Sample collection and disposal swabs

Abstract

Provided herein are devices, kits, systems, and methods for collecting samples for analysis and for the safe disposal of sample collection devices after their use. The devices, kits, systems, and methods are utilized by users for the disposal of biohazardous materials in environments that may not have specialized biohazard disposal systems, such as laboratories, hospitals, and clinics.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 021,526, filed May 7, 2020, and U.S. Provisional Patent Application No. 63 / 038,307, filed June 12, 2020, each of which is incorporated by reference herein in its entirety.

[0002] Field Provided herein are devices, kits, systems, and methods for collecting biological samples for analysis and for the safe disposal of sample collection devices after their use. The devices, kits, systems, and methods are utilized, for example, to provide biological samples for testing and for disposal of biohazard or other hazardous materials by users in laboratories, hospitals, and clinics, environments that may not have specialized biohazard disposal systems. [Background technology]

[0003] Biological samples, such as saliva, mucus, and blood, are often tested for the presence of pathogens using a sample collection device for collecting the biological sample and an analytical device for testing the biological sample. A user collecting the biological sample using the sample collection device risks coming into contact with the biological sample during collection, thus exposing the user to a biohazard risk. Furthermore, after transferring the biological sample to the analytical device for testing, the sample collection device may retain a portion of the biological sample, thus the used sample collection device may also pose a biohazard risk. Techniques are needed for handling biological samples and for disposing of sample collection devices containing biological samples that may pose such biohazard risks. Summary of the Invention [Problem to be solved by the invention]

[0004] Provided herein are devices, kits, systems, and methods for collecting biological samples for analysis and for the safe disposal of sample collection devices after their use. The devices, kits, systems, and methods are utilized, for example, to provide biological samples for testing and for the disposal of biohazardous materials by users in laboratories, hospitals, and clinics, environments that may not have specialized biohazard disposal systems. Accordingly, the technology provided herein reduces the risk of biohazard to users during the sample preparation process for analytical testing.

[0005] For example, the outbreak of the COVID-19 pandemic has created a need for substantial testing outside of traditional laboratory and hospital settings. Some tests, such as lateral flow-based immunoassays, can be easily performed by unskilled users at home, in clinics, or in non-traditional settings. Embodiments of the devices, kits, systems, and methods provided herein offer new ways to minimize the risk of exposure of users, communities, healthcare workers, and laboratory personnel to dangerous or biohazardous agents, such as SARS-CoV-2, during sample preparation and testing. [Means for solving the problem]

[0006] In some embodiments, the present technology provides a sample collection device comprising an extraction tube body including an upper end, a middle section, and a lower end. In some embodiments, the upper end is configured to receive an upper cap, the lower end is configured to receive a lower cap, and the lower end includes a dropper feature. Thus, in some embodiments, the sample collection device includes an extraction tube body, an upper cap, and a lower cap, and the extraction tube body includes a lower end that includes a dropper feature. In some embodiments, the extraction tube body receives a swab device. In some embodiments, the swab device includes a swab handle including a proximal end and a distal end, and the swab device includes a swab end at the distal end of the swab handle. In some embodiments, the swab device has a length that is longer than the sum of the length of the middle section and the length of the upper end.

[0007] In some embodiments, the swab device includes a breakable joint. In some embodiments, the extraction tube body includes a separation component. In some embodiments, the separation component is configured to interact with the breakable joint (e.g., facilitate breaking of the swab device (e.g., swab handle) at the breakable joint). In some embodiments, the extraction tube body includes a fill line. In some embodiments, the fill line indicates a volume of approximately 300 μL. In some embodiments, the swab device is flexible. In some embodiments, the swab device can be bent and / or compressed to fit snugly inside the extraction tube body. In some embodiments, the extraction tube body includes an upper cap sealing the upper end and a lower cap sealing the lower end, and at least a portion of the swab device is sealed inside the extraction tube body. In some embodiments, the extraction tube body includes an upper cap sealing the upper end, and the dropper feature is exposed. In some embodiments, the dropper feature outputs a droplet of approximately 50 μL. In some embodiments, the extraction tube body is made from polyethylene (eg, high density polyethylene).

[0008] In some embodiments, the central portion has a length of approximately 80.1 mm. In some embodiments, the swab device and / or swab handle has a length greater than approximately 80.1 mm. In some embodiments, the swab device and / or swab handle has a length of approximately 71-100 mm. In some embodiments, the upper end of the extraction tube body has a length of approximately 7.8 mm or approximately 9.6 mm. In some embodiments, the extraction tube body has an outer diameter of approximately 10.5 mm. In some embodiments, the extraction tube body has an inner diameter of approximately 9 mm. In some embodiments, the lower end of the extraction tube body has a length of approximately 13 mm. In some embodiments, the dropper feature has an outer diameter of approximately 2.5 mm. In some embodiments, the dropper feature has an inner diameter of approximately 1.6 mm.

[0009] In some embodiments, the present technology provides a kit comprising: a) a swab device comprising a swab tip and a swab handle; b) a sample collection device comprising an extraction tube body comprising a dropper feature; and c) a buffer solution. In some embodiments, the sample collection device comprises an upper cap and a lower cap. In some embodiments, the extraction tube body comprises an upper end configured to receive the upper cap, and the extraction tube body comprises a lower end configured to receive the lower cap. In some embodiments, the swab device comprises a breakable joint. In some embodiments, the swab handle of the swab device comprises a breakable joint. In some embodiments, the swab handle of the swab device comprises a proximal end and a distal end, the swab handle comprises a swab tip at the distal end, and the swab handle comprises a breakable joint between the proximal end of the swab handle and the distal end of the swab handle. In some embodiments, the breakable joint is approximately 5-9 cm from the swab tip.

[0010] In some embodiments, the present technology provides a kit comprising: a) a swab device including a swab handle having a proximal end and a distal end, a swab end at the distal end of the swab handle, and a breakable joint between the swab end and the proximal end of the swab handle; b) a sample collection device including: i) an extraction tube body including a dropper feature, ii) an upper cap, and iii) a lower cap; and c) a buffer solution (e.g., provided in a buffer solution bottle). In some embodiments, the kit further comprises an analytical assay device, e.g., an analytical assay device configured to detect hazardous (e.g., biohazardous) substances (e.g., pathogens). See, e.g., International Patent Application No. PCT / US21 / 026183, incorporated herein by reference. In some embodiments, the kit further comprises a biohazard waste container.

[0011] In some embodiments of the kit, the extraction tube body receives the swab device. In some embodiments of the kit, the swab device includes a breakable joint. In some embodiments of the kit, the extraction tube body includes a separation component. In some embodiments of the kit, the separation component is configured to break the swab device. In some embodiments of the kit, the swab device includes a breakable joint, and the separation component is configured to interact with the breakable joint. In some embodiments of the kit, the extraction tube body includes a fill line. In some embodiments of the kit, the fill line indicates a volume of approximately 300 μL. In some embodiments of the kit, the swab device is flexible. In some embodiments of the kit, the swab handle is flexible. In some embodiments of the kit, the swab device can be bent or compressed to fit snugly inside the extraction tube body. In some embodiments of the kit, the dropper feature outputs a droplet of approximately 50 μL. In some embodiments of the kit, the sample collection device is made of polyethylene. In some embodiments of the kit, the sample collection device is made from high density polyethylene.

[0012] In some embodiments, the present technology provides a system comprising: a) a swab device comprising a swab tip and a swab handle; b) a sample collection device comprising an extraction tube body comprising a dropper feature; and c) a buffer solution. In some embodiments, the sample collection device comprises an upper cap and a lower cap. In some embodiments, the extraction tube body comprises an upper end configured to receive the upper cap, and the extraction tube body comprises a lower end configured to receive the lower cap. In some embodiments, the swab device comprises a breakable joint. In some embodiments, the swab handle of the swab device comprises a breakable joint. In some embodiments, the swab handle of the swab device comprises a proximal end and a distal end, the swab handle comprises a swab tip at the distal end, and the swab handle comprises a breakable joint between the proximal end of the swab handle and the distal end of the swab handle. In some embodiments, the breakable joint is approximately 5-9 cm from the swab tip.

[0013] In some embodiments, the present technology provides a system comprising: a) a swab device including a swab handle having a proximal end and a distal end, a swab end at the distal end of the swab handle, and a breakable joint between the swab end and the proximal end of the swab handle; b) a sample collection device including: i) an extraction tube body including a dropper feature, ii) an upper cap, and iii) a lower cap; and c) a buffer solution (e.g., provided in a buffer solution bottle). In some embodiments, the system further comprises an analytical assay device, e.g., an analytical assay device configured to detect hazardous (e.g., biohazardous) substances (e.g., pathogens). See, e.g., International Patent Application No. PCT / US21 / 026183, incorporated herein by reference. In some embodiments, the system further comprises a biohazard waste container.

[0014] In some embodiments of the system, an extraction tube body receives the swab device. In some embodiments of the system, the swab device includes a breakable joint. In some embodiments of the system, the extraction tube body includes a separation component. In some embodiments of the system, the separation component is configured to break the swab device. In some embodiments of the system, the swab device includes a breakable joint, and the separation component is configured to interact with the breakable joint. In some embodiments of the system, the extraction tube body includes a fill line. In some embodiments of the system, the fill line indicates a volume of approximately 300 μL. In some embodiments of the system, the swab device is flexible. In some embodiments of the system, the swab handle is flexible. In some embodiments of the system, the swab device can be bent or compressed to fit snugly inside the extraction tube body. In some embodiments of the system, the dropper feature outputs a droplet of approximately 50 μL. In some embodiments of the system, the sample collection device is made from polyethylene. In some embodiments of the system, the sample collection device is made from high-density polyethylene.

