absorbing agent can be included in one or more pads that can reduce a fluid flow rate.
  • a water-absorbing agent can absorb water when sample fluid contacts the agent and the act of water absorption can reduce flow of the sample fluid.
  • a water-absorbing agent can be included in a portion of a transfer pad in certain implementations (e.g., a water-absorbing agent can be included in a portion of transfer pad disposed adjacent to the distal terminus of the pad).
  • Efficient sample fluid loading into the transfer pad generally results in sample fluid expressed from the sample pad absorbing into the transfer pad at a rate that (i) maximizes the amount of the sample fluid transferred from the transfer pad to the strip, and (ii) eliminates or reduces the amount of fluid exiting the transfer pad into a portion of the test device interior not in the strip (referred to herein as residual sample fluid).
  • residual sample fluid An excess sample reservoir, extension structures (such as the extension walls as described herein), or a combination thereof can serve as containment structures for excess or residual sample fluid.
  • Figure 14B shows the assembly with collection device 200 fully inserted through the test device housing anterior rim opening 135 with the sample pad 230 having been compressed against the test device barrel posterior wall 160d.
  • the insertion of the collection device 200 and equivalent lateral compression of the sample pad 230 as shown in the figure as 290b forces the sample to be expressed through the test device barrel posterior bore 160e through the test device cartridge housing 170 which houses the first and second cartridge housing pads 146 and 145 that filter the sample and deliver it through the cartridge housing terminal wall bore 177a 177b to the transfer pad 165 held in the first cartridge terminal projection 174 where the dried chemistry is located.
  • Excess sample not absorbed into the transfer pad 165 is passed through the second cartridge terminal projection 178 and through the second cartridge terminal projection recessed wall 154 where the sample is transferred and stored in the excess sample reservoir 153.
  • Sample absorbed into the transfer pad 165 is retained and incubated for a predetermined time until the pull tab 790 is removed, permitting contact of the transfer pad 165 to the test strip 185 allowing the test strip 185 to wick sample from the transfer pad 165 through the tests strip 185 by capillary action.
  • test lines are visualized on the test strip 185 and seen through the test device housing window 110.
  • a pull tab 790 is not present. In aspects, when a pull tab is not present, sample fluid will run onto test strip 185 once the transfer pad 165 is saturated.
  • FIG. 21 is a non-limiting example of a set of representative dimensions of the sample collection device 200.
  • FIGS. 22 and 23 are non-limiting examples of sets of representative dimensions of the test device 100.
  • FIGS. 24 and 25 are non-limiting examples of sets of representative dimensions of the test assembly 300.
  • the test assembly as represented by FIG. 25 has the dimensions of the test device as represented by FIG. 23.
  • the test assembly as represented by FIG. 24 has the dimensions of the test device as represented by FIG. 22.
  • the test assembly as represented by FIG. 25 has the dimensions of the test device as represented by FIG. 23 and the dimensions of the sample collection device as represented by FIG. 21 .
  • the test assembly as represented by FIG. 24 has the dimensions of the test device as represented by FIG. 22 and the dimensions of the sample collection device as represented by FIG. 21 .
  • a method for preparing an assembly that includes joining a sample collection device described herein to a test device component described herein, thereby forming the assembly.
  • the joining generally includes inserting the collection device into the interior of the cartridge housing, and often includes inserting in a lateral direction and in the proximal to distal direction, a portion of the sample collection device component containing at least a portion of the sample pad into the interior of the cartridge housing the test device component.
  • the stem or portion thereof of the sample collection device component often is inserted into the interior of the cartridge housing.
  • An operator typically grasps the handle of the sample collection device component, after sample fluid is absorbed into the sample pad, and inserts in a lateral motion, in the proximal to distal direction, a portion of the sample collection device component containing at least a portion of the sample pad through the test device housing proximal opening, and into the interior of the cartridge housing, of the test device component.
  • Inserting a portion of a sample collection device in the lateral direction and in the proximal to distal direction sometimes is a slidable insertion, and sometimes includes twisting or rotation of the sample collection device around a virtual central lateral axis. Sometimes slidable insertion of the sample collection device does not include twisting or rotation of the sample collection device around a virtual central lateral axis.
  • the sample pad of the sample collection component device that is joined to the test device component often contains sample fluid.
  • the sample pad of the sample collection device component generally is contacted with sample fluid under conditions in which the sample pad absorbs sample fluid prior to joining the sample collection device component to the test device component.
  • a property of the sample pad of the sample collection device sometimes changes upon contact with the sample fluid, indicating to an operator that a sufficient amount of sample fluid has been absorbed into the sample pad.
  • a sample collection device sometimes is joined to a test device without further manipulation of the sample collection device, or After a change is detected or observed in such implementations, a sample collection device sometimes is placed in a sealable container (e.g. rigid container, a flexible bag), the container is sealed, and then the collection device is later removed from the container and joined to a test device.
  • a sealable container e.g. rigid container, a flexible bag
  • Joining of the sample collection device component to the test device component often is completed when the sample collection device component is connected to the test device component. Joining of the sample collection device component to the test device component often is completed when the sample collection device component is sealingly connected to the test device component.
  • Joining of the sample collection device component to the test device component often is completed when the sample collection device component is in locked connection with the test device component, where joining the sample collection device to the test device includes engaging a connector member of the sample collection device with a connector member counterpart of the test device.
  • a connector member and a connector member counterpart sometimes are engaged by an interference fit or sometimes by a threaded fit, and sometimes the connection is reversible or is a locked connection.
  • engaging the connector member and the connector member counterpart emits an audible sound, indicating to an operator that the members are connected and joining is complete.
  • the sample pad of the sample collection device generally is laterally compressed within the cartridge housing of the test device.
  • sample fluid contained in the sample pad is expressed from the sample pad. Without being limited by theory, compression of the sample pad generates a back pressure that expresses fluid from the sample pad in a sample expression zone of the test device and motivates transmission of the expressed sample fluid through the test device, as described herein.
  • the sample pad retains components in the sample fluid, and sample fluid expressed from the sample pad includes an amount of the components less than the amount in the sample fluid applied to the sample pad and absorbed in the sample pad prior to expression of sample fluid from the sample pad in the test device component.
  • the sample pad retains high molecular weight mucins and the sample fluid expressed from the sample pad includes an amount of the high molecular weight mucins lower than the amount in the sample fluid applied to the sample pad.
