Devices, methods, and systems for detecting and analyzing analytes

Abstract

Detection devices, systems, and methods include those for detecting and / or analyzing analytes from a subject. In some cases, a device for detecting vaginal infections may include a container, a reactant array disposed within the container, a sampling device, a cover coupled with the sampling device. The cover may be configured to engage the container and seal the sampling component within the container. The reactant array may be configured to detect analytes emitted from a sample on the sampling device and change based on the analytes detected.

Description

Atty. Docket No. 1519.1015111DEVICES, METHODS, AND SYSTEMS FOR DETECTING AND ANALYZING ANALYTESCross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No.63 / 754,374, filed February 5, 2025, the entirety of which is incorporated herein by reference.Technical Field

[0002] The present disclosure pertains to sensing and analysis tools, and the like. More particularly, the present disclosure pertains to devices and systems for sensing and analyzing samples, and methods for manufacturing and using such devices.Background

[0003] A wide variety of devices have been developed for collection, storing, sensing, and analysis of samples. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.Brief Summary

[0004] This disclosure provides design, material, manufacturing method, and use alternatives for sensing and analysis devices. Although it is noted that collection, storing, sensing, and analysis approaches and systems are known, there exists a need for improvement on those approaches and systems.

[0005] An example device for detecting vaginal infections may include a vessel configured to receive a sample, a reactant array disposed within the vessel, and a cover configured to seal the reactant within the vessel, wherein the reactant array is configured to detect analytes emitted from the sample and change color based on the detected analytes.

[0006] Alternatively or additionally to any of the embodiments in this section, the vessel may comprise glass or plastic material.

[0007] Alternatively or additionally to any of the embodiments in this section, the device may further include a sampling device configured to obtain the sample, wherein the samplingAtty. Docket No. 1519.1015111device comprises at least one of a swab, spatula, pipette, eye dropper, cytobrush, Pipelle, curette, or brush.

[0008] Alternatively or additionally to any of the embodiments in this section, the cover may be integrated with the sampling device.

[0009] Alternatively or additionally to any of the embodiments in this section, the reactant array may comprise multiple reactants that change color upon exposure to different analytes.

[0010] Alternatively or additionally to any of the embodiments in this section, the reactant array may be configured to provide results within minutes of sealing the sample in the vessel.

[0011] In another example, a method for detecting vaginal infections may include obtaining a biological sample from a patient, placing the biological sample in a vessel containing a reactant array, sealing the vessel with a cover; and analyzing color changes in the reactant array resulting from analytes emitted from the biological sample.

[0012] Alternatively or additionally to any of the embodiments in this section, obtaining the biological sample comprises using a swab to collect vaginal fluid.

[0013] Alternatively or additionally to any of the embodiments in this section, analyzing the color changes comprises visual inspection of the reactant array.

[0014] Alternatively or additionally to any of the embodiments in this section, analyzing the color changes comprises using image processing.

[0015] Alternatively or additionally to any of the embodiments in this section, the method may include comparing the color changes to a set of test images.

[0016] Alternatively or additionally to any of the embodiments in this section, analyzing the color changes may comprise using a visual mask overlaid on the reactant array.

[0017] In another example, a system for detecting vaginal infections may include a sampling device configured to collect a biological sample, a vessel containing a reactant array, a cover configured to seal the vessel, and an analyzer configured to process color changes in the reactant array resulting from analytes emitted from the biological sample.

[0018] Alternatively or additionally to any of the embodiments in this section, the analyzer may comprise artificial intelligence configured to identify specific pathogens based on the color changes.Atty. Docket No. 1519.1015111

[0019] Alternatively or additionally to any of the embodiments in this section, the analyzer may be configured to provide quantitative information about microorganisms present in the biological sample.

[0020] Alternatively or additionally to any of the embodiments in this section, the system may be portable and configured for point-of-care use.

[0021] Alternatively or additionally to any of the embodiments in this section, the sampling device may be configured to collect the biological sample non-invasively.

[0022] Alternatively or additionally to any of the embodiments in this section, the analyzer may be configured to monitor treatment response based on changes in analyte profiles over time.

[0023] Alternatively or additionally to any of the embodiments in this section, the system may be configured to detect specific analytes associated with at least one of Gardnerella vaginalis, Candida albicans, or Trichomonas vaginalis.

[0024] Alternatively or additionally to any of the embodiments in this section, the analyzer may be configured to provide results within minutes of sealing the biological sample in the vessel.

[0025] An example device for detecting vaginal infections may include a container, a reactant array disposed within the container, a sampling device, and a cover coupled with the sampling device and configured to engage the container and seal the sampling device within the container, wherein the reactant array is configured to detect analytes emitted from a sample on the sampling device and change based on the analytes detected.

[0026] Alternatively or additionally to any of the embodiments in this section, the container may include an optical window aligned with the reactant array.

[0027] Alternatively or additionally to any of the embodiments in this section, the cover may be configured to position the sampling device at a predetermined location within the container relative to the reactant array and the optical window.

[0028] Alternatively or additionally to any of the embodiments in this section, the sampling device may include at least one of a swab, spatula, pipette, eye dropper, cytobrush, Pipelie, curette, or brush.

[0029] Alternatively or additionally to any of the embodiments in this section, the reactant array may include multiple reactants that change upon exposure to different analytes.Atty. Docket No. 1519.1015111

[0030] Alternatively or additionally to any of the embodiments in this section, the reactant array may be disposed on a porous substrate within the container.

[0031] An example method for detecting vaginal infections may include obtaining a biological sample from a vaginal region of a subject, placing the biological sample in a container configured to be in fluid communication with a reactant array, sealing the container with a cover, and analyzing one or more changes in the reactant array resulting from analytes emitted from the biological sample.

[0032] Alternatively or additionally to any of the embodiments in this section, obtaining the biological sample may include swabbing the vaginal region to collect vaginal fluid.

[0033] Alternatively or additionally to any of the embodiments in this section, analyzing the changes may include visual inspection of the reactant array.

[0034] Alternatively or additionally to any of the embodiments in this section, analyzing the changes may include using a computer image processing system.

[0035] Alternatively or additionally to any of the embodiments in this section, the method may include comparing the one or more changes in the reactant array to a set of test images of the reactant array.

[0036] Alternatively or additionally to any of the embodiments in this section, analyzing the changes may include using a visual mask overlaid on the container.

[0037] Alternatively or additionally to any of the embodiments in this section, the method may include after a predetermined time period after sealing the container with the cover, removing the reactant array from the container, wherein analyzing the one or more changes of the reactant array may be performed with a reader device remote from the container.

[0038] Alternatively or additionally to any of the embodiments in this section, analyzing one or more changes in the reactant array may include detecting analytes emitted from the biological sample associated with at least one of Gardnerella vaginalis, Candida albicans, Bacterial vaginosis, or Trichomonas vaginalis.

[0039] An example system for detecting vaginal infections may include a sampling device configured to collect a biological sample from a vaginal region of a subject, a container containing a reactant array, a cover configured to seal the container, and a reader device configured to process changes in the reactant array resulting from analytes emitted from the biological sample.Atty. Docket No. 1519.1015111

[0040] Alternatively or additionally to any of the embodiments in this section, the reader device may be configured to provide quantitative information about microorganisms present in the biological sample.

[0041] Alternatively or additionally to any of the embodiments in this section, the system may be portable and configured for point-of-care use.

[0042] Alternatively or additionally to any of the embodiments in this section, the sampling device may include a swab and is coupled with the cover.

[0043] Alternatively or additionally to any of the embodiments in this section, the reader device may be configured to monitor a response to treatment of a detected condition of the subject based on changes in analyte profiles over time.

[0044] Alternatively or additionally to any of the embodiments in this section, the system may be configured to detect specific analytes associated with at least one of Gardnerella vaginalis, Candida albicans, Bacterial vaginosis, or Trichomonas vaginalis.

[0045] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.Brief Description of the Drawings

[0046] The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:

[0047] FIG. l is a schematic diagram of an illustrative sensing system;

[0048] FIG. 2 is a schematic diagram of an illustrative computing system;

[0049] FIG. 3 is a schematic diagram of an illustrative sensing system in a hand of a user;

[0050] FIG. 4 is a schematic perspective view of an illustrative container;

[0051] FIG. 5 is a schematic perspective view of an illustrative sampling device;

[0052] FIGS. 6A and 6B schematically depicts an illustrative insertion of the instrument of FIG. 5 into the container of FIG. 4;

[0053] FIG. 7 is a schematic perspective view of an illustrative detecting device;

[0054] FIG. 8A and 8B schematically depict an insertion of an illustrative sampling device into an illustrative container; andAtty. Docket No. 1519.1015111

[0055] FIG. 9 is a schematic diagram of an illustrative method for detecting vaginal infections.