[0015] In some embodiments, the technology relates to a method. For example, in some embodiments, the method includes: a) providing a kit as described herein; b) adding a buffer solution to an extraction tube body; c) contacting a swab device (e.g., the swab end) with a sample; d) inserting the swab device into the extraction tube body with the swab handle (e.g., the proximal end of the swab handle) extending over the top end of the extraction tube body and positioning the swab end in the buffer solution; e) separating the swab end from at least a portion of the swab handle and / or pushing the swab device into the extraction tube body; f) securing an upper cap onto the top end of the extraction tube body; g) removing a lower cap from the bottom end of the extraction tube body; and h) dispensing a buffer solution containing a sample from a dropper feature. In some embodiments, the method further includes providing an analytical assay device and performing an analytical assay on the dispensed buffer solution containing the sample by applying the dispensed buffer solution containing the sample to the analytical assay device. In some embodiments, the method includes placing the extraction tube body including the swab end and / or the analytical assay device into a biohazard waste container. In some embodiments, the method includes contacting a swab device with a sample, the swab device including a swab end and a swab handle, inserting the swab device into the extraction tube body with the swab handle extending above the top end of the extraction tube body, and releasing the swab end from at least a portion of the swab handle by contacting it with the exterior of the extraction tube body. In some embodiments, the method further includes securing a top cap onto the top end of the extraction tube body, removing a bottom cap from the extraction tube body, and dispensing a buffer solution including the sample from the dropper feature.

[0016] These and other features, aspects, and advantages of the present technology will become better understood with regard to the following drawings. [Brief explanation of the drawings]

[0017] [Figures 1A-1K]1 illustrates an exemplary swab device and extraction tube body described herein, as well as an exemplary workflow (e.g., method embodiment) for employing the swab device and extraction tube body described herein. [Figure 1A] A sample collection device (100) is shown, comprising an extraction tube body (110) including a fill line (111), a top cap (120), and a bottom cap (130); a swab device (200) including a swab handle (220) including a swab tip (210) and a breakable joint (230); and a dropper bottle (300) including a dropper bottle cap (320) and a dropper bottle body (310) containing a buffer solution. The distal end (222) of the swab handle (220) comprises the swab tip (210), and the proximal end (221) of the swab handle (220) is opposite the swab tip (210). [Figure 1B] 1 illustrates how buffer solution is added to the extraction tube after the top cap is removed from the extraction tube. The dropper bottle cap (320) is removed from the dropper bottle body (310) and buffer solution (330) is dispensed (e.g., as droplets) into the extraction tube body (110). The extraction tube body (110) includes a fill line (111) indicating approximately 300 μL from the bottom of the extraction tube body (110). The fill line (111) provides a reference for the user to observe (900) that the bottom of the extraction tube body (110) has filled with a sufficient amount of buffer solution (330) to extract at least a portion of the sample from the swab device (e.g., the swab end of the swab device) upon placement into the extraction tube body (110). As shown in FIG. 1B, a buffer solution (330) is added to the extraction tube body (110) before the sample is added to the extraction tube body (110), thus eliminating and / or minimizing the risk of pathogen splashing. [Figure 1C]1C depicts a swab device inserted into a rotating extraction tube containing a buffer solution (e.g., after it has been used to collect a sample from a subject (e.g., a subject with COVID-19). As shown in FIG. 1C, embodiments provide for a swab device (200) to be placed within an extraction tube body (110) with the swab end (210) in the buffer solution (330), and the swab being rotated (e.g., by rotating (800) the swab handle (220)) to deliver at least a portion of the sample on the swab end (210) into the buffer solution (330). [Figure 1D] 1D shows the swab end within the extraction tube body after the swab device has been cut or broken at the breakable joint (e.g., to shorten the swab device sufficiently so that it will be sealed within the extraction tube body when the top cap is placed on the extraction tube body). As shown in FIG. 1D, in some embodiments, the swab device (200) includes a breakable joint (230), and the swab handle (220) of the swab device (200) is broken at the breakable joint (230). As shown in FIG. 1D, the swab end (210) remains in the buffer solution (330) at the bottom of the extraction tube body (110), which eliminates and / or minimizes the risk of pathogen splashing and spreading. [Figure 1E] A top cap (120) is shown being added to the extraction tube body (110) to seal the swab end (210) and a portion of the swab handle (220) within the extraction tube body (110). As shown in Figure 1E, adding the top cap (120) to the extraction tube body (110) seals the swab end (210) within the extraction tube body (110), thus minimizing and / or eliminating the risk of exposing the user or other individuals to pathogens. [Figure 1F] The extraction tube body (110) is shown with a swab tip (210) and a portion of the swab handle (220) sealed within the extraction tube body (110) (eg, by a top cap (120)). [Figure 1G-1H]Shown is a swab device (200) including a swab tip (210) and a compressed and / or bent swab handle (220) sealed (e.g., by top cap (120)) within extraction tube body (110). Swab handle (220) may be unbreakable or may be part of the swab handle after it has been cut or broken at a breakable joint. [Figure 1I] The bottom cap (130) is shown removed from the extraction tube body (110) to reveal the dropper feature (103). [Figure 1J] 1 shows a bottom cap removed from an extraction tube body 110 to reveal a dropper feature 103, e.g., a dropper feature 103 configured to dispense a droplet of sample 500 (e.g., in buffer solution 330) onto a sample well of an analytical assay device 600. In some embodiments, the extraction tube body 110 is flexible, and squeezing 700 the extraction tube body increases pressure within the extraction tube body 110, forcing the sample 500 (e.g., in buffer solution 330) out of the dropper feature 103. [Figure 1K]Two components are shown: 1) an extraction tube body (110) including at least a portion of a swab end (210) and a swab handle (220), and 2) an analytical assay device (600) (e.g., in a biohazard-compliant bag). As shown in FIG. 1J, a bottom cap (130) is placed on (e.g., connected to) the extraction tube body (110) including at least a portion of the swab end (210) and a swab handle (220). As a result, the swab device (200) is sealed within the sample collection device (100). Specifically, at least a portion of the swab end (210) and a swab handle (220) are enclosed by the top cap (120) and the bottom cap (130). and sealed within the extraction tube body (110). The sample collection device (100) (e.g., the extraction tube body (110), the top cap (120), and the bottom cap (130)) and the swab device (200) (e.g., the swab tip (210) and at least a portion of the swab handle (220)) are disposed of in a biohazard-compliant bag (999). The analytical assay device (600) can be disposed of in the biohazard-compliant bag (999). As a result of this exemplary arrangement, only two components—1) the sample collection device (100) including the swab device (200), and 2) the analytical assay device (600)—are contaminated and discarded using biohazard disposal procedures. [Figure 2A] 1 is a diagram of an exemplary extraction tube body (110). The extraction tube body (110) includes an upper end (101), a middle section (107), and a lower end (102). The upper end (101) includes an upper thread (104). The lower end (102) includes a lower thread (108) and a dropper feature (103). In some embodiments, the extraction tube body (110) further includes an optional lip (105) and a support flange (106). In some embodiments, the extraction tube body (110) includes a fill line (111), e.g., indicating a volume of approximately and / or at least 300 μL. [Figure 2B]1 is a diagram of an exemplary extraction tube body (110). The extraction tube body (110) includes an upper end (101), a middle section (107), and a lower end (102). The lower end (102) includes a dropper feature (103). In some embodiments, the extraction tube body (110) further includes an optional lip (105) and a support flange (106). [Figure 3A] 1 is a diagram of a top cap (120) shown in top view. In some embodiments, the top cap (120) comprises a plurality of ridges (121) around its periphery. [Figure 3B] 1 is a diagram of a top cap (120) shown in side view. In some embodiments, the top cap (120) comprises a plurality of ridges (121) around its periphery. [Figure 3C] 1 is a diagram of a top cap (120) shown in perspective view. In some embodiments, the top cap (120) includes a plurality of ridges (121) around its periphery. In some embodiments, the top cap (120) includes threads (122) for engaging with, for example, the top threads of the extraction tube body. [Figure 4A] 1 is a diagram of a bottom cap (130) shown in top view. In some embodiments, the bottom cap (130) includes a plurality of ridges (131) around its periphery. [Figure 4B] 1 is a diagram of a bottom cap (130) shown in side view. In some embodiments, the bottom cap (130) includes a plurality of ridges (131) around its periphery. In some embodiments, the bottom cap (130) includes threads (132) for engaging with, for example, the bottom threads of the extraction tube body. [Figure 5A] FIG. 2 is a diagram of one embodiment of a swab device (200) comprising an extraction tube body (110) including a separation component (140) and a swab handle (220) including a swab tip (210) and a breakable joint (230). [Figure 5B]A diagram showing the use of the separation component (140) of the extraction tube body (110) to break the swab device (200) at the breakable joint (230) by pinching (700) the extraction tube body (110) to cause the separation component (140) to interact with the breakable joint (230) to break the swab handle (220) at the breakable joint (230). DETAILED DESCRIPTION OF THE INVENTION

[0018] It should be understood that the figures are not necessarily to scale, and that objects in the figures are not necessarily to scale relative to each other. The figures are representations intended to bring clarity and understanding to various embodiments of the devices, systems, and methods disclosed herein. Wherever possible, the same reference numbers will be used throughout the figures to refer to the same or like parts. Moreover, it will be understood that the figures are not intended to limit the scope of the present teachings in any way.

[0019] Provided herein are devices, kits, systems, and methods for collecting biological samples for analysis and for the safe disposal of sample collection devices after their use. The devices, kits, systems, and methods are utilized, for example, for providing biological samples for testing and for the disposal of biohazardous materials by users in environments that may not have specialized biohazard disposal systems, such as laboratories, hospitals, and clinics.

[0020] In this detailed description of various embodiments, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the disclosed embodiments. However, those skilled in the art will understand that these various embodiments may be practiced without these specific details. In other instances, structures and devices are shown in block diagram form. Furthermore, those skilled in the art will readily understand that the specific order in which the methods are presented and performed is exemplary; it is contemplated that the order can be changed and still remain within the spirit and scope of the various embodiments disclosed herein.

[0021] All literature and similar materials cited within this application, including but not limited to patents, patent applications, articles, books, papers, and Internet web pages, are expressly incorporated by reference in their entirety for any purpose. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the various embodiments described herein belong. In the event that a definition of a term within an incorporated reference appears to differ from the definition provided in the present teachings, the definition provided in the present teachings shall control. The section headings used herein are for organizational purposes only and should not be construed to limit the subject matter described in any way.

[0022] To facilitate understanding of the present technology, several terms and phrases are defined below. Additional definitions are set forth throughout the detailed description.

