Diagnostic devices and associated methods and kits

Abstract

The present technology generally relates to medical devices and, in particular, to diagnostic devices and associated methods and kits. In some embodiments, a diagnostic device can include a body, a plurality of test strips, a stem, and a sample collection member. The plurality of test strips, each of which can be configured to test a sample for a respective disease, can be positioned within the body. The stem can have a proximal portion positioned within the body and a distal portion extending distally beyond the body. The sample collection member can be seated about and / or coupled to the distal portion of the stem and configured to collect a test sample from a user. One or more flow channels extending through the body can allow fluid to carry the user sample from the sample collection member into the body and into contact with the plurality of test strips.

Description

DIAGNOSTIC DEVICES AND ASSOCIATED METHODS AND KITSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to U.S. Provisional App. No. 63 / 640,870, filed April 30, 2024, and U.S. Provisional App. No. 63 / 710,502, filed October 22, 2024, both of which are hereby incorporated by reference herein in their entireties.TECHNICAL FIELD

[0002] The present technology generally relates to medical devices and, in particular, to diagnostic devices and associated methods and kits.BACKGROUND

[0003] The worldwide pandemic caused by the spread of COVID-19 continues to impair the quality of life of many individuals and has significant social and economic impacts across the world. Diagnostic testing for infection is central to detecting the virus in persons presenting with and without COVID- 19 symptoms and those who have been in contact with persons exposed to COVID-19 to contain the spread of the virus. Additionally, Influenza has seasonal outbreaks throughout the world with millions of cases and hundreds of thousands of deaths annually. Diagnostic testing will continue to be important as it is expected that COVID-19, Influenza, and other viruses will continue to circulate even with the availability of vaccines. There is a strong need for low-cost, easy to use, accurate tests that can be performed by the person being tested in private and that provides the results quickly. Additionally, many current testing devices are limited to testing for one specific disease and do not account for other diseases that the person being tested might have contracted.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

[0005] FIGS. 1 A and IB are perspective views of a patient testing system configured in accordance with embodiments of the present technology.

[0006] FIG. 2A is a perspective view of a reagent vessel of the patient testing system of FIG. 1A.

[0007] FIG. 2B is a top view of the reagent vessel of FIG. 2A.

[0008] FIG. 2C is a side cross-sectional view of the reagent vessel of FIG. 2A.

[0009] FIG. 2D is another side cross-sectional view of the reagent vessel of FIG. 2A.

[0010] FIG. 3A is a perspective view of a diagnostic device of the patient testing system of FIG. 1A.

[0011] FIG. 3B is a partially exploded perspective view of the diagnostic device of FIG. 3 A.

[0012] FIG. 3C is a cross-sectional top view of the diagnostic device of FIG. 3A.

[0013] FIG. 4 is a flow diagram of a process or method for performing one or more tests on a patient sample using a patient testing system configured in accordance with embodiments of the present technology.

[0014] FIGS. 5A-5G are side views, of which FIGS. 5C and 5D are side cross-sectional views, of the patient testing system of FIGS. 1A and IB during different stages of the method 450, in accordance with embodiments of the present technology.

[0015] FIGS. 6A and 6B are perspective views of a patient testing system configured in accordance with embodiments of the present technology

[0016] FIG. 7A is an exploded perspective view of a reagent vessel of the patient testing system of FIG. 6A

[0017] FIG. 7B is a side cross-sectional view of the reagent vessel of FIG. 7A

[0018] FIG. 8A is a perspective view of a diagnostic device of the patient testing system of FIG. 1A.

[0019] FIG. 8B is an exploded perspective view of the diagnostic device of FIG. 8A

[0020] FIG. 8C is a perspective view of an end of a housing of the diagnostic device of FIG.8A.

[0021] FIG. 8D is a perspective view of an end of a housing and a stem of the diagnostic device of FIG. 8 A.

[0022] FIG. 8E is a perspective cross-sectional view of a housing of the diagnostic device of FIG. 8A taken along section line A-A in FIG. 8A.

[0023] FIG. 8F is a perspective cross-sectional view of the diagnostic device of FIG. 8 A taken along section line A-A in FIG. 8A.

[0024] FIG. 8G is a cross-sectional view of a housing of the diagnostic device of FIG. 8A taken along section line B-B in FIG. 8A.

[0025] FIG. 8H is a cross-sectional view of the diagnostic device of FIG. 8A taken along section line B-B in FIG. 8A.

[0026] FIG. 81 is another cross-sectional view of the housing of the diagnostic device of FIG. 8A.

[0027] FIG. 8J is another cross-sectional view of the diagnostic device of FIG. 8 A.

[0028] FIGS. 9A-9D are side cross-sectional views of the patient testing system of FIGS. 6A and 6B during different stages of a method, in accordance with embodiments of the present technology.DETAILED DESCRIPTION

[0029] The present technology is directed to diagnostic devices and associated methods and kits. In some embodiments, the diagnostic devices of the present technology contain one or more tests strips (e.g., lateral flow immunoassay (LFA) test strips), such as a first test strip for a first disease such as COVID-19, a second test strip for a second disease such as Influenza A, and a third test strip for a third disease such as Influenza B. The test strips included in a given diagnostic device can be exchanged or replaced with one or more other test strips configured to test for a same or different disease, as needed. Each of the test strips included in a given diagnostic device can be configured to test a respective portion of a (e.g., single, same) sample collected from a patient. Each of the test strips can be configured to test for a single disease or multiple diseases. At least some of the diagnosticdevices configured in accordance with embodiments of the present technology can improve accessibility to disease diagnostic technology by, for example, including large clear labelling and / or easy-to-hold and use components, and / or by being configured to be operated in simple and easy-to- perform steps to obtain multiple test results.

[0030] The present technology provides low-cost, reliable diagnostic devices suitable for use in a private setting (e.g., in the patient’s home) as well as in laboratories, doctor’s offices, clinics, schools, airports, restaurants, and / or other point of care and / or high traffic public settings. The diagnostic devices of the present technology can be sufficiently simple and easy to use such that laypersons (e.g., the patient undergoing testing) can perform diagnostic testing without assistance from a healthcare professional. Additionally, the devices described herein are expected to be low-cost and suitable for mass distribution to large numbers of consumers, thus allowing for large-scale, rapid testing for infectious diseases (e.g., COVID-19, Flu A, Flu B, etc.) and / or other conditions. In some embodiments, the devices and methods described herein use antigen-based tests, which can provide faster results compared to other types of tests (e.g., PCR tests). Accordingly, the patient can quickly determine whether they are positive and can take immediate action to limit the spread of infection (e.g., quarantine) and / or seek treatment.

[0031] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to FIGS. 1A-9D.

[0032] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0033] FIGS. 1 A and IB are perspective views of a patient testing system 100 (“system 100”) configured in accordance with embodiments of the present technology. The system 100 can include a reagent vessel 104 and a diagnostic device 102. In FIG. 1A, the system 100 is shown with at least a portion of the diagnostic device 102 received by (e.g., docked with) the reagent vessel 104. In FIG. IB, the system 100 is shown with the diagnostic device 102 and the reagent vessel 104 spaced apart from one another.

[0034] The diagnostic device 102 can include a tip portion 108 (e.g., a distal tip portion) configured to collect a sample from a patient or other user for testing. In at least some embodiments, for example, the patient can insert the tip portion 108 into one or both nostrils and manipulate (e.g., rotate, swab, etc.) the diagnostic device 102 to collect a sample with the tip portion 108. The reagent vessel 104 can define an interior area or chamber 106 that is configured to contain fluid (e.g., reagent or buffer) and receive at least a portion of the diagnostic device 102. In the illustrated embodiment, for example, the tip portion 108 can be configured to be received within the chamber 106. As described in greater detail below, inserting (e.g., fully inserting) the tip portion 108 into the chamber 106 and, e.g., into contact with the fluid contained therein, can initiate or otherwise cause one or more tests to be performed on the patient sample collected by the diagnostic device 102.

[0035] FIG. 2A is a perspective view of the reagent vessel 104 of the system 100. The reagent vessel 104 can include a body 210 having a first or proximal end portion 212a and a second or distal end portion 212b spaced from the first end portion 212a along a longitudinal and / or vertical axis of the body 210. The first end portion 212a can define an opening 214 to the chamber 106 and the opening 214 can be sized and / or otherwise configured to facilitate inserting at least a portion of the diagnostic device 102 (FIGS. 1A and IB) into the chamber 106. The second end portion 212b can be at least generally flat or planar and / or otherwise configured to rest on a support surface, e.g., a table top, a countertop, a lab bench, and / or one or more other suitable support surfaces. In at least some embodiments, the first end portion 212a and the second end portion 212b can each include or otherwise define a respective terminal end or surface of the body 210. For example, the first end portion 212a can include or define a first or proximal -most end or surface of the body 210 and the second end portion 212b can include or define a second or distal-most end or surface of the body 210.

