Light Box System for Optical Assay Testing

Abstract

Aspects of the present disclosure relate to a light box that can improve imaging of point-of-care test devices. In one aspect, a disposable light box can also serve as packaging for the test device. In one aspect, the light box includes an integrated light source. In one aspect, a PTFE layer can be applied to the interior surface of the light box to improve light distribution to the top surface of a test device received within the light box.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 379,876, filed October 17, 2022, and U.S. Provisional Patent Application No. 63 / 519,808, filed August 15, 2023, which are incorporated by reference in their entireties.

[0002] [Technical field] FIELD OF THE DISCLOSURE This disclosure relates to analyte testing, and more particularly to point-of-care diagnostic testing and imaging. [Background technology]

[0003] Test analytical information can be obtained from images of a test device, such as a lateral flow assay or other cartridge-based test. Determining analytical information based on image analysis can be subject to errors due to color management, registration, image distortion, and other sources of error in the captured image. For example, such methods can result in reading errors, such as false negative results, due to poor image quality (high noise levels, poor lighting, poor focus, high motion blur, etc.) and / or algorithmic errors (incorrect homography, improper normalization, etc.).

[0004] Furthermore, many optical diagnostic tests, such as colorimetric and reflectometric signal inspection, rely on relatively diffuse and uniform illumination to enable accurate signal readings. Even as smartphone cameras begin to be used to read test equipment, illumination remains dominated by ambient room light. Analysis of images captured by smartphone and other mobile device cameras can be particularly prone to error. Summary of the Invention

[0005] To reduce the likelihood of errors in image-based test analysis systems, imaging systems for test analysis are typically operated in tightly controlled environments and carefully calibrated and normalized. Controlling the imaging environment is a challenge for point-of-care testing, where users may not have the necessary equipment to obtain consistent, high-quality images. The light box of the present disclosure can ensure consistent and reproducible imaging conditions.

[0006] In one non-limiting embodiment, a light box for imaging a diagnostic test device is provided, the light box comprising a box structure configured to package the diagnostic test device prior to use of the diagnostic test device, the box structure having a plurality of side walls and a top surface defining an interior volume, and at least one opening in the top surface, the at least one opening configured to allow a mobile device to image the diagnostic test device through the opening while the diagnostic test device is disposed within the interior volume.

[0007] The light box may further include a carriage sized and shaped to fit within the interior volume of the light box and configured to facilitate positioning of the diagnostic test device within the light box for imaging by the mobile device. The carriage may include an adhesive configured to secure the diagnostic test device to the carriage. The carriage may include at least one alignment mark identifying a mounting position of the diagnostic test device on the carriage.

[0008] The at least one opening may include a transparent window, and the mobile device may be at least partially placed on the transparent window. The top surface of the light box may be configured to support the mobile device while the mobile device images the diagnostic test device through the opening. The light box may further include a polytetrafluoroethylene (PTFE) polymer coating on at least one interior surface of the box structure. The at least one opening may be sized and shaped to accommodate simultaneous image capture by a camera of the mobile device and illumination of the diagnostic test device by a light emitter of the mobile device. The at least one opening of the light box may include a first opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model mobile device having a first camera and flash configuration, and a second opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model mobile device having a second camera and flash configuration. The top surface of the light box may have at least one alignment mark identifying a placement position of the mobile device on the top surface. The light box may further include a light diffuser positioned above or below the opening. The light diffuser may be attached to a bottom surface of a transparent window at least partially covering the opening. The light box may further include a removable protective cover covering at least a portion of the opening. The light box may be configured to be foldable between a shipping configuration and an imaging configuration, the shipping configuration may have a first height and the imaging configuration may have a second height greater than the first height, the second height may correspond to an imaging focal length of the mobile device. The top surface of the light box may be recessed from a top surface of the box structure, and the top surface may be configured to receive and hold the mobile device.

[0009] In another non-limiting example, a method for imaging a test device is provided that may include deploying a light box with an aperture from a shipping configuration to an imaging configuration, placing a test device within the light box in the imaging configuration, and imaging the test device using a mobile device.

[0010] The method may further include removing a cover from the opening of the light box. The method may further include aligning a camera of the mobile device with the opening. The method may further include aligning the test device with the opening. The method may further include placing the mobile device on a surface of the light box. Placing the test device in the light box may include placing the test device on a carriage and inserting the carriage into the light box. The method may further include adhering the test device to the carriage. In the imaging configuration, the light box may have a height equal to or greater than a focal length of the mobile device.

[0011] In yet another non-limiting embodiment, a light box for imaging a diagnostic test device is provided, which may include a box structure having at least one opening and a plurality of light sources positioned within an interior volume of the box structure, the at least one opening configured to allow a mobile device to image the diagnostic test device from a predetermined distance.

[0012] The light source may include a plurality of LEDs. The light source may include one or more LED strips. The plurality of LEDs may include one or more first LEDs configured to emit a first set of wavelengths and one or more second LEDs configured to emit a second set of wavelengths different from the first set of wavelengths. The plurality of LEDs may include a first plurality of LEDs arranged along a first interior side of the light box and a second plurality of LEDs arranged along a second interior side of the light box opposite the first interior side.

[0013] The light box may further include a third plurality of LEDs disposed along a third interior side of the light box and a fourth plurality of LEDs disposed along a fourth interior side of the light box.

[0014] The light box may further include a diffuser configured to diffuse light from the light source into the light box. The diffuser may have a tray shaped and sized to receive the diagnostic test device in alignment with an imaging area. The tray may include frosted plastic. The tray may include thermoformed plastic or 3D printed plastic.