[0023] Throughout the specification and claims, the following terms take the meanings expressly associated therewith herein, unless the context clearly dictates otherwise. The phrase "in one embodiment" does not necessarily refer to the same embodiment herein, although it may. Additionally, the phrase "in another embodiment" does not necessarily refer to different embodiments herein, although it may. Thus, as described below, various embodiments of the invention can be readily combined without departing from the scope or spirit of the invention.

[0024] Additionally, as used herein, the term "or" is an inclusive "OR" operator and is equivalent to the term "and / or" unless the context clearly dictates otherwise. The term "based on" is not exclusive and allows for based on additional unexplained factors unless the context clearly dictates otherwise. Furthermore, throughout this specification, "a," "an," and "the" include plural references. The meaning of "in" includes "in" and "on."

[0025] As used herein, the terms "about," "approximately," "substantially," and "significantly" will be understood by those of ordinary skill in the art and will vary to some extent depending on the context in which they are used. If there are uses of these terms that are not clear to persons of ordinary skill in the art given the context in which they are used, "about" and "approximately" will mean ±10% or less of the particular term, and "substantially" and "significantly" will mean more than ±10% of the particular term.

[0026] As used herein, disclosure of ranges includes disclosure of all values ​​within the entire range and further divided ranges, including the endpoints and subranges given for the range.

[0027] As used herein, the suffix "-free" refers to an embodiment of a technology that excludes the root feature of the word to which it is attached. That is, "-free X" as used herein means "without X," where X is the technology feature excluded in the "-free X" technology. For example, a "calcium-free" composition does not contain calcium, a "mixing-free" method does not include a mixing step, etc.

[0028] Terms such as "first," "second," "third," and the like may be used herein to describe various steps, elements, compositions, components, regions, layers, and / or sections; however, these steps, elements, compositions, components, regions, layers, and / or sections should not be limited by these terms unless otherwise indicated. These terms are used to distinguish one step, element, composition, component, region, layer, and / or section from another step, element, composition, component, region, layer, and / or section. Terms such as "first," "second," and other numerical terms, when used herein, do not imply an order or sequence unless clearly indicated by context. Thus, a first step, element, composition, component, region, layer, or section described herein may be referred to as a second step, element, composition, component, region, layer, or section without departing from the art.

[0029] As used herein, the terms "presence" or "absence" (or, alternatively, "present" or "lacking") are used in a relative sense to describe the amount or level of a particular entity (e.g., an analyte). For example, when an analyte is said to be "present" in a test sample, it means that the level or amount of the analyte is above a predefined threshold; conversely, when an analyte is said to be "lacking" in a test sample, it means that the level or amount of the analyte is below a predefined threshold. The predefined threshold may be a threshold for detectability associated with the particular test used to detect the analyte or any other threshold. When an analyte is "detected" in a sample, it is "present" in the sample; when the analyte is "not detected," it is "lacking" in the sample. Furthermore, a sample in which an analyte is "detected" or "present" in is a "positive" sample for that analyte. A sample in which the analyte is "not detected" or in which the analyte is "lacking" is a sample that is "negative" for that analyte.

[0030] As used herein, a "system" refers to multiple real and / or abstract components that operate together for a common purpose. In some embodiments, a "system" is an integrated collection of hardware and / or software components. In some embodiments, each component of a system interacts with and / or is associated with one or more other components. In some embodiments, a system refers to a combination of components and software for controlling and directing a method.

[0031] As used herein, the term "configured" refers to a component, module, system, subsystem, etc. that is constructed to perform an indicated function.

[0032] As used herein, the term "pathogen" refers to an organism, including microorganisms, that causes disease in another organism (e.g., animals (e.g., humans) and plants) by directly infecting the other organism or by producing an agent (e.g., bacteria that produce pathogenic toxins and the like) that causes disease in another organism. As used herein, pathogens include, but are not limited to, prokaryotes and eukaryotes (e.g., bacteria, archaea, and / or any member of eukaryotes); thus, the term includes bacteria, eukaryotes, archaea, protozoa, fungi, nematodes, viroids, and viruses, or any combination thereof; a pathogen, either alone or in concert with another pathogen, can induce disease in vertebrates, including, but not limited to, mammals, including, but not limited to, humans. As used herein, the term "pathogen" also encompasses microorganisms that may not normally be pathogenic in an unimmune-compromised host. Specific non-limiting examples of viral pathogens include herpes simplex virus (HSV) 1, HSV2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), human herpesvirus (HHV) 6, HHV7, HHV8, varicella-zoster virus (VZV), hepatitis C, hepatitis B, adenovirus, Eastern equine encephalitis virus (EEEV), West Nile virus (WNE), JC virus (JCV), BK virus (BKV), MERS, SARS, SARS coronavirus 2, influenza virus, Zika virus, chikungunya virus, aura virus, bebar virus, and kabasovirus. These include Rus, Dengue, Fort Morgan, Getah, Kiziraga, Mayoaro, Middelburg, Mucambo, Nudum, Pixuna, Tonate, Trinity, Una, Western equine encephalomyelitis, Wataroa, Sindbis, Semliki Forest, Venezuelan equine encephalomyelitis, Ross River, HIV-1, HIV-2, HTLV-1, HTLV-2, HTLV-3, and HTLV-4.See, for example, Strauss and Strauss, Microbiol. Rev., 58:491-562 (1994), incorporated herein by reference.

[0033] As used herein, the term "microorganism" includes prokaryotic and eukaryotic microbial species from the domains of Archaea, Bacteria, and Eukarya, the latter including yeast and filamentous fungi, protozoa, algae, or higher protists. The terms "microbial cell" and "microbe" are used interchangeably with the term "microorganism."

[0034] The terms "bacteria" and "bacteria" refer to prokaryotes of the domain Bacteria in the three-domain system (see, e.g., Woese CR et al., Proc Natl Acad Sci USA 1990, 87:4576-79). The term is intended to encompass all microorganisms considered to be bacteria, including Mycobacteria, Mycoplasma, Chlamydia, Actinomyces, Streptomyces, and Rickettsia. All forms of bacteria are included within this definition, including cocci, bacilli, spirochetes, spheroplasts, protoplasts, etc. In some embodiments, bacteria can cause disease and product degradation or damage. Consequently, "bacteria," or "eubacteria," refers to the domain of prokaryotes. Bacteria comprise at least 11 distinct groups: (1) Gram-positive (Gram+) bacteria, which have two major subdivisions: (i) the high G+C group (Actinomycetes, Mycobacteria, Micrococcus, etc.) and (ii) the low G+C group (Bacillus, Clostridium, Lactobacillus, Staphylococcus, Streptococcus, Mycoplasma), (2) Proteobacteria, e.g., purple photosynthetic + non-photosynthetic Gram-negative bacteria (including the most "common" Gram-negative bacteria), (3) Cyanobacteria, e.g., oxygenic photosynthetic organisms, (4) Spirochetes and related species, (5) Planctomycetes, (6) Bacteroids, Flavobacteria, (7) Chlamydiae, (8) Green sulfur bacteria, (9) Green non-sulfur bacteria (also anaerobic photosynthetic organisms), (10) Radioresistant Micrococcus and related species, and (11) Thermotoga and Thermosipho thermophilic bacteria.

[0035] "Gram-negative bacteria" include cocci, nonenteric rod, and enteric rod bacteria. Genera of Gram-negative bacteria include, for example, Neisseria, Spirillum, Pasteurella, Brucella, Yersinia, Francisella, Haemophilus, Bordetella, Escherichia coli, Salmonella, Shigella, Klebsiella, Proteus, Vibrio, Pseudomonas, Bacteroides, Acetobacter, Aerobacter, Agrobacterium, Azotobacter, Spirillum, Serratia, Vibrio, Rhizobium, Chlamydia, Rickettsia, Treponema, and Fusobacterium.

[0036] "Gram-positive bacteria" include cocci, nonsporulating rods, and sporulating rods. Genera of Gram-positive bacteria include, for example, Actinomyces, Bacillus, Clostridium, Corynebacterium, Erysipelothrix, Lactobacillus, Listeria, Mycobacterium, Myxococcus, Nocardia, Staphylococcus, Streptococcus, and Streptomyces.

[0037] As used herein, the term "sample" refers to a substance to be tested for the presence or amount of an analyte, e.g., a pathogen or a part or component thereof. Preferably, the sample is a fluid sample, preferably a liquid sample, and most preferably a nasopharyngeal sample collected by the swab device described herein. For example, the sample may be a bodily fluid such as blood, serum, plasma, ocular fluid, urine, mucus, semen, nasopharyngeal swab fluid, throat swab, tears, sweat, or saliva. Viscous liquid, semi-solid, or solid samples may be used to create solutions, eluates, suspensions, or extracts that may be samples. For example, a throat, nose (e.g., a nasopharyngeal swab sample), or genital swab may be suspended in a solution (e.g., a buffer solution) to create a sample.

[0038] As used herein, the term "coupled" refers to two or more components that are secured together by any suitable means (e.g., by engaged threads). Consequently, in some embodiments, a statement that two or more parts or components are "coupled" means that the parts are joined together and in direct contact with each other, unless specifically described in a different configuration. For example, as used herein, "indirectly coupled" means that two elements are in contact with each other through one or more intermediate parts or components. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so that they move as one while maintaining a constant orientation relative to each other. Consequently, when two elements are coupled, all portions of those elements are coupled. However, a description of a particular portion of a first element being coupled to a second element, e.g., the first end of an axle being coupled to a first wheel, means that the particular portion of the first element is positioned closer to the second element than the other portions. Furthermore, an object resting on another object held in place only by gravity is not "connected" to the object below unless the overlying object is otherwise substantially held in place. That is, for example, a book on a table is not connected to it, but a book glued to the table is connected to it.

[0039] In some embodiments, the systems and methods provided herein relate to reducing the risk of biohazards (e.g., live viruses) during the sample preparation process for analytical testing. For example, the outbreak of the COVID-19 pandemic has created a need for substantial testing outside of traditional laboratory and hospital environments. Some tests, such as lateral flow immunoassays, can be easily performed by inexperienced users (e.g., at home or in a clinic). The systems and methods provided herein offer new ways to minimize the risk of exposure of users, communities, healthcare workers, and laboratory personnel to dangerous agents, such as SARS-CoV-2 (the causative virus for COVID-19 disease), during sample preparation and testing.