  • High molecular weight mucins generally have a molecular weight of 500 kiloDaltons or greater. Without being limited by theory, reducing mucin content in sample fluid transmitted to the test strip and/or transfer pad advantageously reduces sample fluid viscosity.
  • sample fluid After sample fluid is expressed from the sample pad of the sample collection device component in a sample expression zone, sample fluid transmits laterally in the proximal to distal direction from the sample pad to a transfer pad in the test device component, and from the transfer pad to a test strip in the test device.
  • the sample fluid typically transmits from the sample pad of the sample collection device through one or more bores disposed in the terminal wall of the cartridge housing, to the transfer pad distally-disposed with respect to the terminal wall.
  • sample fluid expressed by the sample pad of the sample collection device transmits through one or more cartridge housing pads, then through one or more bores disposed in the terminal wall of the cartridge housing, then to the transfer pad and then to the test strip.
  • sample fluid transmits in the proximal to distal direction from the sample pad to the one or more cartridge housing pads and then to the transfer pad, and then transmits in the anterior to posterior direction from the transfer pad to a proximal region of the test strip disposed at a transfer pad-test strip interface.
  • sample fluid transmits from the sample pad, after the sample collection device is joined (e.g., connected, sealingly connected, in locked connection, completely joined), to the test device (/'.e., time zero), to the sample readout zone (e.g., on the test strip opposite the window of the test device housing) in about 1 minute to about 30 minutes depending on the assay(s) conducted by the test device.
  • input sample fluid enters a particular pad in the test device component and output sample fluid is transmitted (/.e., outputted) from the pad.
  • at least one of the one or more optional cartridge housing pads sometimes retains one or more components in the input sample fluid, and sample fluid outputted from the at least one of the one or more cartridge housing pads includes an amount of the one or more components less than the amount in the input sample fluid.
  • the at least one of the one or more optional cartridge housing pads retains low molecular weight mucins and the sample fluid outputted by the optional pads includes an amount of the low molecular weight mucins lower than the amount of the low molecular weight mucins in the input sample fluid.
  • Low molecular weight mucins have a molecular weight of 300 kiloDaltons or less. Without being limited by theory, reducing mucin content in sample fluid transmitted to the test strip and/or transfer pad advantageously reduces sample fluid viscosity.
  • one or more of the pads of the sample collection device and the test device includes one or more reagents that interact with the sample fluid (e.g., bind to an analyte in the sample fluid).
  • Sample fluid often is aqueous.
  • the one or more reagents are in dry form or semi-hydrated form and interact in solution with the sample fluid when the sample fluid enters the pad.
  • at least a portion of the one or more reagents dissolves into the input sample fluid in or on the pad or test strip.
  • one or more dry or semi-hydrated reagents present hydrate and mix with the sample fluid by turbulence.
  • Sample fluid generally transmits from a portion of the transfer pad to a portion of the test strip.
  • sample fluid transmits from a portion of a posterior surface of the transfer pad to a portion of an anterior surface of the test strip opposite the portion of the transfer pad (e.g., at a transfer pad-test strip interface).
  • the portion of the transfer pad and the portion of the transfer strip sometimes are in direct contact prior to joining the sample collection device to the test device.
  • the distally disposed portion of posterior surface 168b of transfer pad 165 contacts a proximally disposed portion of anterior surface 185c of test strip 185, at a transfer pad-test strip interface, prior to and after sample collection device component 200 is joined to test device component 100, in assembly 300.
  • the portion of the transfer pad and the portion of the test strip are not in direct contact prior to, and after, joining the sample collection device to the test device, and the portion of the transfer pad and the portion of the test strip are placed in direct contact after the sample collection device is joined to the test device.
  • the portion of the transfer pad and the portion of the test strip sometimes are placed in direct contact after an amount of time elapses after the sample collection device is joined to the test device.
  • the portion of the transfer pad and the portion of the test strip are separated by a removable barrier (e.g., a pull tab described herein) prior to, and after, joining the sample collection device to the test device, and the portion of the transfer pad and the portion of the test strip are placed in direct contact after the sample collection device is joined to the test device by removing the portion of the removable barrier disposed at the transfer pad-test strip interface.
  • An operator can remove the portion of the removable barrier (e.g., pull tab described herein) disposed between the portion of the transfer pad and the portion of the test strip after a period of time elapses from the time the sample collection device is joined to the test device component (i.e., a time period that elapses from time zero described herein).
  • the removable barrier e.g., pull tab described herein
  • the removable barrier sometimes is retained in the test device component after a portion of it is removed from between the portion of the transfer pad and the portion of the test strip, and sometimes the removable barrier is separated from the test device component.
  • the portion of the transfer pad and the portion of the test strip are separated prior to, and after, joining the sample collection device to the test device, and the portion of the transfer pad and the portion of the test strip are placed in direct contact after the sample collection device is joined to the test device by operating a button present in the test device housing.
  • the button is depressed in the anterior to posterior direction, and a portion of the device housing in contact with, or placed in contact with, an anterior surface of the transfer pad opposite the portion of the test strip after the button is depressed causes the portion of the transfer pad to contact the portion of the test strip.
  • the portion of the device housing in contact with, or placed in contact with, the anterior surface of the transfer pad sometimes is an extension bar extending from an interior surface of an anterior portion of the test device housing sidewall.
  • An operator can depress the button after a period of time elapses from the time the sample collection device is joined to the test device component (i.e., a time period that elapses from time zero described herein).
  • An operator sometimes depresses the button for a sustained period of time.
  • an operator depresses the button and a catch in the test device component retains the button in a depressed configuration after an operator has depressed the button.
  • a method for determining presence or absence and/or amount of an analyte in a sample that includes: detecting a detectable signal from a lateral flow strip through a window of a test device component of an assembly described herein, or an assembly prepared by a method described herein, and determining the presence or absence and/or amount of the analyte in the sample from the detectable signal.
  • the detectable signal often is an optically detectable signal, which can be detected by an instrument or by eye.
  • An optical signal can be detected with or without illumination ⁇ e.g., with or without dedicated illumination).
  • a signal detected optically is a signal emitted by nanoparticles ⁇ e.g., gold, latex, silver or carbon nanoparticles).
  • An optically detectable signal sometimes is emitted by a fluorescent probe excited by a light source ⁇ e.g., laser or light-emitting diode (LED) source) and a corresponding filter set to detect light emitted by the probe.
  • a light source e.g., laser or light-emitting diode (LED) source
  • R-phycoerythrin is detected after excitation by a laser at 515 nanometers (nm) and using a 10nm band-pass filter at 580nm.