[0015] The LEDs may be positioned to face downward at an angle between 15° and 85° relative to the vertical. The LEDs may be positioned to face downward at an angle of 45° relative to the vertical. The spacing between adjacent LEDs may be approximately 1 cm. The box structure may have side walls and a top surface defining the interior volume. The at least one opening may be provided in the top surface and configured to allow the mobile device to image the diagnostic test device through the at least one opening while the diagnostic test device is disposed within the interior volume. The box structure may have a base and a lid, and the at least one opening may be provided in a top surface of the lid. The box structure may be configured to receive the diagnostic test device within the base when the lid is removed from the box structure. The box structure may be configured to receive the diagnostic test device through an opening in a side wall of the box structure.

[0016] In yet another non-limiting embodiment, a light box for imaging a diagnostic test device is provided, the light box comprising a box structure configured to deploy from a shipping configuration to an imaging configuration for use with the diagnostic test device, the box structure having a plurality of side walls and a top surface defining an interior volume, and at least one opening in the top surface, the at least one opening configured to allow a mobile device to image the diagnostic test device through the opening while the diagnostic test device is disposed within the interior volume.

[0017] The light box may further include a carriage sized and shaped to fit within the interior volume of the light box and configured to facilitate positioning of the diagnostic test device within the light box for imaging by the mobile device. The carriage may include an adhesive configured to secure the diagnostic test device to the carriage. The carriage may include at least one alignment mark identifying the mounting position of the diagnostic test device on the carriage. The at least one opening may include a transparent window, and the mobile device may be at least partially mounted on the transparent window. The top surface of the light box may be configured to support the mobile device while the mobile device images the diagnostic test device through the opening. The light box may further include a polytetrafluoroethylene (PTFE) polymer coating on at least one interior surface of the box structure. The at least one opening may be sized and shaped to simultaneously accommodate image capture by the mobile device camera and illumination of the diagnostic test device by the mobile device light emitter. The at least one opening may include a first opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model mobile device having a first camera and flash configuration, and a second opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model mobile device having a second camera and flash configuration. The top surface of the light box may include at least one alignment mark identifying the placement of the mobile device on the top surface. The light box may further include a light diffuser positioned above or below the opening. The light diffuser may be attached to a bottom surface of a transparent window at least partially covering the opening. The light box may further include a removable protective cover covering at least a portion of the opening. The shipping configuration may have a first height, and the imaging configuration may have a second height greater than the first height, the second height corresponding to an imaging focal length of the mobile device.The top surface of the light box may be recessed from a top surface of the box structure, and the top surface may be configured to receive and hold the mobile device.

[0018] In any of the foregoing non-limiting embodiments, the box structure may be reusable.

[0019] In any of the foregoing non-limiting embodiments, the box structure may be disposable.

[0020] In any of the foregoing non-limiting embodiments, the diagnostic test device may be disposed within the interior volume of the light box.

[0021] In any of the foregoing non-limiting embodiments, the light box may be the shipping container for the diagnostic test device.

[0022] Features, aspects, and advantages of embodiments of the present disclosure will now be described in conjunction with various implementations with reference to the accompanying drawings. The illustrated implementations are merely exemplary and are not intended to be limiting. [Brief explanation of the drawings]

[0023] [Figure 1A] 1A and 1B show an exemplary disposable light box according to the present disclosure that includes two windows for interfacing with different models of mobile devices. [Figure 1B] 1A and 1B show an exemplary disposable light box according to the present disclosure that includes two windows for interfacing with different models of mobile devices.

[0024] [Figure 1C] FIG. 1C illustrates a removable carriage for the exemplary disposable light box shown in FIGS. 1A and 1B.

[0025] [Figure 1D]1D and 1E show exemplary mobile devices that may be used with the disposable light box. [Figure 1E] 1D and 1E show exemplary mobile devices that may be used with the disposable light box.

[0026] [Figure 2] FIG. 2 shows an exemplary disposable light box with a mobile device positioned to image a test cartridge.

[0027] [Figure 3] FIG. 3 shows a perspective view of an exemplary light box with an integrated light source and a mobile device positioned to image a test cartridge.

[0028] [Figure 4A] FIG. 4A shows a cross-sectional view of an exemplary light box including a tray for positioning light sources.

[0029] [Figure 4B] FIG. 4B shows a top view of an exemplary light box.

[0030] [Figure 4C] FIG. 4C shows an exemplary light box and illustrates the positioning of the light source within the light box.

[0031] [Figure 5] FIG. 5 shows an exemplary light box with an integrated light source.

[0032] [Figure 6] FIG. 6 plots the light intensity along the bottom surface of an exemplary light box for three different distances between light source strips and two light source intensities.

[0033] [Figure 7]FIG. 7 plots the light intensity along the bottom of an exemplary light box for two-edge and four-edge light configurations.

[0034] [Figure 8A] FIG. 8A shows an exemplary light box with a diffusion tray.

[0035] [Figure 8B] FIG. 8B plots the light intensity along the bottom surface of an exemplary light box with a diffusing tray for two-edge light source configurations and four-edge light source configurations.

[0036] [Figure 9] FIG. 9 shows an exemplary light box with a four edge light source configuration.

[0037] [Figure 10] FIG. 10 shows an exemplary diffusion tray.

[0038] [Figure 11A] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box. [Figure 11B] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box. [Figure 11C] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box. [Figure 11D] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box. [Figure 11E] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box. [Figure 11F] 11A-11F show an exemplary diffusion tray with light sources mounted on the outside and inside of the light box.

[0039] [Figure 12A] FIG. 12A shows a schematic representation of a Lambertian reflection.

[0040] [Figure 12B] FIG. 12B shows the transmittance, absorptance, and reflectance of sintered polytetrafluoroethylene (PTFE) over the optical wavelength range of 250 nm to 500 nm.

[0041] [Figure 13] FIG. 13 plots the reflectance of sintered PTFE as a function of average pore size.