[0040] The present invention is not limited by the nature of the hazardous material. In some embodiments, the material is chemical or biological. In some embodiments, the biological material is from a biological sample, such as saliva, mucus, urine, feces, blood or blood components (e.g., plasma, serum), wound compound, tissue, sweat, lesion components, and the like. In some embodiments, the hazardous agent associated with the biological material is a pathogen. Pathogens include, but are not limited to, viruses, bacteria, parasites, cells, and the like. In some embodiments, the sample is obtained from a human. In some embodiments, the sample is obtained from a non-human animal (e.g., a companion animal (e.g., dog, cat, horse, etc.), a livestock animal (e.g., cow, pig, chicken, etc.), or a wild animal (e.g., bird, fish, deer, tick, etc.)).

[0041] Swab Devices and Sample Collection Devices Many collection systems employ swab devices. As used herein, a swab device is an absorbent pad or piece of material used for wound cleansing, medication application, or specimen collection. In some embodiments, the swab device includes a swab tip that includes a small mass of absorbent material wound around one end (e.g., the distal end) of a small stick that provides a swab handle. The present technology is not limited by the nature of the material used for the swab tip. Suitable materials include nylon, rayon, cotton, polyester, polyurethane, and alginate polymers. Such materials can be formed into microstructures, including, but not limited to, tightly wound, woven, flocked fibers, and netted structures.

[0042] The swab end of the swab device typically contacts the sample to collect a portion of the sample, which is then available for transfer to an analytical assay device and / or analytical system for sample preparation and analytical testing.

[0043] Provided herein is a device for capturing or otherwise separating a sample from a swab device that has been in contact with a potentially hazardous sample. Several complementary and alternative embodiments are provided herein.

[0044] In some embodiments (e.g., as shown in Figures 1A-1K), the swab device (200) includes a swab handle (220) designed to be held by a user (e.g., the user's hand) at its proximal end (221) during sample collection. The distal end (222) of the swab handle (220) comprises the swab end (210). In some embodiments, the swab handle (220) comprises a breakable joint (230) between the proximal end (221) of the swab handle (220) and the swab end (210). In some embodiments, the breakable joint (130) is between approximately 5-9 cm from the end of the swab (e.g., approximately 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 6.10, 6.11, 6.12, 6.13, 6.14, 6.15, 6.16, 6.17, 6.18, 6.19, 6.20, 6.21, 6.22, 6.23, 6.24, 6.25, 6.26, 6.27, 6.28, 6.29, 6.30, 6.31, 6.32, 6.33, 6.34, 6.35, 6.36, 6.37, 6.38, 6.39, 6.40, 6.41, 6.42, 6.43, 6.44, 6.45, 6.46, 6.47, 6.48, 6.49, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.46, 6.47, 6. 4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10.0 cm). In some embodiments, the breakable joint (230) is a notched, serrated, scored, scored, or otherwise structurally weakened portion of the swab handle (220) that can be easily torn or broken to separate the swab end (210) from at least a portion of the swab handle (220) after the swab end (210) has collected a biological sample and been inserted into the extraction tube body (110). In some embodiments, the swab handle (220) is made of a flexible material, for example, a plastic such as polyethylene, polypropylene, polyester, polyvinyl chloride, acrylonitrile butadiene styrene, and polyamide (e.g., nylon).In some embodiments, the flexible material of the swab handle (220) facilitates bending of the swab handle (220) and placement of part or all of the swab device (200), including the swab handle (220), into the extraction tube body (110) (e.g., without even breaking the swab handle (220) at the breakable joint (230) to separate the swab end (210) from at least a portion of the swab handle (220), although both approaches may be used together).

[0045] In some embodiments (e.g., as shown in FIGS. 1A-1K), the present technology further provides a sample collection device (100) comprising an extraction tube body (110) that receives all or part of a swab device (200) and safely and securely separates the swab tip (210) containing the biological sample, preventing user exposure to potentially dangerous and / or biohazardous materials contained within the biological sample. Following sample collection, the swab tip (210) and at least a portion of any components associated with the swab tip (210), such as the swab handle (220), are placed within the extraction tube body (110) and stored therein by sealing the extraction tube body (110) with the top cap (120) and bottom cap (130). The extraction tube body (110) includes a fill line (111) that serves as a reference for filling the extraction tube body (110) with a buffer solution (e.g., provided by a dropper bottle (300)). In some embodiments, the extraction tube body (110) has a sufficient length above the fill line (111) to prevent splashing of the buffer solution (330) from reaching the top end (101) of the extraction tube body (110) when the buffer solution (330) is added to the extraction tube body (110).

[0046] Additionally, as described herein, the present technology provides several features that minimize the number of items requiring disposal and / or minimize the likelihood of hazardous materials being transferred outside of the collection component (e.g., coming into contact with users and / or the environment).

[0047] Exemplary collection components are shown in Figures 2A and 2B. As shown in Figure 2A, in some embodiments, the sample collection device comprises an extraction tube body (110). In some embodiments, the extraction tube body (110) includes an upper end (101), a middle portion (107), and a lower end (102). In some embodiments, the extraction tube body (110) has a length that is sufficiently long and narrow to minimize and / or eliminate splashing of the sample (e.g., biohazard material) out of the extraction tube body (110).

[0048] In some embodiments, the lower end (102) includes a dropper feature (103). In some embodiments, the dropper feature (103) is cylindrical. In some embodiments, the dropper feature (103) is generally conical and / or includes a frustum. In some embodiments, the dropper feature (103) includes a cylindrical portion and a generally conical and / or includes a frustum. In some embodiments, the dropper feature (103) includes some portion(s) that are cylindrical and some portion(s) that are generally conical and / or include a frustum. In some embodiments, the dropper feature (103) includes a beveled tip. In some embodiments, the dropper feature (103) has the same or similar diameter as the extraction tube body (110). In some embodiments, the dropper feature (103) has a diameter that is smaller than the diameter of the extraction tube body (110). In some embodiments, the extraction tube body (110) further comprises an optional lip (105) and a support flange (106). In some embodiments, the support flange (106) provides additional rigidity and / or support to the upper end (101) of the extraction tube body (110). In some embodiments, the lip (105) provides a stop to the top cap (120), for example, to prevent movement of the top cap (120) when coupled to the upper end (101) of the extraction tube body (110). In some embodiments, the lip (105) provides additional rigidity and / or support to the upper end (101) of the extraction tube body (110), for example, to maintain the circular cross-section of the upper end (101) of the extraction tube body (110), thus maximizing the area of ​​the opening at the upper end (101) of the extraction tube body (110) through which the swab device 200 can be inserted.

[0049] In some embodiments, the upper end (101) includes a set of upper threads (104). In some embodiments, the lower end (102) includes a set of lower threads (108). In some embodiments, the upper end (101) is configured to receive an upper cap (120) (e.g., as shown in Figures 3A, 3B, and 3C), e.g., the upper threads (104) are configured to engage with a set of threads (122) on the upper cap (120). In some embodiments, the lower end (102) is configured to receive a lower cap (130) (e.g., as shown in Figures 4A and 4B), e.g., the lower threads (108) are configured to engage with a set of threads (132) on the lower cap (130). Accordingly, embodiments provide that the upper cap (120) is coupled to the upper end (101) and / or the lower cap (130) is coupled to the upper end (102).

[0050] However, the present technology is not limited to the connection method utilized in connecting the top cap (120) to the top end (101) and / or in connecting the bottom cap (130) to the bottom end (102). In the illustrated embodiment, the top cap (120) is connected to the top end (101) by a threaded connection. In some embodiments, the top cap (120) and the top end (101) are connected together by another suitable mechanical connection type (e.g., a snap-type connection, a press-fit connection, a barb connection, a bayonet-type connection, a tab-and-slot connection, etc.). Thus, the top cap (120) is secured to the top end (101) by a mechanical connection. In the illustrated embodiment, the top cap (120) is secured to and released from the top end (101) by the threaded connection without the use of tools (e.g., the connection is a tool-less connection).

[0051] In the illustrated embodiment, bottom cap (130) is coupled to bottom end (102) via a threaded connection. In some embodiments, bottom cap (130) and bottom end (102) are coupled together via another suitable mechanical connection type (e.g., a snap-type connection, a press-fit connection, a barbed connection, a bayonet-type connection, a tab-and-slot connection, etc.). Thus, bottom cap (130) is secured to bottom end (102) via a mechanical connection. In the illustrated embodiment, bottom cap (130) is secured to and released from bottom end (102) via the threaded connection without the use of tools (e.g., the connection is a tool-less connection).

[0052] An exemplary top cap (120) is shown in Figures 5A and 5B. In some embodiments, the top cap (120) includes a plurality of ridges (121) around its periphery. In some embodiments, the ridges (121) increase friction between a user's fingers and the top cap (120), thus making it easier for the user to grasp and manipulate (e.g., rotate) the top cap (120).

[0053] In some embodiments, a user manipulates (e.g., rotates) top cap (120) to place top cap (120) on extraction tube body (110), for example, by engaging threads (122) of top cap (120) with top threads (104) and rotating top cap (120) relative to extraction tube body (110) to couple top cap (120) with extraction tube body (110). In some embodiments, a user manipulates (e.g., rotates) top cap (120) to remove top cap (120) from extraction tube (100), for example, by rotating top cap (120) relative to extraction tube body (110) to disengage threads (122) of top cap (120) from top threads (104) to separate top cap (120) from extraction tube body (110). In some embodiments, the top cap (120) includes a plurality of ridges (121) that increase friction between the user's fingers and the top cap (120), thus making it easier for the user to grasp and manipulate (e.g., rotate) the top cap (120).