[0036] The first end portion 212a can have a first dimension DI (e.g., a first diameter, a first width, a first perimeter, one or more other suitable dimensions, and / or combinations thereof) and thesecond end portion 212b can have a second dimension D2 (e.g., a second diameter, a second width, a second perimeter, one or more other suitable dimensions, and / or combinations thereof). In the illustrated embodiment, the first dimension DI is greater than the second dimension D2 such that, e.g., the body 210 is sloped / tapered inwardly from the second end portion 212b toward and / or to the first end portion 212a. The first dimension DI being greater than the second dimension D2 is expected to increase the stability of the reagent vessel 104 and / or otherwise reduce the risk that the reagent vessel 104 is tipped over when, e.g., the reagent vessel 104 is in use and / or the diagnostic device 102 is docked with the reagent vessel 104. In other embodiments, however, the second dimension D2 can be greater than or equal to the first dimension DI .

[0037] FIG. 2B is a top view of the reagent vessel 104. The reagent vessel 104 can further include a barrier or seal 218 positioned within the chamber 106. In the illustrated embodiment, for example, the seal 218 is above the fluid within the chamber 106, e.g., between the fluid and the opening 214. The seal 218 can be at least substantially fluid-impermeable and, accordingly, can be configured to retain the fluid within the chamber 106 and / or inhibit, or even prevent, foreign matter (e.g., debris, contaminants, outside air, etc.) from mixing with the fluid until, e.g., the seal 218 is broken by a user. The seal 218 can be frangible, removable, and / or otherwise configured to selectively control access to the fluid within the chamber 106. In at least some embodiments, the force required to break the seal 218 is sufficiently high enough for the seal 218 to be durable and resist inadvertent punctures but sufficiently low enough to easily broken by a young, old, or infirm user.

[0038] FIG. 2C is a side cross-sectional view of the reagent vessel 104. As best shown in FIG. 2C, the seal 218 can divide the chamber 106 into one or more chamber portions 220. In the illustrated embodiment, for example, the seal 218 divides the chamber 106 into a first or upper chamber portion 220a and a second or lower chamber portion 220b. The first chamber portion 220a can include the spillways 216 and / or be open to the surrounding environment. The second chamber portion 220b can include fluid 222 (e.g., reagent, test solution, etc.) and be protected by the seal 218, e.g., unless or until the seal 218 is broken.

[0039] FIG. 2D is another side cross-sectional view of the reagent vessel 104. The reagent vessel 104 is rotated 90 degrees in FIG. 2D relative to FIG. 2C. In some embodiments, the body 210 can define one or more spillways 216 (one labeled in FIG. 2D, others labelled in FIGS. 2A and 2C) and one or more spill chambers 224. Each of the spillways 216 can include an opening positionedwithin the chamber 106, e.g., the first chamber portion 220a. Each of the spill chambers 224 can be configured to receive fluid via one or more of the spillways 216. If or when the reagent vessel 104 is tipped or knocked over, the spillways 216 can be configured to direct the fluid 222 into one or more of the spill chambers 224, e.g., minimizing or even preventing fluid spillage through the opening 214. Accordingly, the spillways 216 and the spill chambers 224 can, together, prevent, or at least partially prevent, the fluid contained within the chamber 106 from spilling through the chamber opening 214 if, e.g., the reagent vessel 104 is tipped over while in use. If, for example, the reagent vessel 104 is tipped or knocked over after the seal 218 is or has been broken, the fluid 222 within the chamber 106 can flow through the spillways 216 and into the spill chamber(s) 224 as shown by arrow F, e.g., instead of passing through the opening 214 and / or out from the chamber 106. Put differently, the fluid 222 can preferentially flow into the spill chamber(s) 224 instead of, e.g., spilling out through the chamber opening 214. For example, at least 50%, 60%, 70% 80%, 90%, or 99% flows into the spill chamber(s) 224 instead of spilling out through the chamber opening 214. In the illustrated embodiment, the body 210 defines a single spill chamber 224 extending annularly around at least a portion of the chamber 106 and configured to receive fluid via each of the spillways 216. In other embodiments, the body 210 can define two, three, four, or more spill chambers 224, each of which can be configured to receive fluid via at least one, two, three, or more of the spillways 216.

[0040] FIG. 3 A is a perspective view of the diagnostic device 102. The diagnostic device 102 can include a body or housing 326, a cap 325, and the tip portion 108. The housing 326 can include one or more side portions 328 (individually identified as a first side portion 328a, a second side portion 328b, and a third side portion 328c). In the illustrated embodiment, each of the three side portions 328a-c contact the other of the three side portions 328a-c at a respective rounded corner. In these and / or other embodiments, all or a subset of the side portions 328 can contact one or more of the other side portions 328 at an edge, such as an edge that defines an interior angle of up to 10 degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100 degrees, 120 degrees, any angle therebetween and / or one or more combinations thereof. The rounded triangular shape of the housing 326 shown in FIG. 3A is expected to be easy and / or comfortable for a wide range of users to hold and / or manipulate. In other embodiments, however, the housing 326 can have four, five, six, seven, or more sides and still retain one or more of these advantageous properties.

[0041] All or a subset of the side portions 328 can include a respective view port or window 330, identifier 334, and / or test interpretation indicia 336. Each window 330 can be configured to allow a user to visualize an interior portion of the diagnostic device 102 including, e.g., a test strip 332 positioned therein. For example, each window 330 can include an at least generally transparent portion of the housing 326, an at least generally transparent element (e.g., glass, polymers, and / or combinations thereof) coupled to the housing 326, and / or an opening or aperture through the housing 326. In the illustrated embodiment, each of the three side portions 328a-c includes a corresponding window 330 (individually identified as first window 330a and second window 330b; third window 330c is obscured from view in FIG. 3A) configured to allow the user to visualize an associated test strip 332 (only first test strip 332a is shown in FIG. 3A).

[0042] Each identifier 334 can be located adjacent and / or proximate to (e.g., within 5 mm, 4 mm, 3 mm, 2 mm, or 1 mm of) one of the windows 330 and can include text (e.g., printed text, embossed text, debossed text, and / or combinations thereof), a printed label, a bar code, a QR code, and / or other human- and / or machine-readable indicia configured to provide information to the user about the configuration of a corresponding one of the test strips 332 visible through a given one the windows 330. In the illustrated embodiment, each of the three side portions 328a-c includes a respective identifier 334 (individually identified as a first identifier 334a and a second identifier 334b; third identifier 334c is obscured from view in FIG. 3A) associated with the disease or other condition (e.g., “COVID”, “FLU A”, “FLUB,” etc.) that the test strip 332 on the same side portion is configured to detect. The text, characters, etc., included in the identifiers 334 can be printed in one or more easily- readable colors and / or a generally large font size, such as a font size of at least lOpt, 12pt, 14pt, 16pt, 18pt, 20pt, or greater, which is expected to improve (e.g., further improve) the accessibility of the diagnostic device 102.

[0043] The test interpretation indicia 336 can be configured to provide instructions to, e.g., the user for interpreting results (e.g., a control indicator “C” and / or a test result indicator “T”) of a test performed by a corresponding one of the test strips 332. In the illustrated embodiment, each of the three side portions 328a-c includes and respective test interpretation indicia 336 (identified as first test interpretation indicia 336a; second and third test interpretation indicia 336b, 336c are obscured from view in FIG. 3A) for the test strip 332 visible through the window 330 on a given side portion 328. In other embodiments, one or more of the side portions 328 can omit the window 330, theidentifi er 334, and / or the test interpretation indicia 336. The text, characters, etc., included in the test interpretation indicia 336 can be printed in one or more easily-readable colors and / or a generally large easily-readable font size, such as a font size of at least lOpt, 12pt, 14pt, 16pt, 18pt, 20pt, or greater, which is expected to improve (e.g., further improve) the accessibility of the diagnostic device 102.

[0044] The tip portion 108 can include a stem 338 extending (e.g., distally) from the housing 326 and a sample collection member or swab 340 coupled to the stem 338 (e g., a distal portion of the stem 338). The swab 340 can include foam and / or otherwise be configured to collect a test sample from, e.g., a user. In some embodiments, the swab 340 is releasably coupled to the stem 338 and, accordingly, can be replaced with swabs 340 of different sizes and / or an unused swab after sample collection. The stem 338 can be configured to direct at least a portion of the test sample from the swab 340 to the test strips 332 contained within the housing 326. In some embodiments, a distal portion 329 of the housing 326 can taper inwardly (e.g., radially inwardly) toward and / or to the stem 338.