[0056] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.Detailed Description

[0057] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0058] The term “fluid” is inclusive of both liquids and gases.

[0059] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure.

[0060] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0061] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0062] It is noted that references in the specification to “a configuration”, “some configurations”, “other configurations”, etc., indicate that the configuration described may include one or more particular features, structures, and / or characteristics. However, such recitations do not necessarily mean that all configurations include the particular features, structures, and / or characteristics. Additionally, when particular features, structures, and / or characteristics are described in connection with one configuration, it should be understood that such features, structures, and / or characteristics may also be used in connection with other configurations whether or not explicitly described unless clearly stated to the contrary.Atty. Docket No. 1519.1015111

[0063] The following detailed description should be read with reference to the drawings in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure. Additionally, it should be noted that in any given figure, some features may not be shown, or may be shown schematically, for clarity and / or simplicity. Additional details regarding some components and / or method steps may be illustrated in other figures in greater detail. The devices and / or methods disclosed herein may provide a number of desirable features and benefits as described in more detail below.

[0064] Fluids with concentrations of volatile compounds (e.g., volatile organic compounds (VOCs)) and / or gasses, which may or may not be hazardous, may be sensed, analyzed, and / or monitored. Sensing, analyzing, and / or monitoring of fluids with analytes (e.g., non-volatile or volatile compounds, gases, liquids and / or other fluids) may utilize absorption and / or reflectance measurements of reactants exposed to such fluids for any purpose including, but not limited to, diagnostic hazard warning, manufacturing processes or quality control, record keeping, archival purposes, product development, product-consumer matching, etc.

[0065] In some cases, VOCs and / or gasses may be present in ambient fluid (e.g., ambient air, etc.) and sensed, analyzed, and / or monitored using reactants for real-time alarms, to treat subjects, or to collect and / or archive data for health records, regulatory compliance records, etc. Further, VOCs and / or gasses exhaled or emitted, excreted, emanated, released, and / or secreted from a subject (e.g., humans, animals other than humans, food, produce, meat, pathogens, bacteria (e.g., good and / or bad bacteria), plants, wounds, ulcers, surgical sites, skin of a subject, mouth of a subject, nasal passages of a subject, sinuses of a subject, rectum area of a subject, vaginal area of a subject, genitals area of a subject, ear canals of a subject, pores of a subject, etc.) may be sensed, analyzed, and / or monitored to assess hazardous, dangerous, or illegal substances in or at the subject or target site, a lung condition of lungs of a subject, a condition of a blood disease, a condition of infections, conditions related to diseases or biological conditions, conditions related to general health, conditions related to food flavors, conditions related to perfumes or smells, and / or other suitable conditions.

[0066] The devices, systems, and methods discussed herein may utilize techniques for non-invasively detecting one or more analytes of interest (e.g., one or more pathogens responsible for specific human skin infections including, but not limited to, skin infections, urinary tractAtty. Docket No. 1519.1015111infections (UTIs), vaginitis, wound infections, ulcers, etc., and / or other suitable analytes) from a fluid using a reactant array to allow for early detection of and early implementation of protocols to address one or more conditions associated with any sensed analytes of interest. Enhanced classification of one or more analytes detected using the systems described herein may enable detection and identification of responsible analyte at the very beginning stages of a dangerous skin infection, reaction, or condition, which may result in a high level of protection and probability of a favorable outcome for subjects.

[0067] The disclosed concepts may be configured to detect analytes that may be specific to women’s health including, but not limited to, analytes specific to gynecological and / or pelvic health. Analytes specific to women’s health may be detected and / or analyzed to determine an underlying health status or condition of a woman using 1) a direct sensing / detection of analytes from one or more accessible locations for a detector device and / or 2) acquiring a biological sample and sensing / detecting analytes in or of the sample at one or more locations remote from the woman.

[0068] Point of care understanding of the gynecological / pelvic health of a women during a medical exam, self or practitioner administered, or practitioner visit at the time of examination is desired relative to the current situation which may take days to obtain results from samples collected during the medical exam or practitioner visit. The immediate or quick understanding of the gynecological / pelvic health of a female is not only useful for detection of disease or infection, but also useful toward understanding the overall state of health for the female. Contrary to many approaches in medicine using 100+ year old technology (e.g., cultures) for identifying disease or infection that results in delays and sometimes a need for multiple samples and / or retesting, the concepts disclosed herein provide for real-time testing, results, and monitoring, while being configured to effect a relatively comfortable or non-invasive testing process for the female.

[0069] Although the devices, systems, and methods discussed herein may be described as facilitating non-invasively detecting one or more analytes of interest, the devices, systems, and methods may also or alternatively be used to invasively detect one or more analytes of interest. For example, the concepts disclosed herein provide for real-time testing, results, and monitoring of samples obtained from a gynecological region of a female anatomy that may require invasive techniques (e.g., samples from the birth canal, uterus, etc.). In some examples,Atty. Docket No. 1519.1015111the samples obtained from the gynecological region of the female anatomy may include tissue (e.g., uterus tissue, etc.)

[0070] The concepts disclosed here may include devices configured to obtain, gather, collect, or otherwise acquire biologic samples from a female’s vaginal and / or uterine anatomy. The samples gathered may be analyzed to identify disease, infection, and / or overall health / wellbeing of the patient.

[0071] Turning to the Figures, FIG. 1 depicts a schematic diagram of an illustrative system 10 for detecting analytes with a reactant array and analyzing the reactant array. Among other components the system 10 may include a detecting device or detector 12 and a reader device 14. The detector 12 may include a container 13 having a reactant array 18 and a sampling device 16. The reader device 14 may be configured to monitor and / or analyze the reactant array 18. In some configurations, the sampling device 16 may include a sample collector 26 configured to collect a sample from a target area (e.g., a vaginal region and / or other region) of the subject for analysis using the container 13 and / or the reader device 14.

[0072] The reader device 14 may be separate from (e.g., remote from) or part of the detecting device 12. In some examples, the reader device 14 may be incorporated into the container 13 or the container 13 may be incorporated into the reader device, but other suitable configurations are contemplated. In some examples, the reader device 14 may be omitted from the sensing system 10 and the user may visually monitor the reactant array 18 (e.g., through the container 13 and / or in other suitable manners). In some examples, the reader device 14 may be incorporated into a computing device, such as a mobile device, mobile phone, laptop, tablet, and / or other suitable computing device or mobile device. When the reader device 14 is incorporated in or is a computing device or mobile device, the reader device 14 may run a specialized application that performs the functions of the reader device 14 discussed herein.

[0073] The detector 12 may have any suitable configuration and may include any suitable components configured to facilitate receiving a sample for analysis, sensing analyte from the sample, and viewing and / or analyzing the reactant array 18. Example components of the detector 12 include, but are not limited to, the sampling device 16 with a sample collector 26, and the container 13 with one or more reactant arrays 18, one or more compartments 20, one or more covers 22, one or more specimen detectors 24, and / or one or more other suitable components and / or configurations. In some examples, the specimen detector 24 may beAtty. Docket No. 1519.1015111omitted. Components that detector 12 may include but are not depicted in FIG. 1 include, but are not limited to, a housing, a window for viewing the reactant array 18, a lock, an engagement component for breaking a seal isolating the reactant array 18 from ambient, one or more gaskets or other features for hermetically sealing the one or more compartments, one or more access openings extending between the compartments and exterior of the housing, one or more valves configured to seal the access opening, one or more doors or lids, one or more pumps for pumping fluid from a location of the sample to the reactant array 18, one or more fluid paths or passages, tubing, one or more diaphragms or membranes, one or more single-use components, and / or other suitable components.

[0074] Although not depicted in FIG. 1, the container 13 may include the housing, where the housing may be configured to at least partially enclose or house all or one or more of the reactant arrays 18, the compartments 20, and the specimen detectors 24. The housing may be configured to engage the cover 22 to seal the reactant array within the housing. The housing may be a single component with an opening between the one or more compartments 20 and an exterior of the detector 12 and / or a plurality of components defining the opening between the one or more compartments 20 and the exterior of the detector 12.

[0075] The housing may be formed in any suitable manner. In some examples, the housing may be formed with one or more molding techniques, injection molding techniques, welding techniques, ultrasonic welding techniques, three-dimensional (3D) printing techniques, and / or other suitable techniques.

[0076] The housing of the container 13 may be formed from any suitable material. Example suitable materials include, but is not limited to, polymers, metals, glass, and / or other suitable types of materials.