[0054] In some embodiments, a user manipulates (e.g., rotates) bottom cap (130) to place bottom cap (130) on extraction tube body (110), for example, by engaging threads (132) of bottom cap (130) with bottom threads (108) and rotating bottom cap (130) relative to extraction tube body (110) to couple bottom cap (130) with extraction tube body (110). In some embodiments, a user manipulates (e.g., rotates) bottom cap (130) to remove bottom cap (130) from extraction tube body (110), for example, by rotating bottom cap (130) relative to extraction tube body (110) to disengage threads (132) of bottom cap (130) from bottom threads (108) to separate bottom cap (130) from extraction tube body (110). In some embodiments, the bottom cap (130) includes a plurality of ridges (131) that increase friction between the user's fingers and the bottom cap (130), thus making it easier for the user to grasp and manipulate (e.g., rotate) the bottom cap (130).

[0055] In some embodiments, the swab device 200 has a length that is greater than the length of the central portion 107 of the extraction tube body 110 plus the length of the upper end 101 of the extraction tube body 110, e.g., so that when the swab device 200 is inserted into the extraction tube body 110 and the swab end 210 of the swab device 200 is adjacent to the lower end 102 of the extraction tube body 110, a portion of the swab device 200 (e.g., a portion of the swab handle 220) extends from the top of the extraction tube body 110. See, e.g., FIG. 1C.

[0056] For example, as shown in FIG. 1A, the swab device (200) has a length defined by a swab end (210) and a swab handle (220). When the swab device (200) is unbroken and the swab end (210) is positioned within the extraction tube body (110) adjacent the lower end (102) of the extraction tube body (110), the proximal end (221) of the swab handle (220) extends beyond the upper end (101) of the extraction tube body (110). See, e.g., FIG. 1C. As shown in FIG. 1A, the swab handle (220) of the swab device (200) includes a breakable joint (230). In some embodiments, the breakable joint (230) is a notched, serrated, scored, scored, or otherwise structurally weakened portion of the swab handle (220) that can be easily torn or broken to separate the swab end (210) from at least a portion of the swab handle (220). After the swab handle (220) of the swab device (200) breaks at the breakable joint (230) (e.g., as shown in FIG. 1D), the swab device (200) includes the swab end (210) and, in some embodiments, at least a portion of the swab handle (220). The broken swab device (200) has a length that fits completely, essentially completely, and / or substantially completely within the extraction tube body (110) (e.g., as shown in FIG. 1E). Accordingly, the top cap (120) can be placed on the extraction tube body (110) (e.g., as shown in FIG. 1F), for example, by connecting the top cap (120) to the upper end (101) of the extraction tube body (110) (e.g., by engaging the threads (122) of the top cap (120) with the lower end threads (108)).

[0057] Accordingly, in some embodiments, for example, as shown in Figures 2A and 2B, the combined length of the middle portion (107) and upper portion (101) of the extraction tube body (110) is approximately 87.9 mm (e.g., approximately 78.0, 78.1, 78.2, 78.3, 78.4, 78.5, 78.6, 78.7, 78.8, 78.9, 79.0, 79.1, 79.2, 79.3, 79.4, 79.5, 79.6, 79.7, 79.8, 79.9, 80.0, 80.1, 80.2, 80.3, 80.4, 80.5, 80.6, 80.7, 80.8, 80.9, 81. 0, 81.1, 81.2, 81.3, 81.4, 81.5, 81.6, 81.7, 81.8, 81.9, 82.0, 82.1, 82.2, 82.3, 82.4, 82.5, 82.6, 82.7, 82.8, 82.9, 83.0, 83.1, 83.2, 83.3, 83.4, 83. 5, 83.6, 83.7, 83.8, 83.9, 84.0, 84.1, 84.2, 84.3, 84.4, 84.5, 84.6, 84.7, 84.8, 84.9, 85.0, 85.1, 85.2, 85.3, 85.4, 85.5, 85.6, 85.7, 85.8, 85.9, 86. 0, 86.1, 86.2, 86.3, 86.4, 86.5, 86.6, 86.7, 86.8, 86.9, 87.0, 87.1, 87.2, 87.3, 87.4, 87.5, 87.6, 87.7, 87.8, 87.9, 88.0, 88.1, 88.2, 88.3, ​​88.4, 88. 5, 88.6, 88.7, 88.8, 88.9, 89.0, 89.1, 89.2, 89.3, 89.4, 89.5, 89.6, 89.7, 89.8, 89.9, 90.0, 90.1, 90.2, 90.3, 90.4, 90.5, 90.6, 90.7, 90.8, 90.9, 91. 0, 91.1, 91.2, 91.3, 91.4, 91.5, 91.6, 91.7, 91.8, 91.9, 92.0, 92.1, 92.2, 92.3, 92.4, 92.5, 92.6, 92.7, 92.8, 92.9, 93.0, 93.1, 93.2, 93.3, 93.4, 93. 5, 93.6, 93.7, 93.8, 93.9, 94.0, 94.1, 94.2, 94.3, 94.4, 94.5, 94.6, 94.7, 94.8, 94.9, 95.0, 95.1, 95.2, 95.3, 95.4, 95.5, 95.6, 95.7, 95.8, 95.9, 96.0, 96.1, 96.2, 96.3, 96.4, 96.5, 96.6, 96.7, 96.8, 96.9, 97.0, 97.1, 97.2, 97.3, 97.4, 97.5, 97.6, 97.7, 97.8, 97.9, or 98.0 mm).

[0058] Thus, in some embodiments, the swab device is greater than approximately 87.9 mm (e.g., approximately 78.0, 78.1, 78.2, 78.3, 78.4, 78.5, 78.6, 78.7, 78.8, 78.9, 79.0, 79.1, 79.2, 79.3, 79.4, 79.5, 79.6, 79.7, 79.8, 79.9, 80.0, 80.1, 80.2, 80.3, 80.4, 80.5, 80.6, 80.7, 80.8, 80.9, 81.0, 81.1, 81.2, 81.3, 81.4, 81.5, 81.6, 81.7, 81.8, 81.9, 82 .0, 82.1, 82.2, 82.3, 82.4, 82.5, 82.6, 82.7, 82.8, 82.9, 83.0, 83.1, 83.2, 83.3, 83.4, 83.5, 83.6, 83.7, 83.8, 83.9, 84.0, 84.1, 84.2, 84.3, 84.4, 84 .5, 84.6, 84.7, 84.8, 84.9, 85.0, 85.1, 85.2, 85.3, 85.4, 85.5, 85.6, 85.7, 85.8, 85.9, 86.0, 86.1, 86.2, 86.3, 86.4, 86.5, 86.6, 86.7, 86.8, 86.9, 87 .0, 87.1, 87.2, 87.3, 87.4, 87.5, 87.6, 87.7, 87.8, 87.9, 88.0, 88.1, 88.2, 88.3, ​​88.4, 88.5, 88.6, 88.7, 88.8, 88.9, 89.0, 89.1, 89.2, 89.3, 89.4, 89 .5, 89.6, 89.7, 89.8, 89.9, 90.0, 90.1, 90.2, 90.3, 90.4, 90.5, 90.6, 90.7, 90.8, 90.9, 91.0, 91.1, 91.2, 91.3, 91.4, 91.5, 91.6, 91.7, 91.8, 91.9, 92 .0, 92.1, 92.2, 92.3, 92.4, 92.5, 92.6, 92.7, 92.8, 92.9, 93.0, 93.1, 93.2, 93.3, 93.4, 93.5, 93.6, 93.7, 93.8, 93.9, 94.0, 94.1, 94.2, 94.3, 94.4, 94 .5, 94.6, 94.7, 94.8, 94.9, 95.0, 95.1, 95.2, 95.3, 95.4, 95.5, 95.6, 95.7, 95.8, 95.9, 96.0, 96.1, 96.2, 96.3, 96.4, 96.5, 96.6, 96.7, 96.8, 96.9, 97.0, 97.1, 97.2, 97.3, 97.4, 97.5, 97.6, 97.7, 97.8, 97.9, or 98.0 mm).

[0059] In some embodiments, the swab device and / or swab handle is approximately 70-100 mm (e.g., 70.0, 70.1, 70.2, 70.3, 70.4, 70.5, 70.6, 70.7, 70.8, 70.9, 71.0, 71.2, 71.4, 71.6, 71.8, 72.0, 72.2, 72.4, 72.6, 72.8, 73.0, 73.2, 73.4, 73.6, 73.8, 74.0, 74.2, 74.4, 74.6, 74.8, 75.0, 75.2, 75.3, 75.4, 75.5, 75.6, 75.7, 75.8, 75.9, 76.0, 76.1, 76.1, 76.2, 76.3, 76.4, 76.5, 76.6, 76.7, 76.8, 77.0, 77.1, 77.2, 77.3, 77.4, 77.5, 77.6, 77.8, 78.0, 78.1, 78.2, 78.3, 78.4, 78.5, 78.6, 78.7, 78.8, 79.0, 79.1, 80.1, 80.1, 80.2, 80.3, 80.4, 80.5, 80.6, 80.7, 80.8, 80.9, 81.0, 81.2 5.4, ​​75.6, 75.8, 76.0, 76.2, 76.4, 76.6, 76.8, 77.0, 77.2, 77.4, 77.6, 77.8, 78.0, 78.2, 78.4, 78.6, 78.8, 79.0, 79.2, 79.4, 79.6, 79.8, 80.0, 80.2, 80.4, 80.6, 80.8, 81.0, 81.2, 81.4, 81.6, 81.8, 82.0, 82.2, 82.4, 82.6, 82.8, 83.0, 83.2, 83.4, 83.6, 83 .8, 84.0, 84.2, 84.4, 84.6, 84.8, 85.0, 85.2, 85.4, 85.6, 85.8, 86.0, 86.2, 86.4, 86.6, 86.8, 87.0, 87.2, 87.4, 87.6, 87.8, 88.0, 88.2, 88.4, 88.6, 88.8, 89.0, 89.2, 89.4, 89.6, 89.8, 90.0, 90.2, 90.4, 90.6, 90.8, 91.0, 91.2, 91.4, 91.6, 91.8, 92.0, 92. 97.0, 97.2, 97.4, 97.6, 97.8, 98.0, 98.2, 98.4, 98.6, 98.8, 99.0, 99.2, 99.4, 99.6, 99.8, or 100.0 mm).