[0042] [Figure 14A] FIG. 14A shows a plan view of an exemplary light box with a window that interfaces with a smartphone positioned to photograph a test cartridge within the light box and is illuminated by the smartphone's built-in flash LED.

[0043] [Figure 14B] FIG. 14B shows an image of the test cartridge taken in the exemplary light box of FIG. 14A, the interior of which is covered with white paper, and a plot showing the illumination profile along the long axis of the rectangle drawn below the image.

[0044] [Figure 14C] FIG. 14C shows an image of a test cartridge taken in the exemplary light box of FIG. 14A, the interior surface of which is covered with sintered PTFE, and a plot showing the illumination profile along the long axis of the rectangle drawn below the image.

[0045] [Figure 15A] 15A-15C show an exemplary light box with a sintered PTFE layer on the interior surface. [Figure 15B] 15A-15C show an exemplary light box with a sintered PTFE layer on the interior surface. [Figure 15C] 15A-15C show an exemplary light box with a sintered PTFE layer on the interior surface. DETAILED DESCRIPTION OF THE INVENTION

[0046] Embodiments of the present disclosure relate to systems and techniques for detecting analytes that may be present in biological or non-biological samples, such as bodily fluids. Analytes of interest may include any detectable substance, such as, but not limited to, antibodies, proteins, haptens, nucleic acids, amplicons, hormones, and harmful or harmless drugs or contaminants, such as anti-tumor drugs used in cancer treatment. Throughout this disclosure, exemplary systems, devices, and methods are described with reference to collecting, testing, and detecting analytes, such as those associated with diagnostic tests related to infectious diseases, but the technology may be used to collect, test, and detect any particle, molecule, or analyte of interest. The test strips, cartridges, and devices described herein may be configured for performing diagnostic and / or non-diagnostic tests. In some embodiments, embodiments of the present disclosure may be implemented in combination with systems such as the BD Veritor system for rapid detection of SARSCoV-2, the BD Veritor system for rapid detection of influenza A+B, the BD Veritor system for rapid detection of respiratory syncytial virus (RSV), the BD Veritor system for rapid detection of group A streptococcus, (other) BD Veritor systems, the BD Veritor Plus system, and / or components or operations thereof.

[0047] A light box can ensure consistent and reproducible imaging conditions. Ensuring consistency of imaging conditions may be desirable for imaging point-of-care test strips, cartridges, and / or devices. Mobile devices, such as cell phones, are increasingly equipped with high-quality cameras, and such mobile devices can be used to perform imaging of point-of-care assays. Disclosed herein is a light box that can be used with a mobile device to improve imaging of an assay. Also disclosed herein is a light box that can be shipped with test strips, cartridges, and / or devices. Also disclosed herein is a light box that can be discarded (disposable) after one or several uses. Also disclosed herein is a light box that can be used with a mobile device that has an integrated light source. Also disclosed herein is a light box that can be used with a mobile device that includes components for diffusing light emitted by those light sources. Furthermore, disclosed herein is a sintered PTFE coating that can be used within the light box generally and can be particularly useful for any of the light boxes disclosed herein, such as to help create diffuse lighting conditions for imaging.

[0048] Using an integrated (built-in) camera of a mobile device, such as a smartphone, as a reader for an optical diagnostic test assay may be desirable because such cameras are commonly available and produce increasingly high-quality images. Many approaches require a user to manually align the mobile device's camera (e.g., by holding the mobile device over the test device) laterally and axially with the test device to capture the correct region of interest at the correct focal length. However, such approaches do not adequately control ambient lighting, which can interfere with acquisition of optical signals from the test device.

[0049] Ambient light illumination can vary widely in intensity and spectral profile, making it impossible to avoid shadows and lighting artifacts. To improve the usability of mobile devices, such as smartphones, the mobile device's on-board light source (e.g., flash LED) can be used to provide a consistent and controllable source of illumination. However, in some embodiments, it may be desirable to diffuse the light from such light sources to illuminate the test fixture without creating shadows, glare, lighting artifacts, or other conditions that could degrade image quality. Integrating a low-profile light diffuser into the light box can allow the interfaced mobile device to act as both a light source and an image acquisition module.

[0050] Some existing devices clip onto smartphones and cover the camera and flash (light source) to enhance the smartphone's ability to read test devices (which may include diagnostic assays). However, such devices have limited compatibility with smartphone models and only fit smartphones of certain shapes and sizes. Furthermore, some existing devices use a single point light source. Such devices may require factory calibration. Some existing devices do not have a diffuser for uniform distribution of light. The single point light source and lack of a diffuser can result in lighting environments with steep lighting gradients that may not be suitable for imaging test devices.

[0051] Additionally, it is desirable to properly spatially align the test device with the camera to ensure that the region of interest is captured and to maintain a proper focal length between the camera and the test device.

[0052] The devices according to the present disclosure can reduce alignment difficulties, standardize lighting conditions, and minimize the effects of shadows. The disposable light boxes disclosed herein can incorporate alignment markers, test device holders, and appropriate dimensions into a low-cost light box that can also serve as product packaging, thus reducing costs and reducing or eliminating the need for additional accessories.

[0053] [Light Box] In one aspect, the present disclosure relates to a box for physically interfacing a mobile device (e.g., a smartphone, tablet, or other mobile device capable of capturing images) to a point-of-care assay for signal interrogation and image capture, as shown in FIGS. 1A-1C and 2. FIGS. 1A and 1B illustrate a light box 100. FIG. 1C illustrates a diagram of a carriage that may be inserted into the light box 100. FIGS. 1D and 1E illustrate an exemplary mobile device that may be used with the light box 100. The light box 100 includes a box structure 102, a surface 104, mobile device placement marks 106A, 106B, removable covers 108A, 108B, pull tabs 110A, 110B, a panel 112, windows 114A, 114B, diffusers 116A, 116B, and openings 118A, 118B. The light box may also include a test cartridge carriage 120. Test cartridge carriage 120 may include adhesive (sticky) pads 122A, 122B. Figure 1A shows light box 100 in an initial configuration with removable covers 108A, 108B not removed, while Figure 1B shows light box 100 with removable covers 108A, 108B removed to expose openings 118A, 118B with windows 114A, 114B and diffusers 116A, 116B.