[0077] The housing of the container may have any suitable shape and / or size configured to receive a specimen and facilitate analyzing the reactant array 18 in the detector 12 visually and / or using the reader device 14. For example, the container 13 may have a cube shape, an elongated shape, a rectangular shape, an oval shape, a rounded shape, a circular shape, a cylindrical shape, ajar shape, a ball shape, and / or other suitable shape.

[0078] The reactant array 18 may be any suitable array of one or more reactants (e.g., analyte sensitive material) and the reactants of the reactant array 18 may be formed from any suitable material. The detector 12 (e g., the housing of the container 13, etc.) may beAtty. Docket No. 1519.1015111configured to entirely or at least partially house or enclose the reactant array 18 (e.g., the CSA including the reactant array 18). In some cases, the reactant array 18 may be part of or form a colorimetric sensor array (CSA), but other suitable configurations are contemplated. Additionally or alternatively, the reactant array 18 be formed by applying the material of the reactants to an entirety or at least a portion of an internal surface of the container 13 (e.g., surface(s) of the compartments 20, the surface(s) of the cover 22) and the applied reactant material may be a continuous pattern, partitioned, segmented, perforated, and / or one or more other suitable designs or configurations.

[0079] The material of the reactants of the reactant array 18 may be reversible (e.g., reusable), semi-reversible, or non-reversible (e.g., single use). In some examples, the material of the reactants may be an optically responsive chemical material (e.g., a chemoresponsive material) that changes color in response to detecting one or more analytes (e.g., volatile compounds gasses, liquids, and / or other fluids) in a fluid to which the reactants are exposed, but other suitable material is contemplated. Example suitable materials for reactants include dyes from, but not limited to, the following classes: Lewis acid / base dyes (e.g., metal containing dyes), Brensted acidic or basic dyes (e.g., pH indicators), dyes with large permanent dipoles (e.g., solvatochromic dyes), redox responsive dyes (e.g., metal nanoparticle precursors), and / or other suitable classes of dyes. One example material for the reactants may be a silver nanoparticle material. Other suitable materials for the reactants are contemplated, including reactant material other than a printed dye or an optically responsive chemical material.

[0080] The reactants of the reactant array 18 may be applied to a substrate. When the reactant array 18 forms or is otherwise part of a CSA, the substrate may or may not be part of the CSA. Additionally or alternatively, the substrate may be the container 13 (e.g., the housing of the container 13 and / or other suitable component of the container 13) or a component configured to be received in the container 13 (e.g., in one or more of the compartments 20).

[0081] The reactants of the reactant array 18 may be applied to a substrate in any suitable manner. In one example, the reactants may be applied to the substrate by printing the reactants (e.g., the material of the reactants) on the substrate. When printed, any suitable printing techniques may be utilized including, but not limited to, pin transfer, inkjet, silkscreen, and / or other suitable application techniques.Atty. Docket No. 1519.1015111

[0082] The reactants may be applied to the substrate randomly and / or to form one or more patterns. Example configurations of the reactants of the reactant array applied to the substrate include, but are not limited to, grid patterns of rows and columns, concentric rings, color matching of a color of printed dye material with a color of a substrate material prior to interactions of the reactants with analyte, patterns that result in identifiable shapes when the analyte sensitive material reacts to a particular analyte, other suitable configurations, and / or combinations thereof.

[0083] The one or more compartments 20 of the container 13 may be entirely or at least partially defined by the housing of the container 13. The one or more compartments 20 may be in fluid communication with one or more access openings extending from an exterior side of the container 13 (e.g., the housing of the container) into the one or more compartments 20. In some examples, the access opening may be configured to receive the sample collector 26 for positioning in the one or more compartments 20.

[0084] The one or more compartments 20 may include any suitable configuration of compartments 20. For example, the compartments 20 may define a fluid path from a location of the sample collector 26 to the reactant array 18, may be a single compartment 20 configured to include the reactant array 18 and receive the sample collector 26, may be or include a plurality of compartments fluidly coupled to allow fluid to pass between a location of the sample collector 26 and a location of the reactant array 18, and / or the compartment(s) 20 may have one or more other suitable configurations. Although not depicted, the one or more compartments 20 may be or may include one or more tubes defining at least part of a fluid path from a location of the sample collector 26 (and the sample) to the reactant array 18.

[0085] Once the sample collector 26 with a sample or specimen thereon is received in or at the container 13, the container 13 may maintain the sample collector 26 in or at the compartment 20 or may allow the sample collector 26 to be removed from the container 13 prior to, during, and / or after analysis of a sample (e.g., fluids from the sample) on or of the sample collector 26. In some configurations, the compartment 20 of the container 13 may be sealed in response to receiving the sample collector 26, but other configurations are contemplated. After a sample is received in the container 13, fluids thereon or therein may emanate from the sample and / or permeate through the reactant array 18 within or in fluid communication with the container 13.Atty. Docket No. 1519.1015111

[0086] The cover 22 may be configured to secure or seal the sample in the container 13. The cover 22 may be configured to seal or couple with the housing of the container 13 in any suitable manner. In some examples, the cover 22 may include a first engagement feature and the container 13 may include a second engagement feature configured to engage with the first engagement feature. The engagement features may be any suitable types of engagement features including, but not limited to, threads, magnets, latches, mating components, and / or other suitable engagement features that may engage one another to create a seal (e.g., a hermetic seal) between the container 13 and the cover 22.

[0087] The cover 22 may be coupled with the sample collector 26. In some examples, the cover 22 may be part of the sampling device 16 in addition to or as an alternative to being part of the container 13. In some examples, the sample collector 26 may extend from the cover 22 such that the sample collector 26 may be positioned within the compartment 20 of the container 13 when the cover 22 is coupled with the housing of the container 13 seal the compartment 20.

[0088] A lock of the container 13 may have any suitable configuration when included. In some examples, the lock may be any suitable component that is configured to selectively block access to the compartments 20 via the access opening. When the housing of the container 13 includes multiple components adjustable relative to one another between an opened position to define the access opening and a closed position to block access to the compartments 20 via the access opening, the lock may be configured to fix the multiple components relative to one another (e g., in the closed position and / or other suitable position). In some examples, the lock may be configured to lock the cover 22 in a desired position with respect to the housing of the container 13.

[0089] The lock may be configured to secure the sample collector 26 relative to the compartment(s) 20. In one example, the lock may include a blade or blade surface that is configured to cut the sampling device 16 into two sub-components and then seal the access opening to the compartment(s) 20. Alternatively or additionally, the lock including the blade or blade surface configured to cut the sampling device 16 may be a portion of a component of the housing of the container 13 that is configured to sever the sampling device 16 inserted in the container 13 into a sample portion that is secured in the compartment 20 of the container 13 and a non-sample portion that is removed from the detector. In some examples, receiving the sampling device 16 in the access opening may trigger the lock to close off the accessAtty. Docket No. 1519.1015111opening and / or engage the sampling device to prevent removal of the sampling device 16. Other suitable features of the lock may include, but are not limited to, features that engage a received sampling device 16, features that prevent removal of a received sampling device 16 after placement of the sampling device 16 in the compartment 20, spring loaded doors, automated doors, bolts, latches, magnets, and / or other suitable features of locks configured to prevent removal of the sampling device 16 from the housing, encourage single-use of the container 13 (e.g., to prevent cross-contamination of samples), and / or coupling multiple components of a housing to one another and / or the sampling device 16.

[0090] In some examples, the lock may be irreversible such that the sampling device 16 cannot be removed from the container 13 and the lock may facilitate ensuring the sampling device 16 and the container 13 are only used to test one sample. In other examples, the lock may be reversible to allow the sampling device 16 to be rearranged relative the container 13.

[0091] Any suitable type of locks may be utilized. Example suitable types of locks include, but are not limited to, automatically actuated locks, manually actuated locks, spring loaded locks, latches, dead bolts, friction fit locks, and / or other suitable types of locks that are configured to block the access opening and / or engage the specimen to prevent removal and / or adjustment of the sampling device 16 relative to the container 13.

[0092] The detector 12 may include one or more specimen detectors 24. In some examples, the specimen detector 24 may be configured to detect when a specimen is proximate and / or received in the container 13 and may or may not be part of the lock, when the lock is included. In one example, the specimen detector 24 may be a pin or button or other component in communication with a spring-loaded lock, where the pin or button or other component detects the specimen and releases a spring of the lock to lock the sampling device within the container 13. Alternatively or additionally, the specimen detector 24 may be an electronic sensor or detector and / or other suitable type of detector that may provide an indication to the reader device 14 indicating that a sample has or has not been received in the container 13 (e.g., has or has not been properly received in the container).