[0045] FIG. 3B is a partially exploded perspective view of the diagnostic device 102. As best shown in FIG. 3B, the diagnostic device 102 can include one or more test strip holders 342 (individually identified as a first test strip holder 342a, a second test strip holder 342b, and a third test strip holder 342c). Applying too great a force (e.g., compressive, tensile, torsional, shear, and / or bending forces) to the test strips 332 can inhibit or even prevent the test strips 332 from operating as intended, e.g., by decreasing the absorptivity of the test strips 332 and thereby decreasing their ability to receive quantities of the fluid and sample sufficient for accurate testing. To reduce or even prevent the application of such forces to the test strips 332, each of the test strips 332 (individually identified as a first test strip 332a, a second test strip 332b, and a third test strip 332c) can be positioned within a corresponding one of the test strip holders 342 , e.g., so as to support the test strips 332 within the housing 326. The cap 325 can be configured to engage the housing 326 to, e.g., retain the test strips 332 and / or the test strip holders 342 within the housing 326. In at least some embodiments, the cap 325 is removable to allow the user to replace used test strips with unused and / or other test strips. For example, one or more of the test strips 332 can be exchanged or replaced with one or more other test strips configured to test for a same or different disease, as needed. In one particular example, the ability to exchange or replace one or more of the test strips 332 allows individual ones of the test strips 332 to be replaced with other test strips that, e.g., include more sensitive testing antibodies for a same or different disease, are configured to test for new variants of existing diseases, are configuredto test for new or emerging diseases, and / or combinations thereof. In at least some embodiments, one or more of the test strips 332 can be exchanged or replaced without changing one or more of the other test strips 332 in the diagnostic device 102. This is expected to make it easier to adjust the testing capabilities of the diagnostic device 102 compared to, e.g., other devices that include a single “multiplexed” test strip configured to test for multiple diseases. Although the embodiment illustrated in FIG. 3B includes three test strip holders 342, in other embodiments the diagnostic device 102 can include at least two, four, five, six, seven, eight, nine, ten, or more test strip holders 342, each of which can be configured to receive at least one, two, three, four, five, or more test strips.

[0046] The stem 338 can define one or more openings or ports 344. Each of the ports 344 can be configured to provide access (e g., fluid access) to the interior of the housing 326 and one or more of the test strips 332 contained therein. The swab 340, when coupled to the stem 338, can be seated over all or a subset of the ports 344. Referring additionally to FIG. 3C, which is a cross-sectional plan view of the diagnostic device 102, the stem 338 can define a fluid path 346 that extends from the one or more ports 344 to an interior 327 of the housing 326. Once a predetermined amount of fluid (from, e.g., the reagent vessel 104) has entered the interior 327, the fluid can interact with (e.g., wet) all or a subset of the test strips 332 contained within the interior 327. In some embodiments, one or more of the test strip holders 342 include one or more ports or fluid openings 343 and, once the fluid has filled the interior 327 to the level of the fluid openings 343, the fluid an enter the test strip holders 342 via the fluid openings 343 to, e.g., wet the test strips 332 contained therein. In some embodiments, the interior 327 can include one or more posts or support members 331 (individually identified as first, second, and third posts 331a-c) configured to contact one or more of the test strip holders 342 to seat the test strip holders 342 within the interior 327. In some embodiments, the interior 327 can include one or more spacers 333 (individually identified as first, second, and third spacers 333a-c) that define slots therebetween configured to receive corresponding one of the test strips 332 and / or the test strip holders 342, e.g., in a spaced apart relation to one another. In the illustrated embodiment, for example, the spacers 333 and corresponding portions of the housing 326 surround at least three sides of the test strips 332 and / or the test strip holders 342 but a fourth side at least partially open to face toward the longitudinal axis and / or the fluid path 346, e.g., to facilitate hydration of the test strips 332. In at least some embodiments, the spacers 333 can be configured to maintain, or at least generally maintain, a position of the test strips 332 and / or the test strip holders 342 relative to a longitudinal axis of thehousing 326, and / or other prevent, or at least partially prevent, the test strips 332 and / or the test strip holders 342 from moving within the interior 327 of the housing 326.

[0047] FIG. 4 is a flow diagram of a process or method 450 for performing one or more tests on a patient sample using a patient testing system configured in accordance with embodiments of the present technology. Although some features of the method 450 are described in the context of the system 100 shown in FIGS. 1A and IB for illustration, one skilled in the art will readily understand that the method 450 can be carried out using other suitable systems and / or devices described herein, including those described with reference to FIGS. 6A-9D. FIGS. 5A-5G are side views, of which FIGS. 5C and 5D are side cross-sectional views, of the system 100 of FIGS. 1A and IB during different stages of the method 450, in accordance with embodiments of the present technology. Individual ones of FIGS. 5A-5G are described below with reference to a one or more blocks 452- 458 of the method 450.

[0048] At block 452, the method 450 can include receiving, at a diagnostic device of a patient testing system, a sample from a patient. For example, FIG. 5A shows a user U using the diagnostic device 102 to obtain a sample. To obtain the sample, the user U can, for example, insert the swab 340 into one or both of their nostrils N, such that the sample is received on, obtained by, and / or otherwise collected via the swab 340.

[0049] At block 454, the method 450 can include receiving the sample within a reagent vessel of the patient testing system. Receiving the sample can include receiving at least a portion of the diagnostic device within the reagent vessel. For example, FIG. 5B shows the diagnostic device 102 being inserting into the reagent vessel 104. Inserting the diagnostic device 102 into the reagent vessel 104 can include advancing the diagnostic device 102 toward and / or into the chamber 106 of the reagent vessel 104 with the swab 340 leading other portions of the diagnostic device 102. Inserting the swab 340 into the chamber 106 can, accordingly, cause the sample on the swab 340 to be received within the reagent vessel 104.

[0050] At block 456, the method 450 can include causing one or more tests to be performed on the sample. Causing the one or more tests to be performed can include introducing the sample into a test solution contained within the reagent vessel. For example, FIG. 5C shows the swab 340 being advanced into contact with (e.g., downwardly into contact with) the seal 218. The user can continue to move the swab 340 in this direction and cause the swab 340 to pierce the seal 218 and introducethe swab 340 (and, e.g., the sample contained therein and / or thereon) into the fluid 222 within the reagent vessel 104. This is shown, for example, in FIG. 5D. Referring to FIG. 5D, as the swab 340 comes into contact with the fluid 222, the fluid 222 can hydrate the swab 340 (and, e.g., the sample contained therein and / or thereon), flow into the stem 338 via one or more of the ports 344, and enter the housing 326 of the diagnostic device 102 via the stem 338. The fluid 222 can flow and / or be caused to move upwardly and / or vertically through the stem 338 and / or into the housing 326. Once in the housing 326, the fluid 222 can hydrate one or more of the test strips 332 contained therein. The fluid 222 can be configured to carry respective portions of the sample (e.g., a first sample portion, a second sample portion, a third sample portion, etc.) from the swab 340 to the one or more test strips 332, such as shown by the arrows in FIG. 5D. Accordingly, hydrating the one or more test strips 332 with the fluid 222 can introduce respective portions of the sample to each of the one or more test strips 332 to activate the one or more test strips 332 can cause them to each perform a respective test on the received portion of the sample. As described previously herein, the diagnostic device 102 can include a plurality of test strips and, accordingly, causing the one or more tests to be performed on the sample can include causing a plurality of tests to be performed on the sample. In at least some embodiments, for example, block 456 can include causing as many tests to be performed as there are test strips in the diagnostic device.

[0051] At block 458, the method 450 can include displaying, via the diagnostic device, results of the one or more tests. In some embodiments, the diagnostic device includes a plurality of test strips, each configured to perform a different test on a sample and, accordingly, displaying the results can include displaying, via the plurality of test strips, the results of the tests performed by the plurality of test strips. For example, FIGS. 5E-5G are views of the sides 328a-c, respectively, of the diagnostic device 102. To obtain the results from the one or more tests, the user can observe one of the test strips 332a-c through a corresponding one of the windows 330a-c on a given one of the sides 328a-c and evaluate that test strip 332a-c against the corresponding test interpretation indicia 336a-c. The identifiers 334a-c on each of the sides 328a-c are associated with the configuration of the test strip 332a-c that is observable through the window 330a-c on the same side 328a-c. In the illustrated embodiment, the first window 330a displays a result from a test for COVID-19, the second window 330b displays a result from a test for Influenza A, and the third window 330c displays a result from a test for Influenza B. More specifically, a comparison of the first test strip 332a and the first test interpretation indicia indicates 336a in FIG. 5E shows that the user has tested positive for CO VID,whereas a comparison of the second and third test strips 332b, 332c and the second and third test interpretation indicia 336b, 336c in FIGS. 5F and 5G shows that the user has, respectively, tested negative for Influenza A and B. In some embodiments, obtaining the results from these and / or other tests includes waiting a predetermined amount of time (e.g., up to 5, 10, 15, 20, 25, 30, or more minutes) before obtaining one or more of the test results.