  • An optical signal can be detected by a human eye ⁇ e.g., by eye of an operator (e.g., human operator)) and can be augmented ⁇ e.g., by a smartphone).
  • an optical signal can be detected using a reader device that includes one or more of a complementary metal oxide semiconductor (CMOS), charge-coupled device (CCD) and/or photodiode sensor, for example, where internal illumination is dependent on the detectable label being detected.
  • CMOS complementary metal oxide semiconductor
  • CCD charge-coupled device
  • photodiode sensor for example, where internal illumination is dependent on the detectable label being detected.
  • Presence, absence and/or amount of an analyte can be determined for a sample according to presence, absence and/or amount of a detectable signal detected through the window of a device assembly by any suitable process known in the art (e.g., consulting instructions included with or referred to by a kit, consulting a standard curve, consulting a look-up table).
  • Sample Collection The user collecting the sample grasps the Sample Collector ⁇ e.g., sample collection device 200) by the Sample Collector Handle ⁇ e.g., handle 201 ).
  • the Absorbent Collection Pad e.g., sample pad 230
  • the absorbent material may contain chemistry including but not limited to buffers, indicators, surfactants, secretion enhancers that dissolve and mix with the sample being collected.
  • the Sample Collector may take different forms including, but not limited to a swab stick, bladder, different shaped absorbent pads with various shapes and forms of handles, a cup, beaker, syringe, or pipette.
  • the Sample Collector may have a sufficiency indicator (either physical or chemical) imbedded in or in a pad in contact with the Absorbent Collection Pad to identify when adequate volume has been absorbed.
  • the sufficiency indicator can be visualized through a window within the sample collector, by a physical or mechanical conformational shift within the sample collection device. At this point the sample collector device 200 is ready for insertion in test device 100, as shown in FIG. 1A.
  • Sample Delivery - The user inserts the Absorbent Collection Pad ⁇ e.g., sample pad 230) into the Sample Collector Port e.g., proximal opening 120) of the Device Housing ⁇ e.g., test device housing 101 ).
  • the Sample Collector Handle ⁇ e.g., handle 201
  • One potential indicator for correct seating of the Sample Collector could be perceived through a physical change or an audible click generated by the Click Lock Feature ⁇ e.g., annular protrusion 218 of sample collection device 200) coming to rest in the locked position.
  • sample collector ⁇ e.g., sample collection device 200
  • the motion of insertion could be either sliding or screwing into the Sample Collection Port ⁇ e.g., proximal opening 120).
  • the Sample Port ⁇ e.g., proximal opening 120) leads to a Sample Process Cartridge ⁇ e.g., cartridge housing lumen 173d, 173e) which contains one or a series of Pads ⁇ e.g., cartridge housing pads 145 and 146), a Restriction Structure ⁇ e.g., terminal wall 175) and Sample Transport Ports ⁇ e.g., bores 177a, 177b).
  • the port(s) may consist of a single or multiple open zones for transfer of sample.
  • the compression action causes the Absorbent Collection Pad ⁇ e.g., sample pad 230) to compress at the Compression Zone ⁇ e.g., in sample expression zone 130) due to the presence of the Restriction Structure ⁇ e.g., terminal wall 175). This releases a metered volume of sample based on the dimensions of the Absorbent Collection Pad ⁇ e.g., sample pad 230), the Sample Process Cartridge Housing ⁇ e.g., cartridge housing 170) and the Restriction Structure ⁇ e.g., terminal wall 175).
  • the sample flows through the Filtration/Conjugate/Chemistry Pads ⁇ e.g., cartridge housing pads 145 and 146 in a filter housing unit that is discrete and separated from the sample collection pad), causing the sample to dissolve the chemistry associated with the pad(s).
  • FIG. 5 and FIG. 11 show two pads, but additional pads may be included to add support for the structural support of the other pads or to add additional chemistry or to enhance filtration.
  • the filter can be made of a porous pad, or other filtering material, substance or any other means by which a sample may be filtered.
  • the filter may contain materials or chemistry to separate portions of the sample and pre-conditioning materials including but not limited to surfactants, buffers, indicators, etc.
  • the resulting mixture of sample and chemistry/reagent passes through the Restriction Structure (e.g., terminal wall 175) which may act to further slow the transfer of the solution, thereby causing mixing and incubation of the sample.
  • the sample migrates through the Sample Transport Pad (e.g., transfer pad 165) toward the Lateral Flow Strip (e.g., test strip 185).
  • the sample may be retained for a period of time by the Sample Transport Pad (e.g., transfer pad 165) by the presence of a restriction zone by a compression of pad or due to chemistry/agents in the pad to retard the flow to act as a timing gate which allows for incubation of the chemistry or reagents.
  • Another iteration of this design may include an additional chemistry pad to introduce additional chemistry to the sample.
  • the design and structure of the Sample Transport Pad (e.g., transfer pad 165) may impart an additional metering aspect.
  • the portion of the Sample Transport Pad (e.g., transfer pad 165) proximal to the Lateral Flow Strip (e.g., test strip 185) may be in contact with or suspended above the Sample Application Zone (e.g., sample transfer zone 150) of the test strip.
  • the sample/reagent mixture comes in contact with and is absorbed into a Lateral Flow Strip (e.g., test strip 185) and migrates along the strip, interacting at the various reaction zones on the test strip.
  • An alternate mechanism may be integrated into the housing which holds the Sample Transport Pad (e.g., transfer pad 165) in place above the test strip and allows the sample to be transferred to the Sample Application Zone (e.g., sample transfer zone 150) only after a mechanical or chemical interaction to allow contact with the Sample Application Zone (e.g., sample transfer zone 150).
  • the mechanism controls the flow of the sample assuring the sample remains at the Sample Application Zone (e.g., sample transfer zone 150).
  • the strip housing may include an area surrounding the Sample Application (e.g., sample transfer zone 150) which acts as a reservoir to collect any excess sample that may build up at the application zone.
  • the Lateral Flow Test Strip (e.g., test strip 185) may contain various elements including, but not limited to nitrocellulose membrane, polyesters pads, glass fiber pads, absorbent pads, dried buffering chemicals, dried conjugated reporter molecule. At this point the device resembles assembly 300 illustrated in FIG. 14B.
  • the reaction zones will be interrogated either visually or by a reader system through the Results Viewing Window (e.g., window 110) to determine results.