[0054] The light box 100 may include a light diffuser 116A that may widen and / or diffuse concentrated light from a mobile device light source 126, such as a flash LED, of the mobile device 130A. The light box 100 may include an opening 118A that includes a transparent window 114A to allow image capture. The light box 100 may include a light diffuser 116B that may widen and / or diffuse concentrated light from a mobile device light source 126, such as a flash LED, of the mobile device 130B. The light box 100 may include an opening 118B that includes a transparent window 114B to allow image capture. The transparent window 114A may be protected by a removable cover 108A of the box 100. The transparent window 114B may be protected by a removable cover 108B of the box 100. The removable cover 108A may include a pull tab 110A. The removable cover 108B may include a pull tab 110B. Mobile device placement marks 106A, 106B on top surface 104 may be provided to allow a user to properly position a particular model of mobile device 130A, 130B. This may ensure alignment of the mobile device's camera 128 and light source 126 with the integrated transparent windows 114A, 114B and light diffusers 116A, 116B. Mobile device placement mark 106A, removable cover 108A, pull tab 110A, window 114A, diffuser 116A, and opening 118A may be used with mobile device 130A. Mobile device placement mark 106B, removable cover 108B, pull tab 110B, window 114B, diffuser 116B, and opening 118B may be used with mobile device 130B.

[0055] A removable test cartridge carriage 120 may be installed within the box 100. The carriage 120 may be removed and inserted via a retractable panel 112. The test cartridge carriage 120 may include test device alignment marks 124A, 124B for proper placement of the test cartridge on the carriage 120, depending on the particular model of mobile device. Adhesive strips 122A, 122B may also be provided on the carriage 120 to immobilize (secure) the test strips, cartridges, and / or devices to the carriage 120. The adhesive pad 122A and test device alignment mark 124A are used with mobile device 130A. The adhesive pad 122B and test device alignment mark 124B are used with mobile device 130B.

[0056] [Light Box Overview] In some embodiments, light box 100 may be a disposable light box. In some embodiments, light box 100 may function as both product packaging for test equipment and as a low-cost light box structure. In some embodiments, light box 100 may function as both a shipping container for test equipment and as a low-cost light box structure. Box 100 may be disposable and / or reusable for analysis of multiple tests. In some embodiments, box 100 may be a flat, collapsible box that a user can unfold into an assembly configuration (also referred to herein as an “imaging configuration”). In such embodiments, the flat, collapsible box may be packaged with test equipment within a shipping box and / or shipping container. When in the assembly configuration, box 100 may support the weight of mobile device 130A and / or 130B placed on top surface 104 of box 100. Box 100 may include adhesive strips to allow a user to secure box 100 in the assembly configuration. In some embodiments, adhesive strips may be positioned at and / or near the corners and / or edges of the box 100 when assembled (unfolded).

[0057] When the test device 202 is positioned on the test cartridge carriage 120 and the test cartridge carriage 120 is inserted into the light box 100, the openings 118A and / or 118B and the transparent windows 114A and / or 114B in the box 100 may allow the mobile device camera 128 to record an image of the test device 202. The openings 118A and / or 118B, the transparent windows 114A and / or 114B, and / or the diffusers 116A and / or 116B may be positioned, sized, and shaped to allow simultaneous image capture by the camera 128 and illumination by the light source 126. When positioned on the top surface 104, the mobile devices 130A and / or 130B may rest at least partially on the transparent windows 114A and / or 114B. The transparent windows 114A, 114B of the box may include light diffusers 116A, 116B (also referred to herein as "diffusers"). A mobile device 130, such as a smartphone, may provide a light source 126, such as a flashing LED or other light source on the mobile device 130, to interrogate the test device. The test device may be an optical assay, such as, but not limited to, a lateral flow assay, a colorimetric assay, and / or a fluorescence-based assay. To provide uniform illumination of the test device, integrated "low-profile" light diffusers 116A, 116B may be incorporated to diffuse the light emitted from the light source 126 (e.g., a flashing LED) on the mobile device 130, spreading the light throughout the test device.

[0058] The diffusers 116A, 116B may be attached to, secured to, and / or embedded in the respective transparent windows 114A, 114B. In some embodiments, the diffusers 116A, 116B may be cast into the respective windows 114A, 114B as a single component, which may include a plastic material. As a non-limiting example, the windows 114A, 114B may be cast from clear plastic, with the respective diffusers 116A, 116B including a Fresnel lens cast into the plastic. The diffusers 116A and / or 116B may be approximately 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, or 2.0 cm. 2 or a surface area equal to or greater than each of these, or any value or range of surface areas defined by any of the foregoing values. In some embodiments, diffusers 116A and / or 116B may have a surface area of ​​about 0.5 cm 2 ~about 1cm 2 Although in some embodiments, the diffusers may have surface areas outside of this range. The area of ​​diffusers 116A and / or 116B may be large enough to capture all, substantially all, or at least a portion of the light emitted by the mobile device light sources 126. Diffusers 116A and / or 116B may be rectangular, circular, or elliptical. In some embodiments, windows 114A, 114B may include multiple diffusers 116A, 116B, respectively. For example, if box 100 is usable with a mobile device 130A that has two or more light sources 126, window 114A may include two or more diffusers 116A, each corresponding to one of the light sources 126.