[0052] FIGS. 6A and 6B are perspective views of a patient testing system 600 (“system 600”) configured in accordance with embodiments of the present technology. At least some aspects of the system 600 can be at least generally similar or identical in structure and / or function to one or more aspects of the system 100 described previously herein, including with reference to FIGS. 1A-5G. For example, the system 600 can include a reagent vessel 604 and a diagnostic device 602. In FIG. 6A the system 600 is shown with at least a portion of the diagnostic device 602 received by (e.g., docked with) the reagent vessel 604. In FIG. 6B the system 600 is shown with the diagnostic device 602 and the reagent vessel 604 spaced apart from one another.

[0053] The diagnostic device 602 can include a tip portion 608 (e.g., a distal tip portion) configured to collect a sample from a patient (or other user) for testing. In at least some embodiments, for example, the patient can insert the tip portion 608 into one or both nostrils and manipulate (e.g., rotate, swab, etc.) the diagnostic device 602 to collect a sample with the tip portion 608. The reagent vessel 604 can define an interior area or chamber 606 that is configured to contain fluid (e g., reagent or buffer) and receive at least a portion of the diagnostic device 602. In the illustrated embodiment, for example, the tip portion 608 can be configured to be received within the chamber 606. As described in greater detail below, inserting (e.g., fully inserting) the tip portion 608 into the chamber 606 and, e.g., into contact with the fluid contained therein, can initiate or otherwise cause one or more tests to be performed on the patient sample collected by the diagnostic device 602.

[0054] FIG. 7A is an exploded perspective view of the reagent vessel 604. Compared to the reagent vessel 104 (FIGS. 1 A-2D), the reagent vessel 604 can include multiple different components or pieces. In the illustrated embodiment, for example, the reagent vessel 604 includes a body 710 and a fluid reservoir 760 configured to be coupled to the body 710. The body 710 can have a first or proximal end portion 712a and a second or distal end portion 712b spaced from the first end portion 712a along a longitudinal and / or vertical axis of the body 710. The first end portion 712a can define an opening 714 to the chamber 606 and the opening 714 can be sized and / or otherwise configured tofacilitate inserting at least a portion (e.g., the tip portion 608) of the diagnostic device 602 (FIGS. 6A and 6B) into the chamber 606. The second end portion 712b can be at least generally flat or planar and / or otherwise configured to rest on a support surface, e.g., a table top, a countertop, a lab bench, and / or one or more other suitable support surfaces.

[0055] The fluid reservoir 760 can be configured to contain a fluid (e.g., reagent or buffer). The fluid can be at least generally similar or identical to the fluid 222 (FIGS. 2C and 2D) and can be configured to facilitate the performance of one or more tests on a patient sample, e.g., collected by the diagnostic device 602 (FIGS. 6A and 6B). The volume of fluid contained within the fluid reservoir 760 can be up to 100 microliters (pL), 200 pL, 250 pL, 300 pL, 350 pL, 400 pL, 500 pL, 550 pL, 600 pL, 650 pL, 700 pL, 750 pL, 800 pL, 850 pL, 900 pL, 950 pL, or 1 milliliter (mL). Without being bound by theory, including a volume of the fluid within the fluid reservoir 760 that is less than 1 mL (e.g., 550 pL) is expected to increase the testing sensitivity of the diagnostic device 602, e.g., by reducing the degree to which a patient sample is diluted by the fluid within the fluid reservoir 760. The fluid can be sealed within the fluid reservoir 760 by a seal 718, e.g., a frangible seal, which can be at least generally similar to the seal 218 of FIG. 2B. In some embodiments, the fluid reservoir 760 can define a mounting surface 762 (e.g., a recessed mounting surface) configured to receive or seat a corresponding sealing element 764, such as an O-ring.

[0056] FIG. 7B is a side cross-sectional view of the reagent vessel 604 of FIG. 7A. The fluid reservoir 760 can be configured to be coupled to the body 710, e.g., with the body 710 serving as a covering, shroud, or support for the fluid reservoir 760. For example, the fluid reservoir 760 can include or define one or more first mating features 766, the body 710 can include or define one or more second mating features 768, and the one or more first mating features 766 can be configured to correspond to the one or more second mating features 768 to facilitate coupling (e.g., releasably coupling) the fluid reservoir 760 to the body 710. In the illustrated embodiment, the one or more first mating features 766 include helical threading and the one or more second mating features 768 include a helical groove configured to releasably receive the helical threading to couple to fluid reservoir 760 to the body 710. In other embodiments, the one or more first mating features 766 can include the helical groove and the one or more second mating features 768 can include the helical threading. In these and / or other embodiments, the one or more first mating features 766 and / or the one or more second mating features 768 can include other suitable features (e.g., protrusions, recesses, snap-fitfeatures, male and / or female bayonet connectors, adhesives, pins, and / or combinations thereof) configured to facilitate coupling the fluid reservoir 760 to the body 710. The body 710 and / or the fluid reservoir 760 can, in at least some embodiments, be single use or reusable, and the ability to couple and decouple these component as needed can facilitate their use, disposal, and / or reuse.

[0057] As best seen in FIG. 7B, the body 710 can include an outer portion 710a, an inner portion 710c, and an intermediate portion 710b positioned between (e.g., radially between) the outer portion 710a and the inner portion 710c. The outer portion 710a can be configured to rest on a support surface, such as a table, countertop, or lab bench, and can be configured to extend around (e.g., annularly around) all or at least a portion of a first circumference of the fluid reservoir 760. The intermediate portion 710b can include and / or define the one or more second mating features 768 and, in at least some embodiments, can be configured to suspend the fluid reservoir 760 from the body 710 when the fluid reservoir 760 is coupled thereto. In the illustrated embodiment, for example, the fluid reservoir 760 is held with its distalmost end located proximally from a distalmost end of the body 710, e.g., such that the body 710, but not the fluid reservoir 760, would contact a planar or at least generally planar surface when the second end portion 712b of the reagent vessel 604 is placed thereon. In some aspects, suspending the fluid reservoir 760 from the body 710 as described previously is expected to improve the stability of the reagent vessel 604 while in use and / or under circumstances in which the surfaces used to support the reagent vessel 604 may have irregularities and / or might otherwise not be planar or near-planar. When the fluid reservoir 760 is coupled to the body 710, the sealing element 764 can sealing engage the intermediate portion 710b, e.g., to form a substantially fluid- impermeable seal therewith to prevent, or at least partially prevent, fluid spillage from between the fluid reservoir 760 and the body 710.

[0058] The inner portion 710c can have a distal or distalmost end 770 configured to face toward and / or contact a proximal or proximal-most end 772 of the fluid reservoir 760, e.g., including when the fluid reservoir 760 is coupled to the body 710. The seal 718 can be coupled to the proximal end 772 of the fluid reservoir 760 and / or positioned at least partially between the distal end 770 and the proximal end 772. In some embodiments, only the seal 718 is between the distal end 770 and the proximal end 772. The inner portion 710c can further define a docking feature 774 which, as described in greater detail below, can be configured to facilitate docking the diagnostic device 602 with the reagent vessel 604. When the sealing element 764 is positioned about the fluid reservoir 760, thesealing element 764 can be positioned below the one or more first mating features 766, e.g., with the one or more first mating features 766 located between the sealing element 764 and the distal end 770.

[0059] In some embodiments, the body 710 can define a first or upper chamber portion 720a and the fluid reservoir 760 can define a second or lower chamber portion 720b and, when the body 710 and the fluid reservoir 760 are coupled, the first and second chamber portions 720a, 720b can together define the chamber 606. The seal 718 can be positioned between the first and second chamber portions 720a, 720b and, accordingly, can be configured to retain the fluid within the second chamber portion 720b and / or inhibit, or even prevent, external objects and / or other material from mixing with the fluid until, e.g., the seal 218 is broken by a user.

[0060] FIG. 8A is a perspective view of a diagnostic device of the patient testing system of FIG. 1 A. FIG. 8B is an exploded perspective view of the diagnostic device 602 of FIG. 8A. Referring to FIGS. 8A and 8B together, the diagnostic device 602 can include a body or housing 826, a cap 825, and the tip portion 608. The housing 826 can include one or more side portions 828 (individually identified as first, second, and third side portions 828a-c, respectively). All or a subset of the side portions 828 can include a respective view port or window 830 (individually identified as first, second, and third windows 830a-c, respectively) and / or identifier 834 (individually identified as first, second, and third identifiers 834a-c, respectively), all or a subset of which can be at least generally similar or identical to the correspondingly named and / or numbered feature described previously herein (e.g., first window 830a and the first window 330a of FIG. 3 A, second identifier 834b and the second identifier 334b of FIG. 3A, etc.). Additionally, although not shown in the embodiment illustrated in FIG. 8A, in other embodiments, the diagnostic device 602 can one or more test interpretation indicia that are at least generally similar or identical to the test interpretation indicia 336 (FIG. 3A).