  • a component described herein e.g., a sample collector component, test device component, test device housing component (/.e., anterior member, posterior member) and test device cartridge component (/.e., including a cartridge housing and terminal projection), may be manufactured by any suitable process.
  • suitable process include thermoforming, vacuum forming, pressure forming, plug-assist forming, reverse-draw thermoforming, matched die forming, extrusion, casting and injection molding.
  • the sample collection barrel and top housing can be combined into a single plastic part for cost reduction and manufacturability.
  • the sample collection device is a separate unit that is not molded to the top housing of the test device. In certain aspects as described and depicted herein, the sample collection device does not have a top housing.
  • certain portions of a component described herein are manufactured in one process and then one or more pads manufactured in a separate process are joined to the component.
  • handle and stem portions of a sample collection device component described herein e.g., component 200
  • a sample pad e.g., sample pad
  • a cartridge of a test device can be manufactured as a component by one process (e.g., cartridge 170 of test device 100) and then a transfer pad (e.g., transfer pad 165) and one or more optional cartridge housing pads (e.g., cartridge housing pads 145) each manufactured by a separate process can be joined to the cartridge.
  • a test device housing posterior member can be manufactured as a component by one process (e.g., posterior member 102) and a test strip (e.g., test strip 185) manufactured by a separate process can be joined to the posterior member.
  • a component described herein often is of a unitary construction and is molded from one material.
  • a unitary component often is molded from one material (e.g., a moldable polymer comprising polypropylene), and the entire component is of the same material.
  • a unitary component manufactured from a first material sometimes includes a pad constructed from the first material or a second material, where the first material (e.g., polypropylene) is different than the second material (e.g., polyethylene).
  • a component sometimes is of a multi-part construction, and two or more parts sometimes are molded separately (e.g., double-shot component).
  • a multi-part component sometimes includes a region manufactured from a first moldable material and another region manufactured from a second moldable material, where the second moldable material sometimes has a greater elasticity than the first moldable material.
  • a multi-part component for example, sometimes includes a region manufactured from a first moldable material and another region manufactured from a second moldable material, where the second moldable material contains an elastomer, and the first moldable material contains no elastomer, a different elastomer than the elastomer in the second moldable material or a lower content of the same elastomer as in the second moldable material.
  • a unitary component or a multi-part component sometimes includes no elastomer.
  • Non-limiting examples of polymers include polyethylene (PE), low density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene (PP), high impact polystyrene (HIPS), polyvinyl chloride (PVC), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), acrylonitrile butadiene styrene (ABS) and polycarbonate (PC).
  • PE polyethylene
  • LDPE low density polyethylene
  • HDPE high-density polyethylene
  • PP polypropylene
  • HIPS high impact polystyrene
  • PVC polyvinyl chloride
  • PET polyethylene terephthalate
  • APET amorphous polyethylene terephthalate
  • ABS acrylonitrile butadiene styrene
  • PC polycarbonate
  • One or more elements of a component can include, or can be manufactured from, a recyclable material and/or degradable material (e.g., a bio-degradable material), non-limiting examples of which are disclosed in International Application no. PCT/US2009/063762 filed on November 9, 2009 and published as WO 2010/054337 on May 14, 2010.
  • a recyclable material and/or degradable material e.g., a bio-degradable material
  • One or more elements of a component include an anti-microbial agent, non-limiting examples of which are disclosed in International Application no. PCT/US2009/047541 filed on June 16, 2009 and published as WO 2010/008737 on January 10, 2010 (e.g., antimicrobial metal (e.g., silver)).
  • a component described herein sometimes is manufactured by a method that includes: dispensing a molten polymer into a cavity of a mold configured to mold a component described herein, permitting the polymer in the cavity to cool, and releasing the formed component from the mold after cooling.
  • the mold sometimes includes a metal, and sometimes the mold is manufactured from a metal.
  • the metal sometimes includes one or more of aluminum, zinc, steel or a steel alloy.
  • Non-limiting examples of a polymer are provided herein.
  • the molding process is an injection molding process.
  • a mold for manufacturing a component described herein by a molding process which includes a body that forms exterior surfaces of the component and a member that forms interior surfaces of the component.
  • a mold sometimes includes one or more core components that form interior surfaces of the component (e.g., core pin component).
  • a component sometimes is manufactured by an injection molding process.
  • Injection molding is a manufacturing process for producing objects from thermoplastic (e.g., nylon, polypropylene, polyethylene, polystyrene and the like, for example) or thermosetting plastic (e.g., epoxy and phenolics, for example) materials.
  • a plastic material e.g., a polymer material
  • a pressure injection method often ensures the complete filling of the mold with the melted plastic. After the mold cools, mold portions are separated, and the molded object is ejected.
  • a plastic with higher flow and lower viscosity sometimes is selected for use in an injection molding process.
  • plastics with higher flow and lower viscosity include any suitable moldable material having one or more of the following properties: a melt flow rate (230 degrees Celsius at 2.16 kg) of about 30 to about 75 grams per 10 minutes using an ASTM D 1238 test method; a tensile strength at yield of about 3900 to about 5000 pounds per square inch using an ASTM D 638 test method; a tensile elongation at yield of about 7 to about 14% using an ASTM D 638 test method; a flexural modulus at 1% sectant of about 1 10,000 to about 240,000 pounds per square inch using an ASTM D 790 test method; a notched Izod impact strength (23 degrees Celsius) of about 0.4 to about 4.0 foot pounds per inch using an ASTM D 256 test method; and/or a heat deflection temperature (at 0.455 MPa) of about 160 degrees to about 250 degrees Fahrenheit using an ASTM D 648 test test method
  • Non-limiting examples of materials that can be used include polypropylene, polystyrene, polyethylene, acrylonitrile butadiene styrene, polycarbonate, the like, and mixtures thereof.
  • additional additives can be included in the plastic or mold to impart additional properties to the final product e.g., antimicrobial, degradable, anti-static properties).
  • a component can be injection molded as a unitary construct.
  • a mold often is configured to retain molten plastic in a geometry that yields the desired product upon cooling of the plastic.
  • Injection molds sometimes are made of two or more parts. Molds typically are designed so that the molded part reliably remains on the ejector side of the mold after the mold opens, after cooling. The molded part may fall freely away from the mold when ejected from ejector side of the mold. In some embodiments, an ejector pushes the molded part from the ejector side of the mold.