[0059] In some embodiments, the locations of windows 114A, 114B and diffusers 116A, 116B on box 100 may be specific to one model of mobile device, such as a mobile device, and / or a group of models of mobile devices with similar camera and / or light source configurations. For example, window 114A and diffuser 116A may be specific to mobile device 130A, and window 114B and diffuser 116B may be specific to mobile device 130B. While FIGS. 1A and 1B show two windows 114A, 114B, the box may include one, two, three, four, five, six, seven, eight, nine, ten, or more windows. Each window may include one or more diffusers. It will also be understood that in some non-limiting implementations, window 114 does not include diffuser 116.

[0060] Mobile device placement marks 106A, 106B on the top surface 104 of the box 100 may guide (instruct) a user to align the mobile devices 130A, 130B with the light box 100 so that the mobile device cameras 128 are aligned with the respective transparent windows 114A, 114B. Mobile device placement marks 106A, 106B on the top surface 104 of the box 100 may guide (instruct) a user to align the mobile devices with the light box 100 so that the mobile device light sources 126 are aligned with the respective diffusers 116A, 116B. Such mobile device placement marks 106A, 106B may include, for example, outlines indicating where the mobile devices 130A, 130B should be placed. In some embodiments, the top surface 104 may be recessed from the top surface of the box 100. The top surface may be positioned farther from the test apparatus 202 than the top surface 104. Recessing the top surface 104 from the top surface may assist a user in positioning the mobile device 130. In some embodiments, the top surface may be formed by a layer of material positioned above and attached to the top surface 104. In such embodiments, the top surface may include a cutout area that defines a recess between the top surface 104 and the top surface 104.

[0061] The window 114A and diffuser 116A may be covered and / or overlapped by a perforated removable cover 108A of the box 100. The cover 108A may incorporate a pull tab 110A for easy identification and removal. The window 114B and diffuser 116B may be covered and / or overlapped by a perforated removable cover 108B of the box 100. The cover 108B may also incorporate a pull tab 110B for easy identification and removal. A user may remove the removable covers 108A, 108B from the box 100 by tearing along the perforated edges (perforations) of the removable covers 108A, 108B. The pull tabs 110A, 110B may be bent upward to provide a gripping surface for the user when attempting to remove the removable covers 108A, 108B. The perforated removable cover 108A of the box 100 may function to protect the window 114A and / or the diffuser 116A before imaging the test apparatus. The perforated removable cover 108B of the box 100 may function to protect the window 114B and / or the diffuser 116B before imaging the test apparatus. The perforated removable cover 108A of the box 100 may function to protect the window 114A and the diffuser 116A during shipping (transport) of the box 100 and / or the test apparatus 202. The perforated removable cover 108B of the box 100 may function to protect the window 114B and the diffuser 116B during shipping (transport) of the box 100 and / or the test apparatus 202.

[0062] 1A-2 , it may be desirable to incorporate low-profile light diffusers 116A and / or 116B for use with the mobile device's light source 126 (e.g., a flash LED). As described herein, the diffusers 116A and / or 116B may be capable of spreading light across the test fixture 202, thereby preventing glare in images acquired by the camera 128 and / or uneven distribution of light on the test fixture 202. Many different materials may be suitable for incorporation within the diffusers 116A and / or 116B, such as fiber / paper or plastic, particularly low-cost plastics. In some embodiments, the diffusers 116A and / or 116B may include lenses, such as Fresnel lenses, regularly spaced lenses, or randomly spaced lenses. In some embodiments, the diffusers 116A and / or 116B may include one or more etched surfaces. For example, diffusers 116A and / or 116B may comprise etched plastic or etched glass. The lenses and / or etched surfaces may be implemented with low-cost, thin plastic, depending on the degree of diffusion and light transmission desired within box structure 102 and the particular light source 126. In some embodiments, a fiber-based material (e.g., rice paper) may be included within diffusers 116A and / or 116B.

[0063] 2, to ensure the proper focal distance between the mobile device camera 128 and the inner surface of the bottom of the box structure 102, the test device 202 is mounted on the test cartridge carriage 120, and the height h of the box structure 102 can be matched to either one specific model of mobile device or a general distance that allows the camera of one or more models of mobile device to focus on the test device 202. Furthermore, if the window 114 and alignment marks 124A, 124B (see FIG. 1C) are used, the height h can be combined with the position of the window 114 and diffuser 116 relative to the test device alignment marks 124A, 124B (see FIG. 1C) to ensure that the test device 202 is within the camera field 206 and the diffused light region 208. To reliably image the correct area of ​​the test device 202, the test cartridge carriage 120 (also referred to herein as the “carriage”) is included within the box 100.

[0064] As shown in FIG. 1C , the test cartridge carriage 120 can guide (instruct) the user to properly position the test device 202 using test device alignment marks 124A, 124B specific to the mobile device model. The test cartridge carriage 120 can be removed from the box 100 to allow the user to identify the correct test device alignment mark 124A or 124B and attach the test device 202, for example, by placing the test device 202 on an adhesive pad 122A or 122B. In some embodiments, the carriage 120 can substantially immobilize the test device 202 by positioning the test device 202 on an adhesive pad 122A or 122B included in the test cartridge carriage 120. As an illustrative example, the adhesive pad 122A and / or 122B can include a double-sided adhesive strip. The adhesive pads 122A and / or 122B may prevent or inhibit movement of the test device 202 relative to the test cartridge carriage 120 when the test cartridge carriage 120 is inserted and returned into the box structure 102, or when movement of the box 100 occurs while the test device 202 and carriage 120 are within the box structure 102.