[0061] The tip portion 608 can include a stem 838 extending (e.g., distally) from the housing 826 and a sample collection member or swab 840 coupled to and / or carried by the stem 838 (e.g., a distal portion of the stem 838). The swab 840 can include foam and / or otherwise be configured to collect a test sample from, e.g., a user. In some embodiments, the stem 838 is releasably coupled to the housing 826 and / or the swab 840 is releasably coupled to the stem 838, e.g., such that the stem 838 and / or the swab 840 can be replaced with stems 838 and / or swabs 840 of different sizes and / or an unused swab after sample collection. In some embodiments, the housing 826 includes a flared orwidened distal end portion 829 of that tapers inwardly (e g., radially inwardly) toward and / or to the stem 838.

[0062] As best seen in FIG. 8B, the stem 838 can have a proximal portion 878a and a distal portion 878b. When the stem 838 is coupled to the housing 826, all or at least a portion of the proximal portion 878a can be positioned within the housing 826 (e.g., via a distal port 882 through the housing 826 configured to permit access to an interior thereof) and all or at least a portion of the distal portion 878b can be positioned external to and / or extend distally from the housing 826. The proximal portion 878a can include a flexible prong 880 or other coupling feature configured to couple the stem 838 to the housing 826, e g., when positioned therein. The distal portion 878b can be configured to receive the swab 840 thereon and / or therearound, e g., so as to support the swab 840 at a location distal to the housing 826. The stem 838 can include a step 888 positioned at least partially between the proximal portion 878a and the distal portion 878b and configured to abut the housing 826 when the stem 838 is coupled thereto. In at least some embodiments, the step 888 can work together with the prong 880 (FIG. 8B) to limit or even prevent the stem 838 from moving relative to the housing 826 when coupled thereto. For example, at least a portion of the housing 826 can be positioned between the step 888 and the prong 880 to couple the stem 838 to the housing 826. In the illustrated embodiment the stem 838 is not hollow and / or does not contain any flow channels extending therethrough, which increases the volume of the stem 838 and, by extension, is expected to allow the stem 838 to drive fluid into the interior of the housing 826 via displacement, in addition to or instead of via capillary action.

[0063] In some embodiments, the diagnostic device 602 includes a sealing element 876, such as an O-ring. The sealing element 876 can be seated about a mounting surface 881 of the housing 826. The mounting surface 881 can be positioned proximally from and / or radially inwardly recessed relative to the distal end portion 829 of the housing. The sealing element 876 can be configured to sealing engage the reagent vessel 604 (FIGS. 6A-7B) when docked therewith and, in at least some embodiments, can facilitate the fluid displacement-based transfer of fluid into the housing described above with reference to the stem 838.

[0064] The diagnostic device 602 can further include one or more test strips 832 (individually identified as first, second, and third test strips 832a-c) and a test strip carrier or holder 842. All or a subset of the test strips 832 can be at least generally similar or identical in structure and / or function to one or more of the test strips 332 (FIGS. 3A-3C). The test strip holder 842 can be configured tosupport the test strips 832 (e.g., all of the test strips 832) within the housing 826. In the illustrated embodiment, for example, the test strip holder 842 has multiple (e.g., three) sides and one or more sets of test strip coupling features 884 (one set identified in FIG. 8B) on each side. Each set of the test strip coupling features 884 can be configured to couple a corresponding one of the test strips 832 to the test strip holder 842. The illustrated test strip coupling features 884 include two sets of opposing tabs, but in other embodiments the test strip coupling features 884 can include staggered tabs, apertures, slots, and / or other suitable coupling features. In some embodiments, one or more sides of the test strip holder 842 can be left blank, e.g., omit a test strip and / or all or a subset of the test strip coupling features 884. The test strip holder 842 can allow one or more of the test strips 832 to be quickly and easily replaced, e.g., with one or more other test strips configured to test for a same or different disease, as needed. As described previously herein, the ability to exchange or replace one or more of the test strips 832 allows individual ones of the test strips 832 to be replaced with other test strips that, e.g., include more sensitive testing antibodies for a same or different disease, are configured to test for new variants of existing diseases, are configured to test for new or emerging diseases, and / or combinations thereof. In at least some embodiments, one or more of the test strips 832 can be exchanged or replaced without changing one or more of the other test strips 832 in the diagnostic device 602. This is expected to make it easier to adjust the testing capabilities of the diagnostic device 602 compared to, e.g., other devices that include a single test strip configured to test for multiple diseases.

[0065] In some embodiments, one or more of the test strip coupling features 884 can be paired with a corresponding backstop 886. In the illustrated embodiment, for example, the backstop 886 extends outwardly (e.g., radially outwardly, perpendicularly outwardly, etc.) from one or more other portions of the test strip holder 842 at a location proximal to the test strip coupling features 884. When one of the test strips 832 (e.g., the first test strip 832a) is coupled to the test strip coupling features 884, the backstop 886 can contact a proximal-most end or terminus of that test strip 832, e.g., to inhibit or even prevent the test strip 832 from sliding or otherwise moving proximally beyond the backstop 886.

[0066] FIG. 8C is a perspective view of a distal end of the housing 826. As best seen in FIG. 8C, the housing 826 can define one or more flow channels 844 (individually identified as first, second, and third flow channels 844 a-c, respectively) configured to allow fluid, such as the fluid containedwithin the reagent vessel, to enter the interior of the housing 826. One or more of the flow channels 844 can be defined at least partially by an angled or sloped distal surface 890a (identified only with respect to the third flow channel 844c for illustrative clarity) and an elongate or planar proximal surface 890b (identified only with respect to the third flow channel 844c for illustrative clarity). Each of the angled surfaces 890a can extend inwardly (e.g., radially inwardly) and / or proximally, e.g., from a distal end of the housing 826. Each of the planar surfaces 890b can extend proximally from the sloped distal surface 890b. These surfaces 890a, 890b can also at least partially define the distal port 882 that is configured to receive the stem 838 (FIG. 8B) but can be located radially outwardly from other interior wall portions that also define the distal port 882. Accordingly, when the stem 838 is received within the distal port 882, the surfaces 890a, 890b can be spaced apart from the stem 838 to allow fluid flow through the flow channels 844, e.g., between the stem 838 and the surfaces 890a, 890b. In the illustrated embodiment, the flow channels 844 are distributed circumferentially around the port 882 at locations that are aligned upstream from a corresponding one of the test strips 832 (FIG. 8B), e.g., to facilitate fluid flow to the test strips 832 via the flow channels 844.

[0067] FIG. 8D is a perspective view of the distal end of the housing 826 and the stem 838. As described previously with reference to FIG. 8C, when the stem 838 is positioned through the port 882 and / or otherwise coupled to the housing 826, the flow channels 844 can remain open to allow fluid to flow into the interior of the housing 826 via the flow channels 844. When the swab 840 (FIG. 8A) is seated about the stem 838, the flow channels 884 can permit fluid (e.g., from the reagent vessel 604, FIGS. 6A-7B) to carry portions of a patient sample collected by the swab 840 through individual ones of the flow channels 884 into the housing 826 and into contact with one or more of the test strips 832 (FIG. 8B) contained therein, e.g., to facilitate testing the patient sample for one or more diseases.

[0068] FIG. 8E is a perspective, cross-section view of the housing 826 taken along section line A-A in FIG. 8A. FIG. 8F is a perspective, cross-section view of the diagnostic device 602 taken along section line A-A. Referring to FIGS. 8E and 8F together, the housing 826 can define one or more radially-outward recesses or pockets 892 (only third pocket 892c is identified), each of which can be configured to receive at least a portion of a corresponding one of the test strips, e.g., with the test strips spaced from the housing 826 and / or the stem 838 to reduce or prevent forces (e.g., compressive forces, tensile forces, torsional forces, shear forces, bending forces and / or combinations thereof) onthe test strips from other portions of the diagnostic device 602. In at least some embodiments, the pockets 892 can be configured to accommodate the test strips 832 within the housing 826 without (or at least substantially without) bending or deforming the test strips 832. For example, as shown in FIG. 8F, the third pocket 892c can receive a proximal portion of the third test strip 832c with the third test strip 832c unbent (or at least substantially unbent) and spaced apart from the housing 826 and / or the stem 838. Each of the pockets 892 can be aligned with a corresponding one of the flow channels 844 so that any fluid that flows through the flow channels 844 can be directed toward and / or onto the test strip 832 located within a given one of the pockets 892. For example, as shown in FIG. 8F, the third pocket 892c is aligned with the third flow channel 844c so that any fluid that flows through the third flow channel 844c can be directed toward and / or onto the third test strip 832c. With continued reference to FIG. 8F, the flow channels 844 can be covered at their respective distal ends by the swab 840 so that any fluid that flows into the flow channels 844 first passes through the swab 840 and, e.g., entrains at least a portion of the sample collected by the swab 840 and carries the sample portion toward and / or to the test strip 832 to facilitate testing the sample portion for one or more diseases.