  • a method for manufacturing a sample collection device component described herein, or portion thereof that includes: injecting a liquid polymer into a mold; hardening the polymer in the mold, where the sample collection device or portion thereof is formed in the mold; and separating the sample collection device or portion thereof from the mold.
  • a portion of a sample collection device sometimes includes or consists of the handle and stem.
  • a method for manufacturing a sample collection device described herein that includes: providing a portion of the sample collection device described herein that includes the handle and stem, and providing the sample pad and joining the sample pad to the stem.
  • joining the sample pad to the stem can include inserting a portion of the sample pad into the interior of the stem.
  • the portion of the sample collection device that includes the handle and stem sometimes is manufactured by a manufacturing process described herein.
  • test device component described herein that includes: injecting a liquid polymer into a mold; hardening the polymer in the mold, wherein the test device component or portion thereof is formed in the mold; and separating the test device component or portion thereof from the mold.
  • a test device component sometimes is a test device housing anterior member, test device housing proximal member or cartridge containing a cartridge housing member, such as a filter in a filter housing cartridge or unit, and terminal projection member.
  • a method for manufacturing a test device component described herein includes: providing a test device housing posterior member and a test device housing anterior member; contacting a cartridge (e.g., a cartridge that includes a cartridge housing member and terminal projection) with the test device housing posterior member and/or the test device housing anterior member; and joining the test device posterior member and the test device anterior member, whereby the interior cartridge is contained within the test device housing interior.
  • the cartridge provided contains the transfer pad and optionally contains one or more cartridge housing pads.
  • the method includes providing a test strip and joining the test strip with the test device housing posterior member and/or the test device housing anterior member prior joining the test device posterior member and the test device anterior member.
  • the test device housing posterior member, the test device housing anterior member and/or the interior cartridge are manufactured according to a method described herein.
  • a mold for manufacturing a sample collection device described herein or portion thereof e.g., a component having the handle and stem.
  • a mold for manufacturing a test device component described herein e.g., test device housing anterior member, test device housing posterior member, cartridge including the cartridge housing and terminal extension
  • a sample collection device comprising: a handle, a stem in connection with the handle, and an absorbent sample pad in connection with the stem, wherein: the sample pad comprises a proximal surface, a distal surface and an exterior side surface between the proximal surface and the distal surface; at least a portion of the sample pad extends from the stem; and the sample collection device is configured to be inserted into a horizontally disposed test device at an orientation that is non-horizontal relative to the test device.
  • sample collection device of embodiment A1 or A1 ’ wherein the sample collection device is configured to be inserted into a horizontally disposed test device at an orientation that is vertical or at a right angle relative to the test device.
  • the sample collection device of embodiment A1 or A1 ’ wherein: the stem comprises an interior; and a portion of the sample pad is disposed within the stem interior.
  • A3 The sample collection device of any one of embodiments A1 , AT or A2, wherein a property of the sample pad changes upon contact with a fluid.
  • sample collection device of embodiment A3 wherein the sample pad comprises a colorimetric agent that shifts color upon contact with fluid.
  • A6 The sample collection device of embodiment A5, wherein the zone is a transverse band circumferentially disposed in or on the sample pad.
  • A9 The sample collection device of any one of embodiments A1 -A8, wherein the handle and/or the stem, or portion thereof, is transparent or translucent. A10. The sample collection device of any one of embodiments A1-A9, comprising a sealing member disposed on the stem.
  • sample collection device of embodiment A10 wherein the sample collection device comprises a first sealing member and a second sealing member each disposed on the stem.
  • A13 The sample collection device of any one of embodiments A1-A12, comprising a lock member disposed on the stem.
  • A16.1. The sample collection device of any one of embodiments A13-A15, wherein the lock members is a threaded member.
  • the handle comprises an interior surface spaced from an exterior surface of the stem; the interior surface spaced from the exterior surface of the stem comprises the threaded member.
  • the handle of the sample collection device is a tubular handle or comprises a tubular portion, comprising a handle proximal terminus, a handle distal terminus and a handle wall between the handle proximal terminus and the handle distal terminus;
  • the stem is a tubular stem or comprises a tubular portion, comprising a stem proximal terminus, a stem distal terminus, a stem wall between the stem proximal terminus and the stem distal terminus and a tubular stem interior;
  • the stem proximal terminus is in connection with the handle distal terminus;
  • the sample pad is a cylindrical pad or comprises a cylindrical portion.
  • A18 The sample collection device of embodiment A17, wherein: a first portion of the sample pad side is inserted within the tubular stem interior; and a second portion of the sample pad side extends from the stem distal terminus.
  • sample collection device of any one of embodiments A1-A18, wherein the sample pad absorbs a maximum fluid volume of about 0.1 milliliters to about 10 milliliters.
  • sample collection device of embodiment A20 wherein the sample pad has a density of about 0.01 grams/cubic centimeter (g/cc) to about 0.5 g/cc.
  • sample collection device of any one of embodiments A1-A21 , wherein the sample pad comprises (i) polyethylene, or (ii) polypropylene, or (iii) polyethylene and polypropylene.
  • sample collection device of any one of embodiments A1-A22, wherein the sample pad has an average pore size of about 5 micrometers to about 60 micrometers.
  • sample collection device of any one of embodiments A1-A23, wherein the sample pad comprises one or more reagents.
  • A25 The sample collection device of embodiment A24, wherein the one or more reagents are chosen from a buffering agent, detergent, protein, enzyme, antibody or antigen-binding fragment thereof, antigen, binding pair member, bulking agent, water-absorbing agent, saccharide, polysaccharide, nucleic acid amplification reagent, nucleic acid and aptamer.
  • the one or more reagents are chosen from a buffering agent, detergent, protein, enzyme, antibody or antigen-binding fragment thereof, antigen, binding pair member, bulking agent, water-absorbing agent, saccharide, polysaccharide, nucleic acid amplification reagent, nucleic acid and aptamer.
  • A26 The sample collection device of embodiment A24 or A25, wherein the one or more reagents are distributed in all or a portion of the sample pad.
  • A27 The sample collection device of any one of embodiments A1-A26, wherein the handle and stem independently comprise polypropylene, polyethylene, acrylonitrile butadiene styrene, or a combination of two or more of the foregoing.