[0065] The carriage 120 may also include printed marks in addition to the alignment marks described herein. The carriage 120 may or may not incorporate scan card functionality. The carriage 120 may be a scan card with printed marks. The printed marks may be used during analysis of a test device placed on the scan card and / or during analysis of images of the test device and scan card. The printed marks may include, but are not limited to, printed reference colors, control marks, image area boundaries, fiducials, and other features. The printed marks may be used to analyze the results of tests performed on the test device and / or the adequacy of lighting, orientation, and focus conditions associated with images of the test device. The following applications describe non-limiting examples of scan cards that may be implemented in accordance with the present disclosure: U.S. patent application Ser. No. 17 / 098,236, entitled "Diagnostic Test Kit for Sample Preparation and Analysis," U.S. patent application Ser. No. 17 / 222,819, entitled "Diagnostic Test Kit and Method for Analysis Thereof," U.S. patent application Ser. No. 29 / 812,505, entitled "Scan Card for In Vitro Assays," and U.S. patent application Ser. No. 29 / 816,279, entitled "Scan Card for In Vitro Assays," each of which is incorporated by reference in its entirety.

[0066] The overall alignment between the windows 114A and / or 114B and the test apparatus 202 may be defined in part by the size of the carriage 120 relative to the box 100. The carriage 120 may be sized to fit within the box 100, and the tightness of the fit may define the stackup tolerance between the test apparatus 202 and the mobile device 130. The tighter the fit, the smaller the gap 204 between the carriage 120 and the inside of the box structure 102. A loose fit between the carriage 120 and the box structure 102 (e.g., a relatively large gap 204) may result in less precise alignment of the carriage 120 within the box, even within the tolerances. On the other hand, a loose fit between the carriage 120 and the box structure 102 may make it easier to remove and insert the carriage 120.

[0067] Alignment of the optical components (optics) may be maintained at least in part by the dimensions and rigidity of box 100 and the incorporation of fiducial marks on test fixture 202 and / or carriage 120. In other words, alignment of mobile device camera 128 and LED light source 126, diffusers 116A and / or 116B, and test fixture 202 may be maintained at least in part by the dimensions and rigidity of box 100 and the use of fiducial marks on test fixture 202. Carriage 120 may also assist in maintaining alignment.

[0068] In some embodiments, the box structure 102 and / or carriage 120 comprise corrugated cardboard, a low-cost, high-strength-to-weight material commonly used in consumer packaging. In some embodiments, the corrugated cardboard may be corrugated if relatively high strength is desired. In some embodiments, the corrugated cardboard may not be corrugated.

[0069] The interior surfaces of the box structure 102 may be coated with or include materials to improve and / or optimize lighting conditions, such as reflected light brightness and / or illumination uniformity. Surface reflectivity and color are primary variables to consider. For example, a reflective coating may maximize interior ambient brightness. As another example, a light matte coating may optimize interior illumination uniformity. Sintered PTFE, described below with reference to FIGS. 12-15C, is an exemplary material that, when incorporated into the box structure 102, may help increase or maximize interior illumination uniformity, resulting in a higher level of interior ambient brightness.

[0070] In some embodiments, a kit includes a test device 202 (which may include a diagnostic assay) and a light box 100. The kit may also include instructions, including instructions for using the test device 202 and / or instructions for using the light box 100 for use with the test device 202 and a mobile device to generate a suitable image.

[0071] [Adapting the light box to different models of mobile devices] Certain characteristics of the box 100 may be specific to each model of the mobile device 130. For example, the specific dimensions and / or shape of the box may correspond to one or more different mobile device models, such as mobile device 130A or mobile device 130B. The overall length and width of the box structure 102 for supporting mobile device 130A and / or 130B may be specific to the model of the mobile device. The positioning of the transparent window 114A and the light diffuser 116A may match (correspond) to the camera configuration of the mobile device and may be specific to a first mobile device model. The positioning of the transparent window 114B and the light diffuser 116B may match (correspond) to the camera configuration of mobile device 130B and may be specific to a second mobile device model. The first mobile device model may be different from the second mobile device model. As mentioned above, the box structure 102 may include a transparent window 114A protected by a removable cover 108A and / or a transparent window 114B protected by a removable cover 108B. In the embodiment shown in FIG. 1 , a user may choose to remove either the removable cover 108A or 108B depending on the model or set of mobile device models used with the box 100. In some embodiments, each of the windows 114A and 114B may be suitable for several different models of mobile devices with similarly positioned cameras. In such embodiments, tolerances may exist in the size and / or position of the windows 114A, 114B and the diffusers 116A, 116B, so that multiple models of mobile devices may be accommodated. In one example, it may be desirable to remove only the removable cover 108A corresponding to the mobile device 130A to prevent external light from penetrating into the interior of the box structure 102 through the unused removable cover 108B. In another example, it may be desirable to remove only the removable cover 108B corresponding to the mobile device 130B to prevent external light from penetrating into the interior of the box structure 102 through the unused removable cover 108A.The location of the test apparatus alignment mark 124A and adhesive pad 122A on the test carriage to match a mobile device configuration may be specific to a mobile device model or set of mobile device models. The location of the test apparatus alignment mark 124B and adhesive pad 122B on the test carriage to match a mobile device configuration may be specific to a mobile device model or set of mobile device models. Such test apparatus alignment marks 124A and / or 124B may include, for example, an outline indicating where the test apparatus 202 should be placed. The box height h, which matches the ideal focal length of the mobile device camera 128, may be specific to a mobile device model. For some mobile device models, the minimum focal length to produce a focused image may be approximately 15 cm, and in some embodiments, the box height h may be approximately 15 cm or greater. In some embodiments, box 100 may be at least partially foldable or unfoldable between a shipping configuration and an imaging configuration, where in the shipping configuration, box 100 may have a first height suitable for containing test device 202 and any other kit components (e.g., instructions, swabs, etc.), and in the imaging configuration, box 100 may have a second height h that is greater than the first height, where the second height h may correspond to a desired focal length for imaging test device 202. In some embodiments, box 100 may be at least partially foldable or unfoldable between a shipping configuration in which box 100 is folded flat and an imaging configuration in which box 100 has a second height h that is greater than the first height, where the second height h may correspond to a desired focal length for imaging diagnostic test device 202. Box 100 may have adjustable dimensions to accommodate various different models of mobile devices. For example, the box may have heights h1, h2, h3, ..., h. n (Each height h1~h n corresponds to the focal length of a model or set of models of the mobile device).