[0069] FIG. 8G is a cross-sectional view of the housing 826 taken along section line B-B in FIG. 8A. FIG. 8H is a cross-sectional view of the diagnostic device 602 taken along section line B- B in FIG. 8 A. Both FIGS. 8G and 8H illustrate the flow channels 844 and the pockets 892 (individually identified as first, second, and third pockets 892a-c, respectively) described previously herein. FIG. 8H additional shows the test strips 832a-c positioned within the housing 826 and at least partially within the corresponding pockets 892a-c. As best seen in FIG. 8H, each of the pockets 892 and the test strips 832 can be positioned radially outwardly from a corresponding one of the flow channels 844, e.g., the first pocket 892a and the first test strip 832a radially outwardly from the first flow channel 844a, the second pocket 892b and the second test strip 832b radially outwardly from the second flow channel 844b, and the third pocket 892c and the third test strip 832c radially outwardly from the third flow channel 844c.

[0070] FIG. 81 is another cross-sectional view of the housing 826. As best shown in FIG. 81, the housing 826 can include one or more test strip support features 894 (only third test strip support feature 894c is visible). Each of the test strip support features 894 can include a fin or rib that extends radially inwardly, e.g., from an interior surface of the housing 826 toward a longitudinal axis thereof. The test strip support features 894 (e.g., the third test strip support feature 894c) can be positionedradially outwardly from corresponding ones of the flow channels 844 (e g., the third flow channel 844c). In some embodiments, the test strip support features 894 define an innermost surface that is coplanar or at least substantially coplanar with an outermost surface 896 (only third outermost surface 896c is visible) of the pockets 892 (only third pocket 892c is visible), e.g., such that the test strip support features 894 and the pockets 892 can together hold the test strips 832 in a linear or at least substantially linear orientation and / or reduce or prevent bending or deformation of the test strips 832 within the housing 826.

[0071] FIG. 8J is another cross-sectional view of the diagnostic device 602. As best shown in FIG. 8J, when the test strips 832 are positioned within the housing, each of the test strip support features 894 (e.g., third test strip support feature 894c) can contact a corresponding one of the test strips (e.g., the third test strip 832c). The test strips 832 (e.g., the third test strip 832c) can also contact the outermost surface 896 of one of the pockets 892 (e.g., the third outermost surface 896c of the third pocket 892c). As described previously with reference to at least FIG. 81, the test strip support features 894 and the pockets 892 can hold the tests strips 832 in a linear or at least substantially linear orientation and / or reduce or prevent bending or deformation of the test strips 832 within the housing 826. Each of the test strips 832 (e.g., the third test strip 832c) can be positioned between the test strip holder 842 (not shown in FIG. 8J) and a corresponding one of the test strip support features 894 (e.g., the third test strip support feature 894).

[0072] FIGS. 9A-9D are side cross-sectional views of the patient testing system of FIGS. 6A and 6B during different stages of a method, in accordance with embodiments of the present technology. Referring first to FIG. 9A, the swab 840 can be used to collect a sample from a patient or other user (e.g., as described elsewhere herein) and then the patient advance the swab 840 through the opening 714, into the first chamber portion 720a, and / or toward the seal 718 and the fluidcontaining second chamber portion 720b.

[0073] Referring next to FIG. 9B, the patient can begin to press the swab 840 against the seal 718, which can cause the seal 718 to bend or flex and, with enough force, break. Once the seal 718 is broken, the patient can advance the swab 840 to the second chamber portion 720b and, e.g., begin to immerse the swab 840, as well as the patient sample carried by the swab 840, in the fluid contained within the second chamber portion 720b.

[0074] Referring next to FIG. 9C, the patient can continue advancing the swab 840 into (e.g., further into) the second chamber portion 720b, e.g., until the distal end portion 829 of the housing 826 is placed in contact with the docking feature 774 at the end of the inner portion 710c. The inner portion 710c can be biased inwardly (e.g., radially inwardly) such that the contact between the distal end portion and the docking feature 774 can create some resistance to continued movement of the swab 840 into (e.g., even further into) the second chamber portion 720b; this resistance can, in at least some embodiments, slow, pause, or even stop (e.g., temporarily stop) any such continued movement of the swab 840.

[0075] As the diagnostic device 602 is inserted into the reagent vessel 604, the sealing element 876 can be driven into contact with and / or sealingly engage the inner portion 710c of the body 710. In the illustrated embodiment, for example, the sealing element 876 sealingly engages the inner portion 710c before the distal portion of the diagnostic device 602 has been fully inserted into the reagent vessel 604. The sealing element 876 can, accordingly, at least partially prevent the fluid within the second chamber portion 720b from leaking between the reagent vessel 604 and the diagnostic device 602. Additionally, the sealing element 876 can work together with the sealing element 764 to facilitate a fluid displacement-based transfer of fluid from the second chamber portion 720b into the diagnostic device 602 (e.g., via one or more of the flow channels 844 shown in FIGS. 8C-8J). For example, as the stem 838 is inserted into the second chamber portion 720b it displaces the fluid contained therein. The sealing element 876 can at least partially prevent the displaced fluid from leaking between the reagent vessel 604 and the diagnostic device 602 and, as described previously herein, the sealing element 764 can at least partially prevent the displaced fluid from leaking between the body 710 and the fluid reservoir 760, such that the displaced fluid can instead be urged or driven into (e.g., vertically or upwardly into) the interior of the diagnostic device 602. The sealing elements 764, 876 can also prevent, or at least partially prevent, any air trapped therebetween from leaking between the reagent vessel 604 and the diagnostic device 602 and / or between the body 710 and the fluid reservoir 760. As the diagnostic device 602 is inserted into the reagent vessel 604, the volume between the sealing elements 764, 876 decreases, which can force any air trapped between the sealing elements 764, 876 into (e.g., vertically or upwardly into) the diagnostic device 602 and may further facilitate fluid flow into the diagnostic device 602 (e.g., by entraining fluid contained within the second chamber portion 720b). In at least some embodiments, fluid displacement accounts for a majority (e.g., at least 51%, 60%, 70%, 80%, or 90%) of the fluid transfer from the reagent vessel604 into the diagnostic device 602. Compared to diagnostic devices that rely (e.g., primarily rely) on capillary action, the diagnostic device 602 is expected to obtain results faster and / or more consistently at least because of the above-described displacement-based fluid transfer.

[0076] The swab 840 can also be compressed as the diagnostic device 602 is inserted into the reagent vessel 604. For example, FIG. 9C illustrates that, as the swab 840 is advanced into the second chamber portion 720b, the wall(s) defining the second chamber portion 720b can compress or squeeze the swab 840, which is expected to increase (e.g., further increase) fluid and / or sample flow into the diagnostic device 602.

[0077] Referring next to FIG. 9D, the patient can continue advancing the swab 840 into (e.g., still further into) the second chamber portion 720b, e.g., until the distal end portion 829 of the housing 826 has been advanced distally beyond the docking feature 774 and / or the distal end 770 of the inner portion 710c. For example, as the patient advances the swab 840 from the position shown in FIG. 9C toward and / or to the position shown in FIG. 9D, the distal end portion 829 can press against the docking feature 774, pivoting the inner portion 710c and driving the distal end 770 outwardly (e.g., radially outwardly). This can continue until the distal end portion 829 moves past the docking feature 774 and / or the distal end 770, at which point the inner portion 710c can pivot back inwardly toward and / or to its original orientation. Additionally, once the distal end portion 829 is located distally beyond the distal end 770 of the inner portion 710c, the distal end 770 can face toward and / or contact the distal end portion 829, e g., to securely hold the swab 840 in the second chamber portion 720b and / or couple or “dock” the diagnostic device 602 to the reagent vessel 604.

[0078] In some embodiments, the devices of the present technology are provided as part of a kit for detecting an analyte in a patient sample, e.g., for the purposes of determining whether the patient has COVID- 19, Influenza A and / or B and / or one or more other diseases. A kit configured in accordance with embodiments of the present technology can include a diagnostic device, such as the diagnostic device 102 and / or the diagnostic device 602, and a reagent vessel, such as the reagent vessel 104 and / or the reagent vessel 604. The kit can include a test strip housed within the device. The kit can also include at least one (e.g., only one) sample swab, e.g., coupled to or separate from the diagnostic device 102 and / or the diagnostic device 602. The kit can also include instructions to, e.g., a user, for operating the diagnostic device, e.g., in accordance with FIGS. 4-5G and / or 9A-9D.