  • a test device comprising: a hollow test device housing comprising a proximal terminus, a distal terminus, a sidewall between the proximal terminus and distal terminus, an interior, and a window disposed in the sidewall; a cartridge disposed within the test device housing, the cartridge comprising a filter housing unit, wherein the filter housing unit is discrete and configured such that it does not make direct contact with the sample pad when the test device is connected to a sample collection device in an assembly; a porous transfer pad disposed within the terminal projection member of the cartridge; and a lateral flow strip disposed in the test device housing adjacent to the transfer pad and distally disposed from the cartridge, the strip comprising a proximal surface, a distal surface, and an anterior surface and an opposite posterior surface each disposed between the proximal surface and the distal surface; wherein the window in the test device housing opposes a portion of the strip anterior side.
  • test device of embodiment B1 further comprising an excess sample reservoir located posterior to or behind the transfer pad.
  • a test device comprising: a hollow test device housing comprising a proximal terminus, a distal terminus, a sidewall between the proximal terminus and distal terminus, an interior, and a window disposed in the sidewall; a cartridge disposed within the test device housing, the cartridge comprising a filter housing unit; a porous transfer pad disposed within the terminal projection member of the cartridge; an excess sample reservoir located posterior to or behind the transfer pad; and a lateral flow strip disposed in the test device housing adjacent to the transfer pad and distally disposed from the cartridge, the strip comprising a proximal surface, a distal surface, and an anterior surface and an opposite posterior surface each disposed between the proximal surface and the distal surface; wherein the window in the test device housing opposes a portion of the strip anterior side.
  • test device of embodiment B1 wherein the filter housing unit is discrete and configured such that it does not make direct contact with the sample pad when the test device is connected to a sample collection device in an assembly.
  • test device of any one of embodiments B1 -B’ wherein a portion of the transfer pad is disposed within the cartridge terminal projection member and another portion of the transfer pad extends from the distal terminus of the cartridge terminal projection member.
  • the cartridge terminal wall comprises one or more bores.
  • the cartridge terminal projection member comprises an interior; and the one or more bores in the cartridge terminal wall each comprise a distally disposed aperture within the interior of the terminal projection member.
  • the transfer pad comprises an anterior side surface and an opposite posterior side surface each between the proximal surface and the distal surface of the pad; and the anterior side surface and the posterior side surface of the transfer pad each contact an interior surface of the cartridge terminal projection member.
  • the lateral flow strip comprises a lateral length and a perpendicular transverse width
  • the transfer pad comprises a lateral length and a perpendicular transverse width
  • the transfer pad width is substantially the same or the same as the lateral flow strip width.
  • test device of any one of embodiments B1 -B11 wherein the strip is retained in the test device housing by one or more strip retaining members disposed on an interior surface of the test device housing sidewall.
  • test device of embodiment B12 wherein the one or more strip retaining members extend from a posterior sidewall interior surface of the test device housing sidewall.
  • the strip retaining members comprise (i) one or more laterally disposed ribs, or (ii) one or more containment posts, or (iii) a combination of (i) and (ii).
  • test device of embodiment B14 wherein the posterior surface of the strip contacts a proximal edge of each of the one or more laterally disposed ribs of the test device housing.
  • test device of embodiment B14 or B15 wherein the strip comprises a laterally disposed edge on each side of the posterior surface and each laterally disposed edge of the strip contacts one or more containment posts of the test device housing.
  • test device housing comprises an anterior sidewall interior surface and an extension bar extending from the anterior sidewall interior surface comprising a posterior edge; and the posterior edge of the extension bar, or portion of the posterior edge, contacts a portion of the anterior surface of the transfer pad.
  • test device of embodiment B17 wherein the posterior edge of the extension bar, or portion of the posterior edge, contacts a portion of the anterior surface of the transfer pad opposite the anterior surface of the test strip.
  • test device of any one of embodiments B1 -B18 comprising: (i) a first extension wall disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall, or (ii) a second extension wall disposed on and extending from an anterior interior surface of the test device housing sidewall.
  • test device of embodiment B19 comprising (i) a first extension wall disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall and (ii) a second extension wall disposed on and extending from an anterior interior surface of the test device housing sidewall, wherein: the first extension wall comprises an anterior edge; the second extension wall comprises a posterior edge; and the anterior edge of the first extension wall is opposite to and spaced from the posterior edge of the second extension wall.
  • the terminal projection comprises an anterior wall and a posterior wall; the anterior edge of the first extension wall contacts an exterior surface of the terminal projection posterior wall; and the posterior edge of the second extension wall contacts an exterior surface of the terminal projection anterior wall.
  • test device of any one of embodiments B19-B21 comprising a third extension wall and a fourth extension wall each disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall, wherein: the third extension wall comprises an interior side that opposes an interior side of the fourth lateral extension wall; and the interior side of the third extension wall contacts a side of the first extension wall and the interior side of the fourth extension wall contacts an opposing side of the first extension wall.
  • the first extension wall comprises a major dimension that is transversely disposed; the third extension wall and the fourth extension wall each comprise a major dimension that is laterally disposed; and the first extension wall is perpendicular to each of the third extension wall and the fourth extension wall.
  • the cartridge terminal projection comprises a sidewall and an opposing sidewall between the anterior wall and the posterior wall; a portion of the interior side of the third extension wall contacts an exterior surface of the cartridge terminal projection sidewall; and a portion of the interior side of the fourth extension wall contacts an exterior surface of the cartridge terminal projection opposing sidewall.
  • test device housing comprises a proximal opening rim and an annular recessed surface distally disposed and adjacent to the proximal opening rim; and the proximal terminus of the cartridge housing contacts the annular recessed surface of the test device housing.
  • test device of embodiment B25 comprising an annular projection disposed on an interior surface of the test device housing sidewall and distally disposed from the proximal opening rim, the annular projection contacting a portion of an exterior surface of the cartridge housing sidewall.
  • the cartridge housing comprises an annular collar extending from an exterior surface of the cartridge housing sidewall;
  • the test device housing comprises a proximal opening rim and an annular recessed surface distally disposed and adjacent to the proximal opening rim; and the collar contacts the annular recessed surface and the rim of the test device housing.
  • test device of any one of embodiments B1 -B25.2, comprising post members each disposed on and extending from a posterior sidewall interior surface of the test device housing sidewall, wherein: a portion of one post member contacts a portion of the distal terminus of the terminal projection of the cartridge; and a portion of another post member contacts another portion of the distal terminus of the terminal projection of the cartridge.
  • test device of embodiment B26 wherein: the third extension wall and the fourth extension wall each comprise a distal side; one post member is connected to the distal side of the third extension wall; and another post member is connected to the distal side of the fourth extension wall.