[0093] In addition to or as an alternative to the lock and / or the specimen detector 24, the detector 12 may include a single-use component configured to prevent contamination due to reuse of the detector. In some cases, the single-use component may be a mechanical, electrical, electromechanical, optical, chemical, magnetic, and / or other suitable type of single-use featureAtty. Docket No. 1519.1015111that changes in response to being used with a single-use or reusable reader device 14 for analyzing the reactant array 18. In one example of a single-use component for the detector 12, an electronic single-use component may be imbedded within the container 13 and either recognized by the reader device 14 as being intact or broken to indicate whether the detector 12 is new or has been used, respectively. Example electronic single-use components include, but are not limited to a memory device, radio-frequency identification (RFID) devices, a fuses, and / or other suitable electronic single-use components. When a memory device is used as a single-use component of the detector 12, the memory device may be accessed by the reader device 14 and modified by the reader device 14 after the detector 12 has been inserted into the reader device 14. When a fuse is used as a single-use component, the fuse may be broken (e.g., via excessive current or in other suitable manners) after the reader device 14 analyzes the reactant array 18, where the reader device 14 may be configured to identify the broken fuse and the detector 12 with the broken fuse may be prevented from being used in a subsequent analysis. Further, the single-use component may be or may include at least one visual indicator that may change state after sampling device has been coupled with the container 13 and / or the detector 12 has been used with the reader device 14. When the single-use component includes a visual indicator, the visual indicator may be captured by an image capture sequence of the reader device 14, where the reader device 14 prevents analysis of the reactant array 18 of the detector 12 if the reader device 14 determines from the indicator that the detector 12 has been used. A user may also recognize the visual indicator and discard the detector 12 when the visual indicator indicates the detector has been previously used.

[0094] In some cases, the detector 12 may be reusable. For example, in instances when the reactant array 18 and / or other components of the detector 12 that may be spent or contaminated with a received fluid, the reactant array 18 and / or other spent or contaminated components of the detector 12 may be removed from the detector 12 and the remaining components of the detector 12 may be reused after cleaning and being refurbished, as needed. In some cases, the reactant array 18 may include reversible reactant material and the reactant array 18 may be reused with other components of the detector 12.

[0095] The sampling device 16 may be configured to collect a sample from a target area, where the sample is configured to exude fluids. In some examples, the sampling device 16 may include the sample collector 26 configured to contact a target area to collect a sample thatAtty. Docket No. 1519.1015111exudes fluid. The sampling device 16 may include a non-sample portion along with the sample collector 26, where the non-sample portion may be handled by a user or extend to a handle or the cover 22 for handing by a user for positioning the sample collector at the container 13 and / or to collect the sample. When the sampling device 16 is positioned within a compartment 20 of the container 13 or coupled with the container 13, the sample collector 26 of the sampling device 16 may be inserted into the compartment 20 and the non-sample portion may extend out of the compartment 20, but other suitable configurations are contemplated.

[0096] The sampling device 16 may be any suitable type of sampling device configured to collect a sample from a target area with the sample collector 26. Example suitable types of sample collectors 26 and / or sampling devices 16 include, but are not limited to, swabs, swabs on a stick (e.g., a Q-tip), containers, sponges, sample plates, test strips, containers, needle sticks, syringes, spatulas, pipettes, eye droppers, cytobrushes, Pipelle, curettes, brushes, and / or other suitable types of or components including sample collectors 26 configured to support a sample.

[0097] The reader device 14 may include one more suitable components for reading and / or analyzing the reactant array 18. Example suitable components of the reader device 14 include, but are not limited to, illumination components, light collection components, one or more light or image sensor 28, one or more container detectors 30, one or more controllers 32, one or more light sources, one or more sets of lenses, one or more motors, one or more pumps, one or more buttons, one or more user interfaces, one or more displays, and / or other suitable components. In some examples, the reader device 14 may be a bench top device or a handheld device. In some cases, the reader device 14 may be isolated from the sample of the sample collector 26 and may be configured for reuse. In some examples, the reader device 14 may be part of the detector 12 and / or intended to be a single-use device.

[0098] The reader device 14 may be powered with any suitable power source. Example suitable power sources for powering the reader device 14 include, but are not limited to, battery power in the reader device 14, solar power at the reader device 14, wall or line power, and / or other suitable power sources. In some examples, to facilitate forming the reader device 14 with a handheld configuration, the reader device 14 may be powered by one or more batteries and / or by solar power.Atty. Docket No. 1519.1015111

[0099] The light or image sensor 28 may be and / or may include one or more light collectors of any suitable type. Example suitable types of light collectors may include, but are not limited to, a light sensor, an image sensor, an n-dimensional sensory array (e.g., where “n” equals 1, 2, etc.), a linear 2D light detector array image sensor, light detector array image sensor, a spectrometer, a refractometer, a charge-coupled device (CCD) image sensor, complementary metal-oxide semiconductor (CMOS) image sensor, contact image sensor (CIS), color contact image sensor (CCIS), a camera, other suitable light collectors, and / or combinations of light collectors. In one example, the light collector may include or may be a spectrometer configured to measure photons collected from (e.g., reflected, transmitted, and / or otherwise received from) the reactant array. Utilizing a spectrometer may facilitate sensing wavelengths of light with high resolution in the nanometer range and may provide a continuous set of data over the wavelength range, which allows for a sensitive analysis of the data to identify components of a fluid to which the reactant array 18 was exposed relative to when other light collectors are used. In another example, the light collector may include a 2D pixel array image sensor configured to record multiple spatial interferograms in a pixel array direction of an interferogram representing a Fourier transform of the reactant array 18, which may provide sufficient sensitivity, while being compact and cost-effective.

[0100] The reader device 14 may include one or more container detectors 30. In some examples, the container detector 30 may be configured to detect when the detector 12 is proximate and / or received in the reader device 14. In one example, the container detector 30 may be a pin or button or other component, where the pin or button or other component physically or mechanically engages the container 13 as the detector 12 is inserted into or positioned at the reader device 14 and in response, the pin or button or other component adjusts and provides a mechanical and / or electrical (e.g., completes a circuit, etc.) indication that the detector 12 has been received. Alternatively or additionally, the container detector 30 may be an electronic sensor or detector and / or other suitable type of detector that may provide an indication to the reader device 14 indicating that the detector 12 is proximate and / or has or has not been received in the reader device 14 (e.g., has or has not been properly received in the reader device 14). In some cases, the electronic sensor or detector may sense a signal from the detector 12 (e.g., an RF signal), sense the detector 12 breaking a circuit of the reader device 14, completing a circuit of the reader device 14 and / or the detector 12, and / or sense a presenceAtty. Docket No. 1519.1015111of the detector 12 in one or more other suitable manners. In some examples, the container detector(s) 30 may be omitted.

[0101] In addition to or as an alternative to the container detector 30, the reader device 14 may include a single-use component. The single-use component of the reader device 14 may include a feature configured to electrically, mechanically, or electrically and mechanically modify the detector 12 such that the detector 12 will not be used more than once by the reader device 14 (e.g., in more than one test by the reader device 14). Example single use components include, but are not limited to, a component configured to write to an RFID tag of the detector 12, a component configured to mechanically alter the detector 12 to prevent recoupling of the detector 12 after the detector 12 has been removed from the reader device 14, a camera configured to read a code (e.g., a bar code, QR code, alphanumerical code, color code, etc.) on a surface of the detector 12 or an RFID reader configured to read a code from an RFID of the detector 12 and add the code or other identifying material to a list of used detectors 12 in memory of the reader device 14 and / or in communication with the reader device 14.

[0102] The container detector 30 and / or other suitable detector of the reader device 14 may be configured to detect when the sample collector 26 is within or at the container 13. For example, the detector 12 may be inserted into the reader device 14 before the sample collector 26 is within the container 13 and the container detector 30 may detect when the sample collector 26 is inserted into the container 13 after the detector 12 is inserted into the reader device 14. Upon sensing the detector 12 in the reader device 14 and the sample collector 26 in the container 13, the reader device 14 may initiate a light or image collection from the reactant array 18 as part of a fluid analysis test of a sample on the sample collector 26 and / or a request for input from a user to perform one or more steps of the fluid analysis test.