[0060] In some embodiments, for example, as shown in FIG. 4B, the top end (101) is approximately 7.8 mm (e.g., approximately 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.1, 13.2, 13.3, 13.4, 13.5, 8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, or 11.0 mm) (e.g., in embodiments excluding the optional lip ) or approximately 9.6 mm (e.g., approximately 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4 , 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, or 13.0 mm) (e.g., in embodiments including an optional lip).In some embodiments, for example, as shown in FIG. 4B, the central portion (107) of the extraction tube body (110) is approximately 10.5 mm (e.g., 7.0, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, or 13.0 mm). In some embodiments, the extraction tube body (110) (e.g., the upper end (101) and / or the middle portion (107) of the extraction tube body (110)) has an inner diameter of approximately 9 mm (e.g., 8.0, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9, 9.0, 9.1, 9.2, 9.3, 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, or 10.0 mm).

[0061] In some embodiments, for example, as shown in FIG. 4B, the lower end (102) is approximately 13 mm (e.g., approximately 10.0, 10.1, 10.2, 10.3, 10.4, 10.5, 10.6, 10.7, 10.8, 10.9, 11.0, 11.1, 11.2, 11.3, 11.4, 11.5, 11.6, 11.7, 11.8, 11.9, 12.0, 12.1, 12.2, 12.3, 12.4, 12.5, 12.6, 12.7, 12.8, 12.9, 13.0, 13.1, 13.2, 13.3, 13.4, 13.5, 13.6, 13.7, 13.8, 13.9, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.10, 15.11, 15.12, 15.13, 15.14, 15.15, 15.16, 15.17, 15.18, 15.19, 16.20, 16.21, 16.22, 16.23, 16.24, 16.25, 16.26, 16.27, 16.28, 16.29, 16.30, 16.31, 16.32, 16.33, 14.0, 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 15.0, 15.1, 15.2, 15.3, 15.4, 15.5, 15.6, 15.7, 15.8, 15.9, or 16.0 mm). In some embodiments, for example, as shown in FIG. 4B, dropper feature (103) has an outer diameter of approximately 2.5 mm (e.g., approximately 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5 mm). In some embodiments, dropper feature (103) has an inner diameter of approximately 1.6 mm (e.g., approximately 1.00, 1.05, 1.10, 1.15, 1.20, 1.25, 1.30, 1.35, 1.40, 1.45, 1.50, 1.55, 1.60, 1.65, 1.70, 1.75, 1.80, 1.85, 1.90, 1.95, or 2.00 mm). In some embodiments, the dropper feature (103) dispenses (e.g., outputs) 1 to 10 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10) droplets of sample. In some embodiments, the droplets of sample are approximately 50 μl (e.g., approximately 40.0, 40.1, 40.2, 40.3, 40.4, 40.5, 40.6, 40.7, 40.8, 40.9, 41.0, 41.1, 41.2, 41.3, 41.4, 41.5, 41.6, 41.7, 41.8, 41.9, 41.10, 41.11, 41.12, 41.13, 41.14, 41.15, 41.16, 41.17, 41.18, 41.19, 41.20, 41.21, 41.22, 41.23, 41.24, 41.25, 41.26, 41.27, 41.28, 41.29, 41.30, 41.31, 41.32, 41.33, 41.34, 41.35, 41.36, 41.37, 41.38, 41.39, 41.40, 41.41, 41.42, 41.43, 41.44, 41.45, 41.46, 41.47, 41.48, 41.49, 42.50, 42.51, 4 2.0, 42.1, 42.2, 42.3, 42.4, 42.5, 42.6, 42.7, 42.8, 42.9, 43.0, 43.1, 43.2, 43.3, 43.4, 43.5, 43.6, 43.7, 43.8, 43.9, 44.0, 44.1, 44.2, 44.3, 44.4, 44.5, 44.6, 44.7, 44.8, 44.9, 45.0, 45.1, 45.2, 45.3, 45.4, 45.5, 45.6, 45.7, 45.8, 45.9, 46.0, 46.1, 46.2, 46.3, 46.4, 46.5, 46.6, 46.7, 46.8, 46.9, 47.0, 47.1, 47.2, 47.3, 47.4, 47.5, 47.6, 47.7, 47.8, 47.9, 48.0, 48.1, 48.2, 48.3, 48.4, 48.5, 48 .6, 48.7, 48.8, 48.9, 49.0, 49.1, 49.2, 49.3, 49.4, 49.5, 49.6, 49.7, 49.8, 49.9, 50.0, 50.1, 50.2, 50.3, 50.4, 50.5, 50.6, 50.7, 50.8, 50.9, 51.0, 51.1, 51.2, 51.3, 51.4, 51.5, 51.6, 51.7, 51.8, 51.9, 52.0, 52.1, 52.2, 52.3, 52.4, 52.5 .5, 52.6, 52.7, 52.8, 52.9, 53.0, 53.1, 53.2, 53.3, 53.4, 53.5, 53.6, 53.7, 53.8, 53.9, 54.0, 54.1, 54.2, 54.3, 54.4, 54.5, 54.6, 54.7, 54.8, 54.9, 55.0, 55.1, 55.2, 55.3, 55.4, 55.5, 55.6, 55.7, 55.8, 55.9, 56.0, 56.1, 56.2, 56.3, 56.4, 56.5, 56.6, 56.7, 56.8, 56.9, 57.0, 57.1, 57.2, 57.3, 57.4, 57.5, 57.6, 57.7, 57.8, 57.9, 58.1, 58.2, 58.3, 58.4, 58.5, 58.6, 58.7, 58.8, 58.9, 59.0, 59.1, 59.2, 59.3, 59.4, 59.5, 59.6, 59.7, 59.8, 59.9, 60.0, 60.1, 60.2, 60.3, 60.4, 60.5, 60.6, 60.7, 60.8, 60.9, 61.1, 61 56.4, 56.5, 56.6, 56.7, 56.8, 56.9, 57.0, 57.1, 57.2, 57.3, 57.4, 57.5, 57.6, 57.7, 57.8, 57.9, 58.0, 58.1, 58.2, 58.3, 58.4, 58.5, 58.6, 58.7, 58.8, 58.9, 59.0, 59.1, 59.2, 59.3, 59.4, 59.5, 59.6, 59.7, 59.8, 59.9, or 60.0 μl).

[0062] The present technology is not limited by the material from which the extraction tube body is made. For example, in some embodiments, the extraction tube body is made from a bendable and / or flexible polymer. Examples of flexible polymers include, for example, polyethylene (e.g., high density polyethylene (HDPE), low density polyethylene (LDPE)), polypropylene, polyamide, and similar materials.

[0063] As shown in Figure 5A, in some embodiments, the extraction tube body (110) includes a separation component (140) that facilitates separation of the swab end (210) from at least a portion of the swab handle (220). For example, in some embodiments, the separation component (140) includes a cutting edge or cutting ridge that facilitates separation of the swab end (210) from at least a portion of the swab handle (220) after the swab device (200) is inserted into the extraction tube body (110). In some embodiments, the separation component (140) is positioned to interact with the breakable joint (230) to facilitate breaking the swab handle (220) at the breakable joint (230). In some embodiments, the breakable joint (230) is a notched, serrated, scored, scored, or otherwise structurally weakened portion of the swab handle (220) that can be easily torn or broken (e.g., by interacting with the separation component (140)) to separate the swab tip (210) from at least a portion of the swab handle (220). As shown in Figure 5B, in some embodiments, a user pinches (700) the extraction tube body (110) to cause the separation component (140) to interact with the breakable joint (230) and break the swab handle (220) at the breakable joint (230).

[0064] kit In some embodiments, kits are provided that include components useful, necessary, or sufficient for sample collection and / or sample processing and analysis. In some embodiments, the kits include one or more bottles or other containers containing a buffer solution or the like (e.g., a storage buffer that stabilizes the sample for shipping and / or storage). In some embodiments, for example, as shown in FIGS. 1A-1K, the present technology provides kits including a swab device (200) and a collector (100). In some embodiments, the extraction tube body (110) of the collector (100) contains the buffer solution; for example, in some kit embodiments, the extraction tube body (110) of the collector (100) is pre-filled with a buffer solution (330). In some embodiments, the present technology provides kits including a swab device (200), a collector (100), and a dropper bottle (300) containing the buffer solution (330). In some embodiments, a user of the kit adds the buffer solution (330) to the extraction tube body (110) of the collector (100). The present technology is not limited by how a user adds the buffer solution 330 to the extraction tube body 110 of the collector 100. While the exemplary embodiment provides a dropper bottle 300 containing the buffer solution 330, embodiments also provide that the buffer solution 330 is added to the extraction tube body 110 of the collector 100 by a user using a pipette, from a vial, by pouring, etc. In some embodiments, the buffer solution 330 is provided in a pre-measured amount, and the user adds the entire amount of buffer solution 330 to the extraction tube body 110 of the collector 100. In some embodiments, the buffer solution 330 is provided in a volume greater than the volume to be added to the extraction tube body 110 of the collector 100, and the user measures the appropriate amount of buffer solution 330 to be added to the extraction tube body 110 of the collector 100. In some embodiments, the user adds buffer solution (330) to the extraction tube body (110) of the collector (100) until the buffer solution (330) reaches the fill line on the extraction tube body (110) of the collector.

[0065] In some embodiments, the present technology provides a kit comprising: a) a swab device (200) including a swab tip (210) and a swab handle (220); b) a sample collection device (100) including an extraction tube body (110) including a dropper feature (103); and c) a buffer solution (330) (e.g., a dropper bottle (300) including a dropper bottle body (310) containing the buffer solution (330) and a dropper bottle cap (320). In some embodiments, the sample collection device (100) of the kit comprises an upper cap (120) and a lower cap (130). In some embodiments, the extraction tube body (110) comprises an upper end (101) configured to receive the upper cap (120), and the extraction tube body (110) comprises a lower end (102) configured to receive the lower cap (130). In some embodiments, the swab device (200) of the kit includes a breakable joint (230). In some embodiments, the swab handle (220) of the swab device (200) includes the breakable joint (230). In some embodiments, the swab handle (220) of the swab device (200) includes a proximal end (221) and a distal end (222), the swab handle (220) includes a swab end (210) at the distal end (222), and the swab handle (220) includes the breakable joint (230) between the proximal end (221) of the swab handle (220) and the distal end (222) of the swab handle (220). In some embodiments, the kit further includes an analytical assay device (600). In some embodiments, the kit further includes a biohazard waste container (999). In some embodiments, the extraction tube body (110) of the collection device (100) of the kit includes a fill line (111). As shown in Figures 5A and 5B, in some embodiments, the extraction tube body (110) includes a separation component (140) that interacts with the breakable joint (230) to facilitate breaking of the swab handle (220) at the breakable joint (230).