  • the third extension wall and the fourth extension wall each comprise a proximal side; the proximal side of the third extension wall contacts a portion of the terminal wall of the cartridge housing; and the proximal side of the fourth extension wall contacts another portion of the terminal wall of the cartridge housing.
  • test device of any one of embodiments B1 -B28, wherein (i) the test device housing is a tube, or (ii) the cartridge housing is a tube, or (iii) the cartridge terminal projection is a tube, or (iv) a combination of two or more of (i) , (ii) and (iii).
  • test device of embodiment B29 wherein a first region of the test device housing is a tube comprising a circular or ovoid cross section.
  • test device B31 The test device of embodiment B30, wherein the first region of the test device housing is a cylindrical tube.
  • test device of embodiment B30 or B31 wherein the first region of the test device housing is co-terminal with the proximal terminus of the test device housing.
  • B33 The test device of any one of embodiments B30-B32, wherein a second region of the test device housing is a tube comprising a lateral planar cylindrical segment region.
  • test device of embodiment B33 wherein the second region is co-terminal with the distal terminus of the test device housing.
  • test device of embodiment B35 wherein the third region is disposed between the first region and the second region of the test device housing, and is co-extensive with the first region and the second region of the test device housing.
  • test device housing comprises a bore and the perimeter of the bore defines the window.
  • test device of embodiment B39 wherein the perimeter of the bore is ovoid or polygonal.
  • test device B41 The test device of any one of embodiments B35-B40, wherein the window is disposed in portion of the second region and an adjacent portion of the third region.
  • test device housing comprises a lock member counterpart to a lock member of a sample collection device configured to join with the test device.
  • the cartridge housing comprises an annular recessed edge adjacent to the proximal terminus; the test device housing comprises a proximal opening rim and an annular recessed surface adjacent to the proximal opening rim; and the annular groove is disposed between the annular recessed edge of the cartridge housing and the annular recessed surface of the test device housing.
  • test device of any one of embodiments B1 -B44 comprising a sealing member disposed on an interior surface of the test device housing and/or an interior surface of the cartridge housing.
  • test device of any one of embodiments B1 -B44 comprising one more porous cartridge pads disposed in an interior portion of the cartridge housing.
  • each of the one or more porous cartridge pads comprises a proximal surface, a distal surface and a side surface disposed between the proximal surface and the distal surface;
  • the terminal wall of the cartridge housing comprises an interior surface; and the distal surface of one of the cartridge pad contacts the interior surface of the cartridge housing terminal wall.
  • test device of embodiment B46 or B47 comprising two or more porous cartridge pads disposed in a stacked assembly.
  • test device of any one of embodiments B46-B50 wherein: the cartridge housing sidewall comprises an interior surface; and the side surface of each of the one or more cartridge pads contacts a portion of the interior surface of the cartridge housing sidewall.
  • test device of any one of embodiments B1 -B51 wherein the transfer pad comprises (i) polyethylene, or (ii) polypropylene, or (iii) polyethylene and polypropylene.
  • B53 The test device of any one of embodiments B1 -B52, wherein the transfer pad retains a maximum fluid volume of about 20 microliters to about 1 milliliter.
  • B54 The test device of embodiment B53, wherein the transfer pad retains a maximum fluid volume of about 50 microliters to about 500 microliters.
  • test device of embodiment B54 wherein the transfer pad retains a maximum fluid volume of about 100 microliters to about 300 microliters.
  • test device of any one of embodiments B1 -B56, wherein the test device housing and the cartridge independently comprise polypropylene, polyethylene, acrylonitrile butadiene styrene, or a combination of two or more of the foregoing.
  • test device housing is a two- piece housing comprising an anterior member and a posterior member.
  • B65 The test device of embodiment B64, wherein the one or more reagents are chosen from an analyte binding agent, buffering agent, cell lysis agent, detergent, protein, enzyme, antibody or antigen-binding fragment thereof, antigen, binding pair member, bulking agent, water-absorbing agent, saccharide, polysaccharide, nucleic acid amplification reagent, nucleic acid and aptamer.
  • B66 The test device of embodiment B64 or B65, wherein the one or more reagents are distributed in all or a portion of the transfer pad and/or the one or more cartridge pads.
  • test device of embodiment B66 wherein the transfer pad comprises a water-absorbing agent in region adjacent to the distal surface of the pad.
  • test device of embodiment B70 comprising a removable barrier between the portion of the transfer pad and the portion of the test strip adjacent to the transfer pad.
  • test device of embodiment B71 wherein: a portion of the transfer pad posterior surface is disposed opposite of a portion of the test strip anterior surface; and the removable barrier is disposed between the portion of the transfer pad posterior surface and the portion of the test strip anterior surface opposite to the portion of the transfer pad posterior surface.
  • test device of embodiment B71 wherein the removable barrier is a pull tab.
  • test device of any one of embodiments B70-B72 wherein a portion of the test device housing comprises a slot through which the removable barrier protrudes and extends from an exterior surface of the test device housing.
  • test device of embodiment B70 comprising a button disposed in the test device housing opposite of the portion of the transfer pad disposed adjacent to the portion of the test strip.
  • test device of embodiment B75 wherein: a portion of the transfer pad posterior surface is disposed opposite of a portion of the test strip anterior surface; and the button is disposed opposite of the portion of the transfer pad.
  • test device of any one of embodiments B75-B78, wherein the button is disposed on an anterior surface of the test device housing.
  • test device housing comprises an extension bar extending from an interior surface of the button and the test device housing; and a posterior surface of the extension bar is disposed opposite of the portion of the transfer pad disposed adjacent to the test strip.
  • test device housing comprises a catch
  • extension bar comprises a catch counterpart disposed adjacent to the catch in the test device housing.
  • a composition comprising: a sample collection device of any one of embodiments A1 -A27 and a test device of any one of embodiments B1-B81 , wherein the sample collection device is separated from the test device.
  • composition of embodiment C1 wherein the sample collection device is configured to join with the test device and the sample collection device is not joined and physically separated from the test device in the composition.
  • a kit comprising: a sample collection device of any one of embodiments A1-A27 and a test device of any one of embodiments B1 -B81 , wherein the sample collection device is separated from the test device. D2.
  • the kit of embodiment D1 comprising instructions for joining the sample collection device with the test device.
  • An assembly comprising: a sample collection device of any one of embodiments A1 -A27 and a test device of any one of embodiments B1-B81 , wherein the sample collection device is joined with the test device.