[0079] The devices and associated methods of the present technology can be used to detect many different types of analytes in a patient sample. In some embodiments, for example, the present technology can be used to detect COVID-19 from a saliva sample or a specimen from the anterior nares, mid turbinate, nasopharynx or the oropharynx. In such embodiments, the test strip in the diagnostic device can be an LFA test strip with one or more lines (e.g., dual line) having two or more antibodies that accurately detect SARS-CoV-2 virus (or antigen thereof, such as a nucleocapsid antigen) with a high signal-to-noise ratio (e.g., a strong signal with relatively low noise).

[0080] In some embodiments, the present technology uses various combinations of the following antibodies to detect SARS-CoV-2 virus or an antigen thereof: Exonbio 3E6, Sinobiological 40143-MM08, Meridian 9547, and / or Meridian 9548. These antibodies can be matched in antibody pairs or combination of three or more of the antibodies.

[0081] Any of the foregoing antibody combinations can be conjugated with nanoparticles (e.g., 150 nm gold nanoshells from nanoComposix, Inc., a California company, and / or one or more other detector reagents) and a buffer. Suitable buffers include those manufactured by Fantibody, a Chongging, China company, or a mixture of Tris and Triton XI 00 manufactured by nanoComposix, Inc with NaCl. Other buffers may be suitable as well.

[0082] Although certain embodiments herein are described with reference to diagnosing a patient with COVID-19, influenza A, and / or influenza B, in other embodiments, the present technology can be used to diagnose diseases, infections, and / or other applications involving detection of analytes in a sample. For example, the devices, methods, and kits described herein can incorporate test strips and / or other reagents configured to detect at least one analyte (e.g., an antigen) associated with any of the following diseases: chicken pox, chlamydia, Clostridium difficile infection, cytomegalovirus (CMV) infection, dengue fever, Ebola, enteric disease, giardiasis, gonorrhea, herpes simplex virus (HSV) infection, human immunodeficiency virus (HIV) infection, human papillomavirus (HPV) infection, influenza (e.g., influenza A, influenza B, influenza C), Lyme disease, malaria, measles, mononucleosis, mumps, norovirus infection, pneumonia, respiratory syncytial virus (RSV) infection, rubella, shingles, staph infection (e.g., methicillin-resistant Staphylococcus aureus (MRSA) infection), streptococcal pharyngitis, syphilis, tuberculosis, West Nile fever, or Zika fever.Examples

[0083] The present technology is illustrated, for example, according to various aspects described below as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent clauses may be combined in any combination, and placed into a respective independent clause. The other clauses can be presented in a similar manner.1. A handheld diagnostic device configured to facilitate testing a user sample for multiple diseases, the handheld diagnostic device comprising: a body defining an interior; a plurality of test strips positioned within the interior, wherein each of the plurality of test strips are configured to test the user sample for a respective disease; a stem having a proximal portion positioned within the interior and a distal portion extending distally beyond the body; a sample collection member coupled to the distal portion of the stem, wherein the sample collection member is configured to collect the user sample from a user; and one or more flow channels defined at least partially between the body and the proximal portion of the stem, wherein the one or more flow channels are configured to allow a fluid to carry at least a portion of the user sample from the sample collection member into the interior and into contact with the plurality of test strips.2. The handheld diagnostic device of clause 1 wherein the plurality of test strips includes: a first test strip configured to test the user sample for a first disease; a second test strip configured to test the user sample for a second disease, the second disease different than the first disease; and a third test strip configured to test the user sample for a third disease, the third disease different than the first disease and the second disease.3. The handheld diagnostic device of clause 2, wherein: the body includes a first side portion, a second side portion, and a third side portion;the first side portion includes a first identifier associated with the first disease; the second side portion includes a second identifier associated with the second disease; and the third side portion includes a third identifier associated with the third disease.4. The handheld diagnostic device of clause 2 or clause 3, wherein: the body includes a first side portion, a second side portion, and a third side portion; the first side portion includes a first window positioned such that at least part of the first test strip is visible therethrough; the second side portion includes a second window positioned such that at least part of the second test strip is visible therethrough; and the third side portion includes a third window positioned such that at least part of the third test strip is visible therethrough.5. The handheld diagnostic device of any of clauses 1-4, further comprising a test strip holder positioned within the interior, wherein the test strip holder includes one or more test strip coupling features configured to couple each of the plurality of test strips to the test strip holder.6. The handheld diagnostic device of any of clauses 1-5 wherein: each of the plurality of test strips has a distal end portion, the body defines a plurality of outwardly recessed pockets, wherein each of the pockets is configured to receive a corresponding one of the distal end portions, and the body includes a plurality of test strip support features, wherein each of the test strip support features is positioned proximally from a corresponding one of the pockets.7. The handheld diagnostic device of clause 6 wherein: each of the plurality of pockets has a radially outermost surface, each of the test strip support features defines a radially innermost surface, and each of the radially outermost surfaces are coplanar with a corresponding one of the radially innermost surfaces.8. The handheld diagnostic device of any of clauses 1-7 wherein the plurality of test strips includes: a first test strip configured to test the user sample for COVID-19; a second test strip configured to test the user sample for Influenza A; and a third test strip configured to test the user sample for Influenza B.9. The handheld diagnostic device of any of clauses 1-8 wherein: the body has a distal end portion that defines: a port configured to receive the proximal portion of the stem therethrough; one or more angled surfaces; and one or more planar surfaces, wherein each of the one or more planar surfaces extends proximally and from a corresponding one of the one or more angled surfaces; the one or more angled surfaces and the one or more planar surfaces are positioned radially outwardly from the port; and each of the one or more flow channels are defined by one of the one or more angled surfaces, the corresponding one of the one or more planar surfaces, and the proximal portion of the stem.10. A system for testing a user sample for multiple diseases, the system comprising: a diagnostic device, including — a housing defining an interior; a plurality of test strips positioned within the interior, wherein each of the plurality of test strips are configured to test the user sample for a respective disease; a sample collection member coupled configured to collect the user sample from a user; and one or more flow channels extending through the housing and configured to allow a fluid to carry at least a portion of the user sample from the sample collection member into the interior and into contact with the plurality of test strips; and a reagent vessel, including — a body defining an opening configured to receive a distal portion of the diagnostic device including the sample collection member;a fluid reservoir containing the fluid and configured to receive at least a portion of the diagnostic device; and a seal positioned at least partially between the body and the fluid reservoir, wherein the seal is frangible and configured to break in response to a force applied thereto via the sample collection member to allow the sample collection member to be immersed in the fluid contained within the fluid reservoir.11. The system of clause 10 wherein the reagent vessel includes: one or more spillways; and a spill chamber configured to receive at least a portion of the fluid within the fluid reservoir via the one or more spillways.12. The system of clause 10 or clause 11 wherein the body includes one or more first coupling features, wherein the fluid reservoir includes one or more second coupling features, and wherein the fluid reservoir is configured to be coupled to the body via engagement between the one or more first coupling features and the one or more second coupling features.13. The system of any of clause 10-12, wherein, in response to contact between the sample collection member and the fluid, the fluid is configured to flow from the fluid reservoir into the diagnostic device and carry at least a portion of the user sample from the sample collection member to the plurality of test strips.14. The system of any of clause 10-13 wherein: the body further includes a docking feature, the distal portion of the housing has a distal taper, and when the distal portion of the diagnostic device is advanced into the reagent vessel such that the distal taper is positioned distally from the docking feature, the docking feature is configured to couple the housing to the reagent vessel.15. The system of any of clause 10-14 wherein the distal portion of the housing includes a first sealing element configured to sealingly engage the body to at least partially prevent the fluidfrom leaking between the diagnostic device and the body of the reagent vessel, and wherein the fluid reservoir includes a second sealing element configured to sealing engage the body to at least partially prevent the fluid from leaking between the fluid reservoir and the body of the reagent vessel.16. The system of clause 15 wherein the first sealing element and the second sealing element are configured to direct the fluid within the fluid reservoir into the interior of the housing.17. The system of any of clauses 10-16 wherein the body includes: an outer body portion having a distal end, an inner body portion configured to couple the diagnostic device to the reagent vessel, and an intermediate body portion positioned radially between the outer body portion and the inner body portion, wherein the intermediate body portion is configured to couple the fluid reservoir to the body and support the fluid reservoir proximally from the distal end of the outer body portion.18. A method of testing a user with a patient testing system, the method comprising: receiving, at a diagnostic device of the patient testing system, a test sample from the user; receiving the test sample with a reagent vessel of the patient testing system; causing a plurality of tests to be performed on the test sample; and displaying, via the diagnostic device, results of the plurality of tests.19. The method of clause 18 wherein causing the plurality of tests to be performed includes causing fluid within the reagent vessel to carry at least a portion of the test sample vertically into the diagnostic device and into contact with a plurality of test strips contained therein.20. The method of clause 18 or clause 19, wherein receiving the test sample from the user includes collecting the test sample via a sample collection member of the diagnostic device, and wherein receiving the test sample within the reagent vessel includes at least partially submerging the sample collection member within a fluid contained within the reagent vessel.21 . The method of any of clauses 18-21, wherein the diagnostic device includes a plurality of test strips, and wherein causing the plurality of tests to be performed includes causing fluid within the reagent vessel to carry respective portions of the test sample to corresponding ones of the plurality of test strips.22. The method of any of clauses 18-21 wherein causing the plurality of tests to be performed includes causing the plurality of tests to be performed concurrently.23. The method of any of clauses 18-22 wherein causing the plurality of tests to be performed includes causing tests for COVID-19, Influenza A, and Influenza B to be performed.Conclusion

[0084] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. To the extent any material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Furthermore, as used herein, the phrase “and / or” as in “A and / or B” refers to A alone, B alone, and both A and B. Additionally, the terms “comprising,” “including,” “having,” and “with” are used throughout to mean including at least the recited feature(s) such that any greater number of the same features and / or additional types of other features are not precluded.