[0066] system In some embodiments, a system is provided that includes components useful, necessary, or sufficient for sample collection and / or sample processing and analysis. In some embodiments, the system includes one or more bottles or other containers containing a buffer solution or the like (e.g., a storage buffer that stabilizes the sample for shipping and / or storage). In some embodiments, for example, as shown in FIGS. 1A-1K, the present technology provides a system including a swab device (200) and a collector (100). In some embodiments, the extraction tube body (110) of the collector (100) includes a buffer solution; for example, in some embodiments of the system, the extraction tube body (110) of the collector (100) is pre-filled with a buffer solution (330). In some embodiments, the present technology provides a system including a swab device (200), a collector (100), and a dropper bottle (300) that includes a buffer solution (330). In some embodiments, a user of the system adds the buffer solution (330) to the extraction tube body (110) of the collector (100). The present technology is not limited by how a user adds the buffer solution 330 to the extraction tube body 110 of the collector 100. While the exemplary embodiment provides a dropper bottle 300 containing the buffer solution 330, embodiments also provide that the buffer solution 330 is added to the extraction tube body 110 of the collector 100 by a user using a pipette, from a vial, by pouring, etc. In some embodiments, the buffer solution 330 is provided in a pre-measured amount, and the user adds the entire amount of buffer solution 330 to the extraction tube body 110 of the collector 100. In some embodiments, the buffer solution 330 is provided in a volume greater than the volume to be added to the extraction tube body 110 of the collector 100, and the user measures the appropriate amount of buffer solution 330 to be added to the extraction tube body 110 of the collector 100. In some embodiments, the user adds buffer solution (330) to the extraction tube body (110) of the collector (100) until the buffer solution (330) reaches the fill line on the extraction tube body (110) of the collector.

[0067] In some embodiments, the present technology provides a system comprising: a) a swab device (200) including a swab tip (210) and a swab handle (220); b) a sample collection device (100) including an extraction tube body (110) including a dropper feature (103); and c) a buffer solution (330) (e.g., a dropper bottle (300) including a dropper bottle body (310) containing the buffer solution (330) and a dropper bottle cap (320). In some embodiments, the sample collection device (100) of the system includes a top cap (120) and a bottom cap (130). In some embodiments, the extraction tube body (110) includes a top end (101) configured to receive the top cap (120), and the extraction tube body (110) includes a bottom end (102) configured to receive the bottom cap (130). In some embodiments, the swab device (200) of the system includes a breakable joint (230). In some embodiments, the swab handle (220) of the swab device (200) includes the breakable joint (230). In some embodiments, the swab handle (220) of the swab device (200) includes a proximal end (221) and a distal end (222), the swab handle (220) includes a swab end (210) at the distal end (222), and the swab handle (220) includes the breakable joint (230) between the proximal end (221) of the swab handle (220) and the distal end (222) of the swab handle (220). In some embodiments, the system further includes an analytical assay device (600). In some embodiments, the system further includes a reader device for reading test results provided by the analytical assay device (600). In some embodiments, the system further comprises a biohazard waste container (999). In some embodiments, the extraction tube body (110) of the collection device (100) of the system comprises a fill line (111). As shown in Figures 5A and 5B, in some embodiments, the extraction tube body (110) comprises a separation component (140) that interacts with the breakable joint (230) to facilitate breaking of the swab handle (220) at the breakable joint (230).

[0068] How to Use the Swab Device Sample Collection Device In some embodiments, the method includes providing a swab device and a collection device. In some embodiments, the method includes providing a swab device, a collection device, and a dropper bottle containing a buffer solution (see, e.g., FIG. 1A). In some embodiments, the method includes providing a kit or system including the swab device and the collection device. In some embodiments, the method includes providing a kit or system including the swab device, a collection device, and a dropper bottle containing a buffer solution.

[0069] In some embodiments, the method includes adding a buffer solution or extraction solution (e.g., approximately 300 μL (e.g., 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, or 350 μL)) to a sample collection device (e.g., an extraction tube body) (see, e.g., FIG. 1B). In some embodiments, the method includes observing that the buffer solution is above a fill line provided on the extraction tube body and / or confirming that approximately 300 μL has been added to the extraction tube body, e.g., as shown in FIG. 1B. In some embodiments, the method includes acquiring a sample on a swab device including a swab handle (e.g., acquiring a sample on the swab end of the swab device), placing the swab device into a sample collection device (e.g., an extraction tube body) (see, e.g., FIG. 1C), and optionally moving the swab device to facilitate transfer of at least a portion of the analytes in the sample from the swab end to a buffer solution in the extraction tube (e.g., by rotating the swab handle approximately five times (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times) (see, e.g., FIG. 1C). Then, in some embodiments, the method includes removing the swab handle, or a portion thereof, from the swab device (e.g., by breaking the swab handle at a breakable joint) (see, e.g., FIG. 1D). In some embodiments, removing the swab handle from the swab device comprises pinching the extraction tube body and / or breaking the swab handle while the swab handle is inside the extraction tube body (e.g., embodiments provide that the user touches the outside of the extraction tube body to break the swab handle, but does not touch the swab handle to break it). In some embodiments, the method comprises pinching the extraction tube body to cause a separation component to interact with the breakable joint to facilitate removal of the swab handle, or a portion thereof, from the swab device (e.g., by breaking the swab handle at the breakable joint) (see, e.g., Figures 5A and 5B). Consequently, in some embodiments, the method comprises contacting a separation component of the extraction tube body with the breakable joint.In some embodiments, the method further comprises sealing the extraction tube body with an upper cap (see, e.g., Figures 1E and 1F), for example, by connecting the upper cap to the upper end of the extraction tube body. In some embodiments, the method further comprises removing the lower cap from the dropper feature (e.g., from the lower end of the extraction tube body) (see, e.g., Figure 1I). In some embodiments, the method further comprises removing and / or outputting one or more droplets (e.g., approximately 5 droplets (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 droplets)) from the extraction tube body (e.g., from the dropper feature) (see, e.g., Figure 1J). In some embodiments, removing and / or outputting the one or more droplets from the extraction tube body comprises squeezing the extraction tube body (see, e.g., Figure 1J) to increase pressure inside the extraction tube body and force the droplets out of the dropper feature. In some embodiments, the droplets are dispensed onto sample wells of an analytical assay device (see, e.g., FIG. 1J), such as the lateral flow assay device described in International Patent Application No. PCT / US21 / 026183, incorporated herein by reference. In some embodiments, the method includes observing and / or reading the test results. In some embodiments, observing and / or reading the test results includes observing one or more visually detectable result lines on the test cassette. In some embodiments, observing and / or detecting the presence of only a control line (C) and no test line (T) indicates a negative result, while the presence of both a test line (T) and a control line (C) indicates a positive result, regardless of which line appears first. In some embodiments, the presence of a test line (T), no matter how faint, indicates a positive result. In some embodiments, if the control line (C) is not visible after running the test, the result is considered invalid. In some embodiments, the method includes discarding the collection device and / or analytical assay device (e.g., a lateral flow assay device) (see, e.g., FIG. 1K).

[0070] In some embodiments, the method includes adding a buffer solution or extraction solution (e.g., approximately 300 μL (e.g., 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, or 350 μL)) to a sample collection device (e.g., an extraction tube body) (see, e.g., FIG. 1B). In some embodiments, the method includes observing that the buffer solution is above a fill line provided on the extraction tube body and / or confirming that approximately 300 μL has been added to the extraction tube body, e.g., as shown in FIG. 1B. In some embodiments, the method includes acquiring a sample on a swab device including a swab handle (e.g., acquiring a sample on the swab end of the swab device), placing the swab device into a sample collection device (e.g., an extraction tube body) (see, e.g., FIG. 1C ), and optionally moving the swab device to facilitate transfer of at least a portion of the analytes in the sample from the swab end to a buffer solution in the extraction tube (e.g., by rotating the swab handle approximately five times (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times)). In some embodiments, the method further includes sealing the extraction tube body with a top cap (see, e.g., FIG. 1E and FIG. 1F ), e.g., by connecting the top cap to the upper end of the extraction tube body. In some embodiments, the swab handle is flexible, and the method includes bending and / or compressing the swab handle to seal the extraction tube body with the top cap (see, e.g., FIG. 1G and FIG. 1H ). As a result, in some embodiments, the swab handle is not broken, but instead is bent and / or compressed to seal the swab device, including the swab handle and swab end, within the extraction tube body. In some embodiments, the method further includes removing the bottom cap from the dropper feature (e.g., from the lower end of the extraction tube body) (see, e.g., FIG. 1I). In some embodiments, the method further includes removing and / or outputting one or more droplets (e.g., approximately 5 droplets (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 droplets)) from the extraction tube body (e.g., from the dropper feature) (see, e.g., FIG. 1J).In some embodiments, removing and / or outputting one or more droplets from the extraction tube body includes squeezing the extraction tube body (e.g., see FIG. 1J ) to increase pressure inside the extraction tube body and force the droplets out of the dropper feature. In some embodiments, the droplets are dispensed onto a sample well of an analytical assay device (e.g., see FIG. 1J ), such as the lateral flow assay device described in International Patent Application No. PCT / US21 / 026183, incorporated herein by reference. In some embodiments, the method includes observing and / or reading the test result. In some embodiments, observing and / or reading the test result includes observing one or more visually detectable result lines on the test cassette. In some embodiments, observing and / or detecting the presence of only the control line (C) and the absence of the test line (T) indicates a negative result, while the presence of both the test line (T) and the control line (C) indicates a positive result, regardless of which line appears first. In some embodiments, the presence of the test line (T), no matter how faint, indicates a positive result. In some embodiments, if the control line (C) is not visible after the test is performed, the result is considered invalid. In some embodiments, the method includes discarding the collection device and / or the lateral flow assay device (see, e.g., Figure 1K).