[0103] The controller 32 of the reader device 14 may be configured to control operations of the reader device 14 in response to receiving one or more control signals and / or use inputs. The controller 32 may store captured data at the reader device 14 and / or send data to a remote storage component for storage and / or processing and the controller 32 may use stored captured data to analyze the reactant array 18. Further the controller 32 may be implemented entirely on the reader device 14, partially on the reader device 14 and partially remotely, and / or entirely remotely (e.g., on a server or other suitable computing device, on the detector 12, on a user’s mobile device, etc.)Atty. Docket No. 1519.1015111

[0104] The controller 32 of the reader device 14 may be coupled to one or more other electronic components of the system 10. For example, the controller 32 may be communicatively coupled with one or more of the illumination components, when included, the light or image sensor 28, the container detector 30, the single-use component, and / or one or more other suitable components of the system 10 and / or remote components (e.g., servers, mobile devices, etc.) that may or may not be part of the system 10. In some examples, the controller 32 may be configured to receive an indication to initiate a fluid test (e.g., from a user via a user interface of or in communication with the controller 32, from the container detector 30, etc.) and send coordinated control signals to one or more electronic components of the system 10.

[0105] The controller 32 may be configured to identify or may facilitate identifying a component of fluid in contact with the reactant array 18 and / or a condition of a target area based on measured (e.g., sensed and / or calculated) levels of light (e.g., interferograms, images, reflectance, etc.) or changes in light sensed or collected from the reactant array 18 with the light or image sensor 28. In some examples, the controller 32 may be configured to identify a component of fluid in contact with the reactant array 18 and / or a condition of the target area based on one or more of a timing of levels of light from the reactant array 18 and an absolute change between a level of light from the reactant array 18 at a time of or prior to inserting the sample collector 26 of the sampling device 16 into or exposing the sample collector 26 to the compartment 20 of the container 13 and at a predetermined time after initially inserting the sample collector 26 in the compartment 20, and levels of light from the reactant array 18 relative to predetermined or expected levels of light from the reactant array 18. The controller 32 may be configured to identify the component of the fluid in contact with the reactant array 18 and thus, a component of the sample at the sample collector 26 of the sampling device 16 and / or a condition at a location from which the sample was taken (e.g., a vaginal region of a subject or other suitable location) based on light from the reactant array 18 that is received at the light or image sensor 28 in one or more additional or alternative manners.

[0106] The controller 32 and / or other components of the system 10 may be or may include one or more computing devices including or coupled with one or more user interfaces. FIG. 2 depicts a schematic diagram of an illustrative computing device 38 and a user interface 40, where the computing device 38 and / or the user interface 40 may be entirely or partially housedAtty. Docket No. 1519.1015111in one or more housings 42 (e.g., a housing which may or may not house other components of the system 10). The housing 42 may be an optional component, as represented by the broken lines defining the housing 42 depicted in FIG. 2. Although various components are depicted as being included in the computing device 38 and the user interface 40, one more of the depicted components may be omitted and / or one or more additional or alternative components may be utilized.

[0107] The computing device 38 may be any suitable computing device configured to process data of or for the system 10 and may be configured to facilitate operation of the system 10. The computing device 38, in some cases, may be configured to control operation of the system 10 by establishing and / or outputting control signals to the light or image sensor 28 and / or other electronic components of the system 10 to run a test on fluid from the sample collector 26 of the sample device 16 that interacts with the reactant array 18 and / or monitor results of a test. In some examples, the computing device 38 may be part of the controller 32 and may communicate with other components over a wired or wireless connection, but other suitable configurations are contemplated. When the computing device 38, or at least a part of the computing device 38, is a component separate from a structure of the controller 32, the computing device 38 may communicate with electronic components of the system 10 over one or more wired or wireless connections or networks (e.g., LANs and / or WANs). In some cases, the computing device 38 may communicate with a remote server or other suitable computing device.

[0108] The illustrative computing device 38 may include, among other suitable components, one or more processors 44, memory 46, and / or one or more input / output (I / O) units 48. Example other suitable components of the computing device 38 that are not specifically depicted in FIG. 2 may include, but are not limited to, communication components, a touch screen, selectable buttons, and / or other suitable components of a computing device. As discussed, one or more components of the computing device 38 may be separate from the controller 32 and / or incorporated into the components of the controller 32.

[0109] The processor 44 of the computing device 38 may include a single processor or more than one processor working individually or with one another. The processor 44 may be configured to receive and execute instructions, including instructions that may be loaded into the memory 46 and / or other suitable memory. Example components of the processor 44 mayAtty. Docket No. 1519.1015111include, but are not limited to, central processing units, microprocessors, microcontrollers, multi-core processors, graphical processing units, digital signal processors, application specific integrated circuits (ASICs), artificial intelligence accelerators, field programmable gate arrays (FPGAs), discrete circuitry, and / or other suitable types of data processing devices.

[0110] The memory 46 of the computing device 38 may include a single memory component or more than one memory component each working individually or with one another. Example types of memory 46 may include random access memory (RAM), EEPROM, flash, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read only memory (ROM), hard drive, flash memory, optical disc memory, and / or other suitable persistent memory) and / or other suitable types of memory. The memory 46 may be or may include a transitory or a non-transitory computer readable medium. The memory 46 may include instructions stored in a transitory state and / or a non-transitory state on a computer readable medium that may be executable by the processor 44 to cause the processor 44 to perform one or more of the methods and / or techniques described herein. Further, in some cases, the memory 46 and / or other suitable memory may store data received from the light or image sensor 28 and / or other components of or in communication with the system 10.[OHl] The VO units 48 of the computing device 38 may include a single I / O component or more than one I / O component each working individually or with one another. Example I / O units 48 may be or may include any suitable types of communication hardware and / or software including, but not limited to, communication components or ports configured to communicate with electronic components of the system 10 and / or with other suitable computing devices or systems. Example types of I / O units 48 may include, but are not limited to, wired communication components (e.g., HDMI components, Ethernet components, VGA components, serial communication components, parallel communication components, component video ports, S-video components, composite audio / video components, DVI components, USB components, optical communication components, and / or other suitable wired communication components), wireless communication components (e.g., radio frequency (RF) components, Low-Energy BLUETOOTH protocol components, BLUETOOTH protocol components, Near-Field Communication (NFC) protocol components, WI-FI protocol components, optical communication components, ZIGBEEAtty. Docket No. 1519.1015111protocol components, and / or other suitable wireless communication components), and / or other suitable I / O units 48.

[0112] The user interface 40 may be configured to communicate with the computing device 38 via one or more wired or wireless connections. The user interface 40 may include, among other components, one or more display devices 50, one or more input devices 52, one or more output devices 54, and / or one or more other suitable features. Although not depicted, the user interface 40 may include one or more indicators (e.g., light emitting diodes (LEDs), LED linear arrays, numbers, etc.) In some examples, the user interface 40 may be part of or may include the computing device 38. Alternatively or additionally, the user interface 40 may be part of a mobile device or remote computing system.

[0113] The display 50 may be any suitable display. Example suitable displays include, but are not limited to, touch screen displays, non-touch screen displays, liquid crystal display (LCD) screens, LED displays, head mounted displays, virtual reality displays, augmented reality displays, a mobile device display, and / or other suitable display types.

[0114] The input device(s) 52 may be and / or may include any suitable components and / or features for receiving user input via the user interface 40. Example input device(s) 52 may include, but are not limited to, touch screens, keypads, mice, touch pads, microphones, selectable buttons, selectable knobs, optical inputs, cameras, gesture sensors, eye trackers, voice recognition controls (e.g., microphones coupled to appropriate natural language processing components) and / or other suitable input devices. In one example, the input devices 52 may include a touch screen that allows for setting set points, initiating a fluid or target area analysis test, adjusting between screens (e.g., a testing screen, a data analysis screen, a results screen, etc.), and / or allows for taking one or more other suitable actions.

[0115] The output device(s) 54 may be and / or may include any suitable components and / or features for providing information and / or data to users and / or other computing components. Example output device(s) 54 include, but are not limited to, displays, speakers, vibration systems, tactile feedback systems, optical outputs, and / or other suitable output devices.

[0116] FIG. 3 schematically depicts an illustrative configuration of the system 10 configured to be held in a hand 55 of a user. Although the system 10 may take on a variety of different handheld configurations (and / or non-handheld configurations), the system 10 depicted in FIG. 3 may include the detector 12 combined with the reader device 14. TheAtty. Docket No. 1519.1015111detector 12 includes the sampling device 16 coupled with the container 13 and sample collector 26 inserted into the compartment 20.

[0117] The cover 22 for the container 13 may be coupled with the sample collector 26 and may engage the container 13 to close an opening (not depicted in FIG. 3) into the container^. With the cover 22 engaging the container 13, the sample collector 26 may be position within the compartment 20 and in fluid communication with the reactant array 18. In some examples, the reactant array 18 and / or the sample collector 26 within the compartment 20 may be viewed through a window 34 in a housing 36 of the container 13. Other suitable configurations of handheld configurations of the system 10 are contemplated.