[0085] Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%. The terms “drainage rate,” “flow rate,” and “flow” are used interchangeably to describe the movement of fluid through a structure.

[0086] From the foregoing, it will also be appreciated that various modifications may be made without deviating from the disclosure or the technology. For example, one of ordinary skill in the art will understand that various components of the technology can be further divided into subcomponents, or that various components and functions of the technology may be combined and integrated. In addition, certain aspects of the technology described in the context of particular embodiments may also be combined or eliminated in other embodiments. Furthermore, although advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / W e claim:

1. A handheld diagnostic device configured to facilitate testing a user sample for multiple diseases, the handheld diagnostic device comprising: a body defining an interior; a plurality of test strips positioned within the interior, wherein each of the plurality of test strips are configured to test the user sample for a respective disease; a stem having a proximal portion positioned within the interior and a distal portion extending distally beyond the body; a sample collection member coupled to the distal portion of the stem, wherein the sample collection member is configured to collect the user sample from a user; and one or more flow channels defined at least partially between the body and the proximal portion of the stem, wherein the one or more flow channels are configured to allow a fluid to carry at least a portion of the user sample from the sample collection member into the interior and into contact with the plurality of test strips.

2. The handheld diagnostic device of claim 1 wherein the plurality of test strips includes: a first test strip configured to test the user sample for a first disease; a second test strip configured to test the user sample for a second disease, the second disease different than the first disease; and a third test strip configured to test the user sample for a third disease, the third disease different than the first disease and the second disease.

3. The handheld diagnostic device of claim 2, wherein: the body includes a first side portion, a second side portion, and a third side portion; the first side portion includes a first identifier associated with the first disease; the second side portion includes a second identifier associated with the second disease; and the third side portion includes a third identifier associated with the third disease.

4. The handheld diagnostic device of claim 2, wherein: the body includes a first side portion, a second side portion, and a third side portion;the first side portion includes a first window positioned such that at least part of the first test strip is visible therethrough; the second side portion includes a second window positioned such that at least part of the second test strip is visible therethrough; and the third side portion includes a third window positioned such that at least part of the third test strip is visible therethrough.

5. The handheld diagnostic device of claim 1, further comprising a test strip holder positioned within the interior, wherein the test strip holder includes one or more test strip coupling features configured to couple each of the plurality of test strips to the test strip holder.

6. The handheld diagnostic device of claim 1 wherein: each of the plurality of test strips has a distal end portion, the body defines a plurality of outwardly extending pockets, wherein each of the pockets is configured to receive a corresponding one of the distal end portions, and the body includes a plurality of test strip support features, wherein each of the test strip support features is positioned proximally from a corresponding one of the pockets.

7. The handheld diagnostic device of claim 6 wherein: each of the plurality of pockets has a radially outermost surface, each of the test strip support features defines a radially innermost surface, and each of the radially outermost surfaces are coplanar with a corresponding one of the radially innermost surfaces.

8. The handheld diagnostic device of claim 1 wherein the plurality of test strips includes: a first test strip configured to test the user sample for COVID-19; a second test strip configured to test the user sample for Influenza A; and a third test strip configured to test the user sample for Influenza B.

9. The handheld diagnostic device of claim 1 wherein: the body has a distal end portion that defines:a port configured to receive the proximal portion of the stem therethrough; one or more angled surfaces; and one or more planar surfaces, wherein each of the one or more planar surfaces extends proximally and from a corresponding one of the one or more angled surfaces; the one or more angled surfaces and the one or more planar surfaces are positioned radially outwardly from the port; and each of the one or more flow channels are defined by one of the one or more angled surfaces, the corresponding one of the one or more planar surfaces, and the proximal portion of the stem.

10. A system for testing a user sample for multiple diseases, the system comprising: a diagnostic device, including — a housing defining an interior; a plurality of test strips positioned within the interior, wherein each of the plurality of test strips are configured to test the user sample for a respective disease; a sample collection member coupled configured to collect the user sample from a user; and one or more flow channels extending through the housing and configured to allow a fluid to carry at least a portion of the user sample from the sample collection member into the interior and into contact with the plurality of test strips; and a reagent vessel, including — a body defining an opening configured to receive a distal portion of the diagnostic device including the sample collection member; a fluid reservoir containing the fluid and configured to receive at least a portion of the diagnostic device; and a seal positioned at least partially between the body and the fluid reservoir, wherein the seal is frangible and configured to break in response to a force applied thereto via the sample collection member to allow the sample collection member to be immersed in the fluid contained within the fluid reservoir.11 . The system of claim 10 wherein the reagent vessel includes: one or more spillways; and a spill chamber configured to receive at least a portion of the fluid within the fluid reservoir via the one or more spillways.

12. The system of claim 10 wherein the body includes one or more first coupling features, wherein the fluid reservoir includes one or more second coupling features, and wherein the fluid reservoir is configured to be coupled to the body via engagement between the one or more first coupling features and the one or more second coupling features.

13. The system of claim 10, wherein, in response to contact between the sample collection member and the fluid, the fluid is configured to flow from the fluid reservoir into the diagnostic device and carry at least a portion of the user sample from the sample collection member to the plurality of test strips.

14. The system of claim 10 wherein: the body further includes a docking feature, the distal portion of the housing has a distal taper, and when the distal portion of the diagnostic device is advanced into the reagent vessel such that the distal taper is positioned distally from the docking feature, the docking feature is configured to couple the housing to the reagent vessel.

15. The system of claim 10 wherein the distal portion of the housing includes a first sealing element configured to sealingly engage the body to at least partially prevent the fluid from leaking between the diagnostic device and the body of the reagent vessel, and wherein the fluid reservoir includes a second sealing element configured to sealing engage the body to at least partially prevent the fluid from leaking between the fluid reservoir and the body of the reagent vessel.

16. The system of claim 15 wherein the first sealing element and the second sealing element are configured to direct the fluid within the fluid reservoir into the interior of the housing.

17. The system of claim 10 wherein the body includes: an outer body portion having a distal end, an inner body portion configured to couple the diagnostic device to the reagent vessel, and an intermediate body portion positioned radially between the outer body portion and the inner body portion, wherein the intermediate body portion is configured to couple the fluid reservoir to the body and support the fluid reservoir proximally from the distal end of the outer body portion.

18. A method of testing a user with a patient testing system, the method comprising: receiving, at a diagnostic device of the patient testing system, a test sample from the user; receiving the test sample with a reagent vessel of the patient testing system; causing a plurality of tests to be performed on the test sample; and displaying, via the diagnostic device, results of the plurality of tests.

19. The method of claim 18, wherein receiving the test sample from the user includes collecting the test sample via a sample collection member of the diagnostic device, and wherein receiving the test sample within the reagent vessel includes at least partially submerging the sample collection member within a fluid contained within the reagent vessel.

20. The method of claim 18, wherein the diagnostic device includes a plurality of test strips, and wherein causing the plurality of tests to be performed includes causing fluid within the reagent vessel to carry respective portions of the test sample to corresponding ones of the plurality of test strips.

21. The method of claim 18 wherein causing the plurality of tests to be performed includes causing the plurality of tests to be performed concurrently.

22. The method of claim 18 wherein causing the plurality of tests to be performed includes causing tests for COVID-19, Influenza A, and Influenza B to be performed.

23. The method of claim 18 wherein causing the plurality of tests to be performed includes causing fluid within the reagent vessel to carry at least a portion of the test sample vertically into the diagnostic device and into contact with a plurality of test strips contained therein.

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