[0071] One exemplary embodiment is shown in FIGS. 1A-1J. A dropper bottle (300) containing a buffer solution is provided to the swab device (200) and the sample collection device (100). A buffer solution (330) is added to the extraction tube body (110) (FIG. 1B). In some embodiments, the extraction tube body (110) includes a fill line or markings indicating the appropriate amount of buffer solution (330) to add to the extraction tube body (110) (e.g., approximately 300 μL (e.g., approximately 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, or 350 μL)). The swab device (200) (e.g., the swab end (210) of the swab device (200)) contacts the biological sample (e.g., a nasopharyngeal sample). The swab end (210) of the swab device (200) is inserted into the extraction tube body (110) with the swab handle (220) extending outside the extraction tube body (FIG. 1C). In some embodiments, the swab end (210) is crushed to release at least a portion of the analytes in the sample (e.g., biological material) into the buffer solution (330). Crushing can be facilitated by any desired mechanism. In some embodiments, the swab end (210) is pressed against the interior surface of the extraction tube body (110) (e.g., against the interior surface of the extraction tube body (110)). In some embodiments, the interior of the extraction tube body (110) is shaped to compress and crush the swab end (210), for example, by having a diameter near the lower end (102) of the extraction tube body (110) that is smaller than the diameter of the uncrushed swab end (210). In some embodiments, the swab device (200) is spun or rotated (800) to release at least a portion of the analytes in the sample (e.g., including biological material) into the buffer solution (330).

[0072] Next, in some embodiments, at least a portion of the swab handle (220) of the swab device (200) is separated from the swab end (210) (FIG. 1D). This can be accomplished by cutting, breaking, or any desired mechanism. In some embodiments, the swab handle (220) includes a breakable joint (230) that facilitates cutting, breaking, or any desired mechanism to separate at least a portion of the swab handle (220) of the swab device (200).

[0073] In some embodiments, removing at least a portion of the swab handle (220) of the swab device (200) from the swab end (210) comprises pinching the extraction tube body (110) while the swab handle (220) is inside the extraction tube body (110) (FIG. 5B) and / or breaking the swab handle (220) (e.g., embodiments provide that the user touches the outside of the extraction tube body (110) to break the swab handle (220), but the user does not touch the swab handle (220) to break it). In some embodiments, the method includes grasping the extraction tube body (110) to cause the separation component (140) to interact with the breakable joint (130) to facilitate removal of the swab handle (220), or a portion thereof, from the swab device (200) (e.g., by breaking the swab handle (220) at the breakable joint (230)) (see, e.g., FIGS. 5A and 5B). Consequently, in some embodiments, the method includes contacting the separation component (140) of the extraction tube body (110) with the breakable joint (130). The top cap (120) is then secured to the extraction tube body (110) to secure the entire swab end (210) (and any remaining portion of the swab handle (220) connected to the swab end (210)) within the interior space of the extraction tube body (110) (FIGS. 1E and 1F).

[0074] In some embodiments, the swab handle (220) is flexible, and the method includes bending and / or compressing the swab handle (220) to seal the extraction tube body (110) with the top cap (120) (FIGS. 1G and 1H). As a result, in some embodiments, the swab handle (220) is not broken, but instead is bent and / or compressed to completely seal the swab device (200), including the swab handle (220) and swab tip (210), within the extraction tube body (110). FIG. 1G and 1H. Thus, in some embodiments, the top cap (120) is secured to the extraction tube body (110) to secure the entire swab device (200), including the swab tip (210) and swab handle (220), within the interior space of the extraction tube body (110) (FIGS. 1G and 1H).

[0075] In some embodiments, the extraction tube body (110) includes a dropper feature (103) at its lower end (102). The dropper feature (103) can be accessed by removing the bottom cap (130) to expose the dropper feature (103) (FIG. 1I). One or more droplets of buffer solution (330) containing the biological sample (500) (e.g., containing an analyte) can then be expelled from the extraction tube body (110) (FIG. 1J). In some embodiments, removing the droplets of buffer solution (330) containing at least a portion of the biological sample (500) (e.g., containing an analyte) includes squeezing the extraction tube body (110) (FIG. 1J). The droplets (500 / 330) can be delivered directly to an analytical assay device (600) (FIG. 1J) for further sample preparation or directly for analytical analysis. For example, the droplet (500 / 330) can be applied to an analytical assay device (600) (e.g., a lateral flow assay device) that provides a yes / no answer regarding the presence of a particular substance (e.g., an analyte, such as a pathogen protein, pathogen nucleic acid, chemical, hormone, etc.) in a sample. See, e.g., International Patent Application No. PCT / US21 / 026183, incorporated herein by reference. The bottom cap (130) can then be reattached to the extraction tube body (110), storing the swab device (200) (e.g., including at least a portion of the swab tip (210) and swab handle (220)) and any unused biological sample within the sample collection device 100 (e.g., within the extraction tube body (110)) (FIG. 1K).

[0076] Accordingly, the present technology provides a method for safely disposing of unused sample 500, swab device 200, and sample collection device 100, for example, by minimizing and / or eliminating the risk of exposing the user and / or the environment to pathogens present in the sample 500. For example, the swab device 200 (and unused sample 500) can be sealed inside the sample collection device 100 and disposed of. In some embodiments, disposal of the swab device (200) (and any unused sample (500)) and sample collection device (100) comprises placing the sample collection device (100) (e.g., comprising the swab device (200) and any unused sample (500) sealed within the extraction tube body (110) by the top cap (120) and bottom cap (130)) in a biohazard waste container (999) (e.g., a biohazard waste bag) for safe disposal in accordance with laboratory safety practices. FIG. 1K. In some embodiments, the method further comprises disposal of the analytical assay device (600). In some embodiments, disposal of the analytical assay device (600) comprises placing the analytical assay device (600) in a biohazard waste container (999) (e.g., a biohazard waste bag) for safe disposal in accordance with laboratory safety practices. FIG. 1K. In some embodiments, the sample collection device (100) (e.g., including the swab device (200) and any unused sample (500)) and the analytical assay device are placed in a biohazard waste container (999) (e.g., a biohazard waste bag). In some embodiments, the sample collection device (100) (e.g., including the swab device (200) and any unused sample (500)) and the analytical assay device are each placed in a separate biohazard waste container (999) (e.g., a biohazard waste bag) and disposed of separately.

[0077] Commercially available alternative systems offer some protection against contamination, but do not fully address each of the following criteria: a) reduced sample preparation exposure risk, b) reduced equipment exposure risk, and c) reduced accessory waste risk.

[0078] All publications and patents mentioned in the foregoing specification are incorporated herein by reference in their entirety for all purposes. Various modifications and variations of the described compositions, methods, and uses of the present technology will be apparent to those skilled in the art without departing from the scope and spirit of the described technology. Although the present technology has been described in connection with specific exemplary embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described methods for carrying out the invention that are apparent to those skilled in the art are intended to be within the scope of the following claims.

Claims

1. 1. A sample collection device comprising: an extraction tube body including an upper end, a middle portion, and a lower end; and a swab device received in the extraction tube body, the upper end is configured to receive a top cap; the lower end is configured to receive a bottom cap; and the bottom end includes a dropper feature; the swab device includes a breakable joint, the broken swab device having a length that fits completely within the extraction tube body; the extraction tube body includes a separation component configured to interact with the breakable joint to facilitate breaking the swab device at the breakable joint; Sample collection device.

2. The sample collection device of claim 1 , wherein the swab device has a length greater than the sum of the length of the central portion and the length of the top end.

3. The sample collection device of claim 1 , wherein the extraction tube body includes a fill line.

4. The sample collection device of claim 3 , wherein the fill line indicates a volume of approximately 300 μL.

5. The sample collection device of claim 1 , wherein the swab device is flexible.

6. 6. The sample collection device of claim 5, wherein the swab device is bendable to fit snugly inside the extraction tube body.

7. 10. The sample collection device of claim 1, wherein the extraction tube body includes an upper cap sealing the upper end and a lower cap sealing the lower end, and at least a portion of the swab device is sealed within the extraction tube body.

8. The sample collection device of claim 1 , wherein the extraction tube body includes a top cap sealing the upper end, with the dropper feature exposed.

9. The sample collection device of claim 1 , wherein the dropper feature outputs a droplet of approximately 50 μl.

10. The sample collection device of claim 1 , wherein the sample collection device is made from polyethylene.

11. The sample collection device of claim 1 , wherein the sample collection device is made from high density polyethylene.

12. a) a sample collection device according to any one of claims 1 to 11, wherein the swab device comprises a swab end and a swab handle; b) a buffer solution; A kit comprising:

13. 13. The kit of claim 12, further comprising an analytical assay device.

14. The kit of claim 13 , wherein the analytical assay device is configured to detect a hazardous substance.

15. 15. The kit of claim 14, wherein the hazardous substance is a pathogen.

16. 16. The kit of claim 15, wherein the pathogen is a bacterium or a virus.

17. 13. The kit of claim 12, further comprising a biohazard waste container.

18. A method of operating a sample collection device according to any one of claims 1 to 11, wherein the swab device includes a swab end and a swab handle, the method comprising: a) placing the swab device in contact with a sample into the extraction tube body with the proximal end of the swab handle extending above the upper end of the extraction tube body and the swab end in contact with a buffer solution provided within the extraction tube body; b) the swab end is separated from at least a portion of the swab handle or the swab device is forced into the extraction tube body; c) the top cap is secured to the extraction tube body; d) the bottom cap is removed from the extraction tube body; e) dispensing a buffer solution containing at least a portion of the sample from the dropper feature; A method comprising:

19. 20. The method of claim 18, further comprising performing an analytical assay on the buffer solution comprising at least a portion of the sample.

20. 20. The method of claim 18 or claim 19, wherein the extraction tube body and / or analytical assay device including the swab device is capable of being placed in a biohazard disposal container.

21. The method of any one of claims 18 to 20, comprising separating the swab end from at least a portion of the swab handle by contacting the exterior of the extraction tube body.

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