[0118] The system 10 may include the user interface 40 of the reader device 14, which may include one or more buttons 60 and / or one or more displays (e.g., the display 50, not depicted in FIG. 3). The user interface 40 may include additional and / or alternative components or features including, but not limited to, one or more indicators (e.g., LEDs, LED linear arrays, numbers, etc.) configured to indicate (e.g., as an alert, etc.) a result of a test, a test has been initiated, a test has been completed, a user is to perform an action, an action has been completed, and / or other suitable indications. Additionally or alternatively, the user interface 40 may be on or part of a remote computing device, such as a mobile device, control station, web page, mobile application, and / or other suitable remote computing device. In some examples, the user interface 40 may be entirely omitted from the reader device 14 or one or more components of the user interface 40 discussed herein may be omitted from the reader device 14.

[0119] The display (e.g., a touchscreen display or a non-touchscreen display), when included, may depict an image captured by the reader device 14 (e.g., captured by the light or image sensor 28). The image may be a live image and / or a photograph or image captured at a previous time (e.g., the images may be of the reactant array 18, the sample collector 26 and / or other suitable subjects). The display may display material other than one or more captured images including, but not limited to, instructions for testing a fluid, a test status (e.g., a progression of steps in an analysis of the reactant array 18), a system status, results of an analysis of the reactant array 18, marketing indicia, brand indicia, videos, user pictures, art work, etc.Atty. Docket No. 1519.1015111

[0120] The one or more buttons 60 may be selected by a user to cause the reader device 14 and / or the detector 12 to take one or more actions. For example, a user may interact with the one or more buttons 60 to initiate a pump of the reader device 14 and / or of the detector 12, power on and / or off the reader device 14, initiate a motor of the reader device 14, initiate an analysis of the reactant array 18, initiate the light or image sensor 28 to take an image or capture light, eject the sampling device 16, mark the sampling device 16 as used, initiate the display 50, and / or to cause the reader device 14 and / or the detector 12 to take one or more other suitable actions.

[0121] FIGS. 4-8B depict schematic views of illustrative configurations the detector device 12 and / or portions thereof. Although various features and / or examples of the detector are depicted in FIGS. 4-8B, other suitable configurations of the detector 12 including additional and / or alternative components are contemplated. In some examples, detectors 12 may be configured as point of care devices for obtaining a sample (e.g., fluid, puss, tissue, discharge, etc.) from a female subject and analyzing that sample. The following descriptions and processes can, in general, be applied to each detector 12 or portion thereof depicted in FIGS.4-8B. In some examples, the detector 12 may include the container 13 (e.g., a glass / plastic (clear or opaque) bottle, tube, pot, can, canister, etc..), the sampling device 16 to acquire a biologic sample (e.g., swab, spatula, pipette, eye dropper, cytobrush, Pipelle, curette, brush, etc.), the reactant array 18 (e.g., a colorimetric sensor array (CSA), etc ), and the cover 22 (e.g., a snap on, screw on, etc. cap / lid). The container 13, the sampling device 16, and the cover 22, when included in the detector 12, may be separate components or integrated into a single component.

[0122] Although the detector 12 is described and depicted in FIGS. 4-8B as including the sampling device 16, the sampling device 16 may be omitted. For example, the container 13, including the reactant array 18, may be placed in fluid communication with a target area (e.g., a vaginal region of the female subject) such that analytes from the target area and / or a sample from the target area may be in fluid communication with the reactant array in a manner that allows the reactants of the reactant array to react to analytes from the target area. Once the reactants have been exposed to the fluid from the target area for a predetermined period of time, the cover 22 may be coupled with the housing of the container 13 and the reactant array may be monitored and / or analyzed.Atty. Docket No. 1519.1015111

[0123] In operation, the sampling device 16 may be used to acquire a biologic sample from a female patient. The sampling device with the sample thereon may be placed into the container 13 and the cover 22 may be placed on the container 13 to seal the reactant array 18 and sampling device 16 within the container 13. The closed container may facilitate keeping outside environmental analytes and / or other molecules that may contaminate the sample and / or the reactant array 18 from interfering with the detection of analytes by the reactant array 18.

[0124] The analytes (e.g., VOCs, etc.) from the sample may fill the volume within the container 13 allowing the molecules of the analyte to interact with reactants 58 (e.g., chemical formulations) that form or make up the reactant array 18. Through the detection and / or identification of analytes from the sample based on changes in color of the reactant array 18 between a time prior to exposure to the sample, a time during exposure to the sample, and / or a time after exposure to the sample, it may be determined which, if any, bacteria, fungi, pathogen(s), metabolites etc. is in the sample. A level of change and / or a number of individual reactants that react to analytes from the sample may individually and / or collectively (in any combination) be used to decipher what bacteria, fungi, pathogen(s), etc. is / are present in the sample, quantitative information about what is present in the sample (e.g., parts per million counts, more or less than a threshold, etc.), and / or a condition of the female patient.

[0125] Analysis of the reactants 58 of the reactant array 18 may be achieved with the “naked” eye through the container 13 or with the reactant array 18 removed from the container 13 after exposure to the sample based on an absolute change in color of one or more reactants 58, based on a comparison of one or more reactants 58 to a set of test images, based on a visual mask overlaid on the reactant array, and / or in one or more other suitable manners. In some examples, analysis of the reactants 58 of the reactant array 18 may be achieved using image processing with computer vision techniques. Additionally or alternatively, the reader device 14 or other suitable computing device 38 may be used to image and / or analyze the reactant array 18, which may or may not be incorporated into the detector 12.

[0126] FIG. 4 is a schematic perspective view of an illustrative configuration of container 13 of the detector 12. In the example depicted in FIG. 4, the container 13 may include the housing 36, the reactant array 18, one or more windows 34 through the housing 36 through which the reactant array 18 may be viewed, one or more compartments 20, and one or more sample opening 62 through the housing 36 leading to the one or more compartments 20.Atty. Docket No. 1519.1015111

[0127] The sample opening 62 may be configured to receive the sampling device 16 (e.g., the sample collector 26). In some examples, one or more seals 64 may extending across and close the sample opening 62. In some exampels, the seals 64 may be configured to be broken by engagement with the sampling device 16 (e.g., the sample collector 26 may be extend into and through the seal to open the seal). In some examples, the seal may be opened and / or closed in response to an actuation of a switch or slider. In some examples, the seal 64 may be a selfsealing seal so such that the seal 64 seals around the sampling device 16 inserted therethrough. In some exampels, the seal 64 may not re-seal after the seal has been broken or opened.

[0128] The seal 64 may be formed in any suitable configuration. For example, the seal 64 may be formed from silicone, paper, foil, a pliable material, a flexible material, a rigid material, and / or other suitable material configured to open or be broken in response to receive a force or actuation. In some examples, the seal 64 may include a slit, perforation 66, and / or other suitable configuration to facilitate breaking the seal 64 with the sampling device 16 or other suitable component. In some examples, the seal 64 may include a foil component with perforations that are configured to facilitate opening or breaking seal upon engaging with a sampling device 16. In some examples, the seal 64 may include one or more pliable components and one or more slits configured to facilitate opening or breaking the seal with the sampling device 16.

[0129] The sample opening 62 may have any suitable size for receiving the sampling device 16. For example, the sample opening 62 may have any suitable shape including, but not limited to, rectangular, circular, elongated, star, square, and / or other suitable shapes. In some examples, the sample opening 62 may be sized and shaped so as to receive the sample collector 26 without the sample collector 26 engaging the edges of the sample opening 62 to prevent a sample on or in the sample collector 26 from engaging an exterior of the housing 36 and / or being removed from the sample collector 26.

[0130] The reactant array 18 may be located in the compartment(s) 20 of the container 13. In some examples, the reactants 58 of the reactant array 18 may be on or supported by a substrate 56. Alternatively or additionally one or more reactants 58 may be located on an interior surface of the housing 36 of the container 13, such that the interior surface may be consitered a substrate for the reactants.Atty. Docket No. 1519.1015111

[0131] The substrate 56 may include and / or may be formed from any suitable material. Example suitable materials used for the substrate 56 supporting the reactant array 18 include, but are not limited to, polymers, optical polymers, optical glasses, plastic, rubber, glass, paper, fdter material, filter paper, fabric, metal, aluminum, polypropylene, polytetrafluorethylenes, porous membranes, chromatography plates, acrylic (e.g., poly(methyl methacrylate) (PMMA)), polycarbonate (PC), polystyrene (PS), non-reactant materials, other suitable materials, and / or combinations thereof. Further, the material utilized for the substrate 56 may be a solid material, a woven material, a hydrophobic material, a gas permeable material, a gas impermeable material, other suitable materials, and / or combinations thereof.