  • test device is distally disposed from the sample collection device handle; and the sample pad and at least a portion of the stem are contained within the test device.
  • a lateral length between the sample pad proximal terminus and the sample pad distal terminus in the sample collection device not joined to the test device is a first lateral distance
  • a lateral length between the sample pad proximal terminus and the sample pad distal terminus in the sample collection device joined to the test device is a second lateral distance
  • the first lateral distance is greater than the second lateral distance
  • E6 The assembly of embodiment E5, wherein the distal terminus of the sample pad contacts an interior surface of the cartridge or filter housing terminal wall or portion of the interior surface of the cartridge or filter housing terminal wall.
  • E7 The assembly of embodiment E5, wherein sample fluid from the distal terminus of the sample pad contacts a proximal surface of a cartridge or filter housing pad or portion of the proximal surface of the cartridge or filter housing pad.
  • E8.1 The assembly of any one of embodiments E1-E7, wherein: the sample collection device comprises a lock member disposed in the handle; the test device comprises a lock member counterpart disposed on an exterior surface of the test device; and the lock member of the sample collection device is engaged with the lock member counterpart of the test device.
  • E11 .2 The assembly of embodiment E11 .1 , wherein the threaded member of the sample collection device is disposed on an interior surface of the handle and the threaded member of the test device is disposed on a hollow shank extending from the cartridge and from the proximal terminus of the test device housing.
  • E12 The assembly of any one of embodiments E1 -E11 .2, wherein the sample collection device is sealing engaged with the test device.
  • a method for preparing an assembly containing a sample collection device and a test device comprising: joining a sample collection device of any one of embodiments A1 -A27 to a test device of any one of embodiments B1 -B81 , thereby forming the assembly of any one of embodiments E1- E17.
  • sample pad retains components in the sample fluid; and sample fluid expressed from the sample pad comprises an amount of the components less than the amount in the sample fluid applied to the sample pad.
  • F16 The method of embodiment F15, wherein the sample fluid transfers from the sample pad of the sample collection device through one or more bores disposed in the terminal wall of the cartridge or filter housing, to the transfer pad.
  • F17 The method of embodiment F15, wherein the sample fluid transfers from the sample pad of the sample collection device, through one or more cartridge or filter housing pads, then through one or more bores disposed in the terminal wall of the cartridge or filter housing, and then to the transfer pad.
  • F26 The method of any one of embodiments F23-F25, wherein: the portion of the transfer pad and the portion of the test strip are not in direct contact prior to, and after, joining the sample collection device to the test device; and the portion of the transfer pad and the portion of the test strip are placed in direct contact after the sample collection device is joined to the test device.
  • G1 A method for determining presence or absence and/or amount of an analyte in a sample, comprising: detecting through the window of the test device of an assembly of any one of embodiments E1 -E17, or an assembly prepared by a method of any one of embodiments F1 -F31 , a detectable signal from the lateral flow strip; and determining the presence or absence and/or amount of the analyte in the sample from the detectable signal.
  • a method for manufacturing a sample collection device of any one of embodiments A1-A27 comprising: injecting a liquid polymer into a mold; hardening the polymer in the mold, wherein the sample collection device or portion thereof is formed in the mold; separating the sample collection device or portion thereof from the mold.
  • a method for manufacturing a sample collection device of any one of embodiments A1 -A27 comprising: providing a portion of the sample collection device of any one of embodiments A1-A27 comprising the handle and stem; and providing the sample pad and joining the sample pad to the stem.
  • a method for manufacturing a test device of any one of embodiments B1 -B81 comprising: injecting a liquid polymer into a mold; hardening the polymer in the mold, wherein the test device or portion thereof is formed in the mold; separating the test device or portion thereof from the mold.
  • test device housing or portion thereof comprises the test device housing or portion thereof.
  • test device housing comprises a test device housing posterior member or a test device housing anterior member.
  • test device comprises the interior cartridge.
  • a method for manufacturing a test device of any one of embodiments B1 -B81 comprising: providing a test device housing posterior member and a test device housing anterior member; contacting the cartridge with the test device housing posterior member and/or the test device housing anterior member; and joining the test device posterior member and the test device anterior member, whereby the interior cartridge is contained within the test device housing interior.
  • L1 A mold for manufacturing a sample collection device of any one of embodiments A1 -A27 or portion thereof.
  • L2. A mold for manufacturing a test device of any one of embodiments B1 -B81 or portion thereof.

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Abstract

La technologie concerne en partie des dispositifs de test de diagnostic et concerne en partie des dispositifs de test qui comprennent une bande de test à flux latéral. La technologie concerne en partie un système de dispositif de test qui incorpore une collecte d'échantillons, une distribution, une mesure, un traitement, une incubation, une régulation de flux et une analyse d'un échantillon d'intérêt dans un seul ensemble. La technologie concerne en partie un ensemble qui comprend un dispositif de collecte d'échantillons et un dispositif de test, le dispositif de collecte d'échantillons étant relié à un dispositif de test orienté horizontalement dans une orientation non horizontale par rapport au dispositif de test orienté horizontalement.
PCT/US2024/041754 2023-08-11 2024-08-09 Dispositif de collecte et de test d'échantillon avec éléments intégrés et distincts Pending WO2025038467A2 (fr)

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USD396145S (en) * 1996-12-23 1998-07-21 Gillette Canada Inc. Toothbrush
US7879293B2 (en) * 2001-09-28 2011-02-01 Orasure Technologies, Inc. Sample collector and test device
US20050059165A9 (en) * 2002-01-31 2005-03-17 Davis James O. Universal sample collection and testing system
US20040184954A1 (en) * 2003-03-18 2004-09-23 Huiyan Guo Lateral flow immunoassay devices for testing saliva and other liquid samples and methods of use of same
GB0625309D0 (en) * 2006-12-19 2007-01-24 Inverness Medical Switzerland Device
GB2468683A (en) * 2009-03-18 2010-09-22 Cozart Bioscience Ltd Oral fluid collection device
CN103827324B (zh) * 2011-07-27 2021-01-12 Nexus Dx股份有限公司 用于检测分析物的装置和方法
US20220249073A1 (en) * 2021-02-08 2022-08-11 Orthogonal Diagnostics, Inc. Integrated sample collection and test device
CN115015541A (zh) * 2021-03-05 2022-09-06 全球诊断系统受益有限责任公司 带流体贮存器的诊断装置及相关方法和试剂盒

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