[0072] The aforementioned parameters may be specific to a particular mobile device model, such as a particular mobile phone model. Thus, in some embodiments, a specific disposable package / light box configuration may correspond to each mobile device model. That is, a unique box configuration may correspond to each mobile device model. In some embodiments, such as those shown in FIGS. 1A-1E, a box configuration may correspond to more than one mobile device model. In such embodiments, the overall footprint of the disposable package / light box may be the same across many models of mobile devices, even though the locations of the mobile device mounting marks 106A, 106B and imaging apertures 118A, 118B may vary. In some embodiments, as shown in FIGS. 1A-1E, multiple mobile device mounting marks 106A, 106B and imaging windows 114A, 114B may be incorporated into a single package. This may allow multiple mobile devices to be supported by a single box configuration.

[0073] [Detection of fluorescent signals from the test device] While box 100 is described primarily in the context of colorimetric and reflectance assay modes, box 100 can also be used to permit signals from other types of assays. In one non-limiting example, box 100 can permit detection of fluorescent signals by incorporating appropriate excitation and emission filters into the diffuser and imaging window. In such an embodiment, diffusers 116A and / or 116B can include excitation filters that can permit the passage of light of a wavelength or range of wavelengths that can excite fluorophores in test device 202. This allows excitation light to be transmitted from mobile device light source 126 through excitation filter-containing diffusers 116A and / or 116B to test device 202. Windows 114A and / or 114B can include emission filters that can permit the passage of light of a wavelength or range of wavelengths emitted by fluorophores in test device 202. This allows light emitted by the fluorophores to be transmitted through windows 114A and / or 114B to mobile device camera 128.

[0074] [Light box for test equipment with built-in light source] In some embodiments, the light box of the present disclosure can include a light source, such as a composite light source configured to project relatively uniform and / or homogeneous light across the top surface of a test device (e.g., but not limited to, a diagnostic assay) and a background area. In some embodiments, the composite light source includes multiple light-emitting diodes (LEDs) or other light emitters. The multiple LEDs can include one or more sets of LEDs. The multiple LEDs can be incorporated into one or more LED strips. The housing (box) can be box-shaped and can incorporate one or more downward-facing and / or downward-sloping LED strips on its interior top surface. The box can include an opening on the top to allow a camera to image a surface underneath the box (e.g., the top surface of a test device). The opening can be sized and shaped to receive a mobile device, such as a mobile device.

[0075] [Outline of a light box with a built-in light source] The uniform, bright illumination that can be provided by an integrated, combined light source can improve the sensitivity of point-of-care assay readouts. Such point-of-care assays can include lateral flow immunoassays and colorimetric assays. In the case of lateral flow immunoassays, bright, uniform light can help increase the contrast between the test line and the background surrounding the test line. Uniform illumination can facilitate accurate analysis and / or segmentation of diagnostic test images by preventing shadows in captured images. Figures 3-5 show an exemplary light box system 300 in which the light source is integrated into a box 302. The box 302 can be used with a variety of test devices, including many types of diagnostic assays.

[0076] In some examples, the kit includes a test device 202 (e.g., but not limited to, a diagnostic assay) and a light box 302 incorporating a light source. In some non-limiting examples, the kit may also include a custom mobile device 306 with installed instructions. The mobile device 306 may include a camera configured to capture images and a processor with memory that stores instructions for processing the images. A user may install the custom mobile device in a fixed position relative to the box before imaging the test device, or the custom mobile device may be pre-installed in a fixed position relative to the box. In some embodiments, the box may include a unique opening to fit a particular mobile device. In the example shown in FIG. 3, the opening in the light box 302 is hidden by the mobile device 306. Meanwhile, in the example shown in FIG. 5, an opening 402 is shown in the light box 302. The opening may be unique to the custom mobile device included in the kit. In some embodiments, the top surface of the box may be recessed and may have a recess sized to fit the custom mobile device. In some embodiments, the opening 402 is provided within the recess. In some embodiments, the custom mobile device may be an original equipment manufacturer ("OEM") smartphone. In some embodiments, the custom mobile device may be preloaded with software for analyzing images (e.g., images captured using the light box) and displaying test results based at least in part on the images. In some embodiments, a custom mobile device with preloaded software may be capable of determining the results of a diagnostic assay (or other test device) based at least in part on images captured using the light box.

[0077] FIG. 3 shows an exemplary box with an opening for a mobile device. The box may include one or more insertion ports 308 for various test devices, including diagnostic assays housed in cassettes. For example, one or more insertion ports 308 may be shaped and sized to accept a test assay cassette, a urinalysis dipstick, and / or a colorimetric blood analysis strip. The insertion port 308 may be sized such that when a test assay cassette is inserted, substantially no light or only minimal light may be transmitted from the exterior of the box to the interior of the box through the insertion port 308. The insertion port 308 may be sized such that when a test device (e.g., a test assay cassette 310, a urinalysis dipstick 312, and / or a colorimetric blood analysis strip) is inserted, a portion of the test device remains outside the box, allowing a user to grasp and / or remove the test device when imaging is complete. The recessed opening 314 may be sized and shaped to accept a mobile device 306. Recessed opening 314 may be positioned to align a mobile device with an opening that may allow the mobile device to image test equipment positioned within box 302. In some embodiments, the box does not include a recessed opening, and the mobile device may be placed on the flat top surface of box 302 that includes opening 402.