[0132] The window 34 may have any suitable configuration to facilitate viewing and / or imaging the reactant array 18 for analysis. For example, the window 34 may be a transparent portion in the housing 36 formed from glass, polymer, and / or other suitable transparent material through which the reactant array may be viewed or imaged and / or through which light may be collected. The window 34 may be rectangular, circular, the shape of the container 13, and / or other suitable shape.

[0133] FIG. 5 is a schematic perspective view of an illustrative configuration of a sampling device 16 configured to collect a sample from a female patient in a non-invasive manner. In some examples, the sampling device 16 may include a grasping portion or handle 68 coupled with the sample collector 26 via a shaft 70. In some examples, the handle 68 may also be the cover 22 configure to engage or couple with the container 13 to close the sample opening 62 of the container 13 and / or to maintain the sample collector 26 within the compartment(s) of the container 13.

[0134] The shaft 70 may be any suitable type of shaft. In some examples, the shaft 70 may be elongated and rigid such that a distance between the handle 68 and the sample collector 26 may be maintained to prevent or mitigate inadvertent user contamination of the sample collector 26. Other configurations of the shaft 70 are contemplated. In some examples, the shaft 70 may be omitted.

[0135] The sample collector 26 may have any suitable configuration. For example, the sample collector may be or include one or more of a swab, a pad, and / or other suitable instrument configured to minimize invasiveness when obtaining a sample with the sample collector 26. In some examples, the shaft 70 may be part of the sample collector 26 by havingAtty. Docket No. 1519.1015111a tubular structure defining a lumen configured to receive a portion of a sample via negative pressure extending through the lumen.

[0136] FIGS. 6A and 6B are schematic perspective views of the sampling device 16 and the container 13 of the detector 12 being coupled to one another. As depicted in FIG. 6A, the sample collector 26 may be used to break the seal 64 (e g., via the perforation 66 or other suitable seal breaking feature) and may be inserted into the compartment(s) 20 via the sample opening 62.

[0137] With the sample collector 26 within the compartment 20 of the container 13, the cover 22 may close the sample opening 62. In some examples, the cover 22 may create a hermetic seal with the housing 36 of the container 13, but other suitable configurations are contemplated.

[0138] With the sample collector 26 within the compartment 20, the cover 22 may be coupled with the housing 36 of the container 13 to maintain the sample collector 26 in a desired position within the compartment. In some examples, the cover 22 may coupled with the housing in any suitable manner including, but not limited to, via threads, one or more mating features, one or more latches, magnets, negative pressure, and / or other suitable coupling features or components. The coupling between the cover 22 and the housing 36 may or may not be reversible.

[0139] The sample collector 26 may be placed at any suitable location within the compartment 20 relative to the reactant array 18. In some examples, the sample collector 26 may be configured to be positioned within the compartment(s) 20 at a location spaced from the reactants 58 of the reactant array 18 to ensure the sample does not directly contact the reactants 58 and mitigate a likelihood of contaminating the reactants 58. In some examples, the sample collector 26 may be flexible so as to be configured to contact an inner surface to spread out the sample creating a larger surface area from which the volatiles can emanate. In some examples, the sample collector 26 may be configured to contact / mix with reagents and / or catalysts (e.g., chemistries, solvents, tryptic soy agar, etc .) within and / or on an inner surface / location / structure of the container 13 and / or the sample collector 26 to facilitate / enhance detectability of the analytes. In some examples, the sampling device 16 may be configured to be inserted into the container 13 such that the sample collector 26 is positioned within the compartment(s) on an opposite side of the substrate 56 from a side of the substrateAtty. Docket No. 1519.101511156 at which the reactants 58 are located. Other suitable configurations for positioning the sample collector 26 relative to the reactant array 18 are contemplated.

[0140] FIG. 7 is a schematic perspective view of an illustrative configuration of the detector 12. As depicted in FIG. 7, the detector 12 may take on a general three-dimensional rectangular configuration. The detector 12 may include the container 13 coupled with the sampling device 16, where the cover 22 may be coupled with the housing 36 of the container 13 and closing the sample opening 62 (not shown in FIG. 7).

[0141] The container 13 may include a first compartment 20a and a second compartment 20b. The first compartment 20a may be in fluid communication with the second compartment 20b.

[0142] The sampling device 16 may be configured to be inserted into the container 13 and coupled with the container 13 such that the sample collector 26, and the shaft 70 when included, may be inserted into the first compartment 20a. With the second compartment 20b housing the reactant array 18, the sample on the sample collector 26 may be spaced from and / or isolated from the reactants 58 of the reactant array. In some examples, liquid barrier (e.g., hydrophobic barrier) may extend between the first compartment 20a and the second compartment 20b to allow gasses to transfer between the first compartment 20a and the second compartment 20b, but not liquids. Other suitable configurations of the compartments 20 are contemplated.

[0143] FIGS. 8A is a schematic perspective view of the sampling device 16 and the container 13 of the detector being coupled to one another. FIG. 8B is a schematic end view of the detector 12 with the sampling device 16 coupled with the container 13.

[0144] The illustrative configuration of the detector 12 depicted in FIGS. 8A and 8B may include, among other suitable components, the container 13, the sampling device 16 including the handle 68, the shaft 70, and the sample collector 26. In some examples, the housing 36 of the container 13 may have a pot configuration with an open top defining the sample opening 62. In some examples, the container 13 may or may not have a seal extending across the sample opening 62.

[0145] The handle 68 of the sampling device 16 may be configured as the cover 22. In some examples, a side of the handle 68 or cover 22 configured to face the compartment 20 of the container 13 and be in fluid communication with the compartment 20 when the sampling device 16 is coupled with the container 13, may contain the reactant array 12 having a pluralityAtty. Docket No. 1519.1015111of reactants 58. As such, the reactant array 18 may be fluidly exposed to an interior of the compartment 20 in which the sample collector 26 and the sample thereon are located sealed when the handle 68 and / or the cover 22 are coupled with the housing 36 of the container 13 to close and / or seal the compartment(s) 20.

[0146] A breakable seal 72 may cover the reactant array 18 on the handle 68 and / or cover 22. The breakable seal 72 may prevent the reactant array 18 from exposure to one or more contaminants prior to the handle 68 and / or the cover 2 engaging the container 13 and / or prior to a desired time for sensing analytes. When broken, the breakable seal 72 may allow the reactant array 18 to be exposed to the analytes from a sample. As the handle 68 and / or cover 22 is coupled with the container 13, the breakable seal 72 may engage the container 13 or a component of the container 13 and break open such that the reactant array 18 may be exposed to the fluid in the compartment(s) within the container 13 after the handle 68 and / or the cover 22 is coupled with the container 13 to expose the reactants 58 of the reactant array 18 with analytes from the sample.

[0147] The housing 36 of the container 13 may have a transparent (e.g., optically transparent) bottom or distal end as depicted in the bottom view of the detector 12 in FIG. 8B. In some examples, the entirety of the container 13 may be transparent, but other suitable configurations are contemplated. When the housing 36 has a transparent portion (e.g., the bottom surface of the container 13, which may act as the window 34), the reactant array 18 may be viewed and / or imaged from the bottom of the container 13 for analysis.

[0148] In operation, the sampling device 16 may be used to collect a sample from the female subject and the sample collector 26 with the sample thereon may be inserted into the container 13. In some examples, the female subject may be the user obtaining the sample, which may help minimize the invasiveness of obtaining the sample. With the sample collector 26 in the vessel, the handle 68 and / or the cover 22 may be coupled with the container 13 to close the compartment 20 and expose the reactant array 18 to analytes from the sample on the sample collector 26 in an environment sealed from the ambient. The reactant array may then viewed and / or imaged for analysis through the bottom of the container 13.

[0149] FIG. 9 depicts a schematic diagram of an illustrative method 100 for detecting vaginal infections in female subject. The method 100 may include any suitable devicesAtty. Docket No. 1519.1015111including, but not limited to, the detectors 12 and the reader devices 14 configured to analyze reactant arrays 18 of the detector 12 discussed herein.

[0150] The method 100 may include obtaining 102 a biological sample from a vaginal region of a subject. In some examples, a user (e.g., the female subject, a physician, etc.) may use a sampling device with a sample collector to obtain the sample from the vaginal region. In one example, the sampling device may be a swab and obtaining the biological sample may include swabbing the vaginal region to collect vaginal fluid from the female subject.

[0151] The method 100 may include placing 104 the biological sample in a container configured to be in fluid communication with a reactant array. Once the biological sample has been obtained using the sampling device, the sample collector of the sampling device may be positioned within a compartment of a housing of the container. In some examples, a reactant array may be positioned in the housing of the container and may be in fluid communication with the sample.

[0152] The method 100 may include sealing 106 the container with a cover. In some examples, the cover that seals the container may be a coverthat includes the reactant array, but other suitable configurations are contemplated. In some examples, the cover may seal the compartment housing the sample such that the fluid from the sample may interact with reactants of the reactant array.

[0153] The reactant array may be located on a cover of the container and the cover may be coupled with the housing of the container after the sample is in the container to place the reactant array in fluid communication with the sample. In some examples, a protective seal may extend over the reactant array on the cover and the protective seal may be broken in response to engaging the cover with the container to seal the container. Such a protective seal may ensure the reactant array is not exposed to fluid until the cover is sealed on the container to place the sample and the reactant array in fluid communication.

[0154] The method 100 may include analyzing 108 one or more changes in the reactant array resulting from analytes emitted from the sample in the compartment of the container. In some examples, color changes and / or other suitable changes of the reactants of the reactant array may be monitored and analyzed over time. For example, the reactant of the reactant array may be compared before, during, and / or after to one another to analyze the reactant array to determine one or more parameters or conditions of the sample and / or the subject providingAtty. Docket No. 1519.1015111the sample. In some examples, analyzing the changes may include observing the reactant array for one or more present or not present indications for one or more analytes or conditions.

[0155] Analyzing changes in the reactant array may identify any suitable analytes present in the sample and / or conditions that the subject may or may not have. In some examples, analyzing the one or more changes in the reactant array may include detecting analytes emitted from the biological sample that are associated with at least one of Gardnerella vaginalis, Bacterial vaginosis, Candida albicans, Trichomonas vaginalis, and / or other conditions.

[0156] The changes in the reactant array may be compared to known data to determine which analytes may be present in the sample and / or which conditions the subject may or may not have. In one example, analyzing the changes in the reactant array may include comparing the reactant array (e.g., changes in the reactant array) after exposure to fluid from the sample to a set of one or more test images indicative of how the reactant array would appear if the reactants of the reactant array are exposed to one or more particular analytes and / or the subject has one or more conditions. In one example, a visual mask may be overlaid on the container and a user may be able to compare the reactants of the reactant array to the visual mask to determine which analytes are present the in sample and / or which conditions the subject may or may not have.

[0157] Analyzing the changes in the reactant array may be done by a human observer via visual inspection. Alternatively or additionally, one or more images of the reactant array may be captured and analyzed by human visual inspection or computer vision inspection via computer image processing system.

[0158] When a reader device is utilized with computer vision inspection capabilities or other light analysis systems, the reader device may be configured to output quantitative data or information about one or more analytes or microorganisms present in the sample. Quantitative data or information may include, but is not limited to, parts per million information, whether an amount of an analyte is above or below a threshold, and / or other suitable quantitative data or information.

[0159] When a reader device is utilized to analyze the reactant array, the reader device may be configured to monitor the response of a subject to a treatment. For example, the reader device may compare analyses of multiple analyses of reactants exposed to samples of a subject over time spanning from before a treatment was applied to subject or after a first treatment wasAtty. Docket No. 1519.1015111applied to the subject to a subsequent time to determine the efficacy the treatment. In other words, the reader device may keep an analyte profile for the subject and monitor changes over time, while noting treatments applied to the subject and / or other changes the subject may experience.

[0160] As discussed, the reactant array may be analyzed by a reader device remote from the container. For example, after a predetermined time period after sealing the container with the cover, the container may be unsealed and the reactant array may be analyzed by a reader device remote from the container to determine which analytes were present in the sample and / or which conditions the subject may or may not have.

[0161] In addition to the configurations described herein, a sample collected from the female using the sampling device 16 and may be placed in the compartment 20 of the container 13, which may include an adsorbent material (e.g., polydimethylsiloxane (PDMS), etc.) therein. Adsorbent material may be configured to adsorb analytes from the sample in the container 13. The adsorbent material may or may not be or include the reactant array 18 and the adsorbent material may be analyzed with a gas chromatograph-mass spectrometer (GC-MS) and / or other suitable analysis system. Alternatively or additionally, the reactant array 18 and / or the adsorbent material may be analyzed with one or more other remote analysis systems and / or visually with a naked eye of a user. In some examples, the remote analysis system may be a mobile device (e.g., phone, laptop, tablet, etc ), a cartridge or detector (e.g., with a sample to be analyzed inserted in the cartridge or detector), a reader device, and / or other suitable remote analysis system. Examples of remote analysis systems configured as detectors and / or reader devices are disclosed in PCT Application No. PCT / US2023 / 083024, filed on December 8, 2023, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2023 / 83063, filed on December 8, 2023, titled DEVICES, METHODS, AND SYSTEMS TO MEASURING AND RECORDING SPECTRUM OF A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2023 / 083076, filed on December 8, 2023, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No.Atty. Docket No. 1519.1015111PCT / US2023 / 083104, filed on December 8, 2023, titled REACTANT ARRAY DEVICE, SYSTEMS, AND METHODS, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2023 / 083073, filed on December 8, 2023, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2023 / 083068, filed on December 8, 2023, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2024 / 058789, filed on December 6, 2024, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2024 / 058796, filed on December 6, 2024, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes; PCT Application No. PCT / US2024 / 058809, filed on December 6, 2024, titled DEVICES, METHODS, AND SYSTEMS FOR MEASURING AND RECORDING A REACTANT ARRAY, which is hereby incorporated by reference in its entirety for any and all purposes.

[0162] It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in detail, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.

Claims

Atty. Docket No. 1519.1015111ClaimsWhat is claimed is:

1. A device for detecting vaginal infections, comprising:a container;a reactant array disposed within the container;a sampling device; anda cover coupled with the sampling device and configured to engage the container and seal the sampling device within the container,wherein the reactant array is configured to detect analytes emitted from a sample on the sampling device and change based on the analytes detected.

2. The device of claim 1, wherein the container comprises an optical window aligned with the reactant array.

3. The device of claim 2, wherein the cover is configured to position the sampling device at a predetermined location within the container relative to the reactant array and the optical window.

4. The device of any one of claims 1-3, wherein the sampling device comprises at least one of a swab, spatula, pipette, eye dropper, cytobrush, Pipelle, curette, or brush.

5. The device of any one of claims 1-4, wherein the reactant array comprises multiple reactants that change upon exposure to different analytes.

6. The device of any one of claims 1-5, wherein the reactant array is disposed on a porous substrate within the container.

7. A method for detecting vaginal infections, comprising:obtaining a biological sample from a vaginal region of a subject;placing the biological sample in a container configured to be in fluid communication with a reactant array;Atty. Docket No. 1519.1015111sealing the container with a cover; andanalyzing one or more changes in the reactant array resulting from analytes emitted from the biological sample.

8. The method of claim 7, wherein obtaining the biological sample comprises swabbing the vaginal region to collect vaginal fluid.

9. The method of claim 7 or claim 8, wherein analyzing the changes comprises visual inspection of the reactant array.

10. The method of any one of claims 7-9, wherein analyzing the changes comprises using a computer image processing system.

11. The method of any one of claims 7-10, further comprising comparing the one or more changes in the reactant array to a set of test images of the reactant array.

12. The method of any one of claims 7-11, wherein analyzing the changes comprises using a visual mask overlaid on the container.

13. The method of any one of claims 7-12, further comprising:after a predetermined time period after sealing the container with the cover, removing the reactant array from the container,wherein analyzing the one or more changes of the reactant array is performed with a reader device remote from the container.

14. The method of any one of claim 7-13, wherein analyzing one or more changes in the reactant array comprises detecting analytes emitted from the biological sample associated with at least one of Gardnerella vaginalis, Candida albicans, Bacterial vaginosis, or Trichomonas vaginalis.

15. A system for detecting vaginal infections, comprising:Atty. Docket No. 1519.1015111a sampling device configured to collect a biological sample from a vaginal region of a subject;a container containing a reactant array;a cover configured to seal the container; anda reader device configured to process changes in the reactant array resulting from analytes emitted from the biological sample.

16. The system of claim 15, wherein the reader device is configured to provide quantitative information about microorganisms present in the biological sample.

17. The system of claim 15 or claim 16, wherein the system is portable and configured for point-of-care use.

18. The system of any one of claims 15-17, wherein the sampling device comprises a swab and is coupled with the cover.

19. The system of any one of claims 15-18, wherein the reader device is configured to monitor a response to treatment of a detected condition of the subject based on changes in analyte profiles over time.

20. The system of any one of claim 15-19, wherein the system is configured to detect specific analytes associated with at least one of Gardnerella vaginalis, Candida albicans, Bacterial vaginosis, or Trichomonas vaginalis.

Images