[0078] Box 302 may include a power cord 304 and / or may include an internal power source, such as a battery. Power cord 304 may be configured to power multiple light sources, such as one or more sets of LEDs, within box 302. The battery may be configured to power multiple light sources, such as one or more sets of LEDs, within box 302. The battery may be a single-use battery (e.g., non-rechargeable and / or disposable) or a rechargeable battery. In certain embodiments in which the battery is rechargeable, box 302 may include a power cord or port that can be connected to a power outlet to thereby charge the battery. In certain embodiments in which the battery is rechargeable, the battery may be removed from the box for recharging.

[0079] FIGS. 4A and 4B show a light box 302, 414 including an opening 402 that may be compatible with many and / or all mobile devices, including many and / or all mobile phones. In some embodiments, the box 302 may include plastic, such as white nylon or thermoplastic. In some embodiments, the box 302 may include paper and / or cardboard. In some embodiments, such as those shown in FIGS. 4B, 8, 9, 11A-11F, and 15, the exterior surfaces of the box 302, 414 may be rectangular and / or flat. In some embodiments, such as those shown in FIG. 5, a portion of the exterior surface of the box 302 may be curved. In some embodiments, such as those shown in FIGS. 4A and 4C, the exterior surface of the box may be trapezoidal. In such embodiments, the side of the box 302 may include multiple surfaces, such as surfaces 410a, 410b, and 410c. The interior walls of the box 302 may optionally include reflective and / or light-scattering materials. For example, the interior walls of the box 302, 414 may include high-gloss white nylon, thermoplastic, and / or porous polytetrafluoroethylene (PTFE). It may be desirable for the interior surface of the box 302 to have a matte finish to scatter and / or diffuse light reflected from the surface. The box may optionally include a diffuser. The diffuser may ensure uniformity of illumination within the box. The diffuser may include frosted plastic. The light source within the box may provide uniform illumination and may be used in a manner that eliminates the need for factory calibration of the light source. For example, the illumination provided by the light source may be consistent enough that image processing by the mobile device obviates the need for factory calibration of the light source.

[0080] FIG. 4A illustrates an exemplary light box 302 that includes a recess or protrusion capable of holding a diagnostic test kit. In some embodiments, the light box may include a recess or protrusion to assist in positioning and / or holding the diagnostic test kit. A recess 404 may serve as a holder for the diagnostic test kit on the bottom surface 406 of the box 302. In implementations that include an insertion port, the recess and / or protrusion may be aligned with the insertion port. In some embodiments, the recess and / or protrusion may be sized to accept the diagnostic test kit and hold it within the imaging area of ​​the box. In some embodiments, the box may include markings to guide a user in placing the diagnostic test kit within the box. Such markings may include, for example, an outline on the inner bottom surface of the box indicating where the diagnostic test kit should be placed. In some embodiments, such as the embodiment shown in FIG. 4B, the box may be capable of accepting a scan card 416. The scan card 416 may include printed markings. The printed marks may be used during analysis of a test device placed on the scan card and / or during analysis of images of the test device and scan card. The printed marks may include, but are not limited to, printed reference colors, control marks, image area boundaries, and other features. The printed marks may be used to analyze the results of tests performed on the test device and / or the appropriateness of lighting, orientation, and focus conditions associated with images of the test device. The scan card 416 may or may not include carriage functionality. For example, the scan card 416 may or may not include marks and / or adhesive patches for alignment and placement of the test device 202. In some embodiments, the bottom surface 406 (including all or a portion of the recess 404) may be the scan card. Marks may be pre-printed on the inner bottom surface during manufacturing of the box 302. In such an example, the user may be guided (instructed) to place the test device 202 on a test placement guide provided (eg, printed) on the bottom interior surface of the box 302 .The test placement guide may be an alignment mark that identifies where to place the test device on the scan card. In such an example, the carriage may not be implemented.

[0081] 4C illustrates a box 302 including multiple light sources. It will be appreciated that embodiments of a light box according to the present disclosure may include any suitable light source, such as, but not limited to, multiple sets of LEDs. The multiple sets of LEDs may include multiple LED strips. FIG. 4C illustrates the positioning of multiple light sources 412, such as multiple LED strips, within the box 302 in some embodiments. The multiple light sources 412 may be positioned inside and above the walls of the box 302.

[0082] In some embodiments, the box 302 may include a diffuser between the light source and the test apparatus (e.g., the test device). The diffuser may include a translucent or semi-transparent material, such as matte plastic, fiber / paper (e.g., rice paper), plastic with an etched surface, glass with an etched surface, or a lens (e.g., a Fresnel lens, regularly spaced lenses, or randomly spaced lenses, among others). The diffuser may position or secure the light source at an angle relative to the location where the test apparatus is to be placed, e.g., the recess 404. In some embodiments, the box 302 may be used with a mobile device 130, such as a smartphone or tablet as a camera. In some embodiments, an opening 402 at the top of the light box may facilitate using the light box with various mobile devices. In some embodiments, the opening 402 at the top of the light box may be specific to a particular type of mobile device (e.g., a particular model or set of models of a mobile device). In some embodiments, an opening 402 in the top of the light box can accept an adapter, which can be specific to a particular model or models of mobile devices, and can fit within opening 402. In embodiments in which a mobile device is used to image test equipment, box 302 can include mobile device placement marks that indicate to the user where the mobile device should be placed for imaging. Such marks can include, for example, an outline on the exterior of the box indicating where the mobile device should be placed. In some embodiments, the box includes a dedicated camera mounted in a fixed position relative to the box.

[0083] Box 302 may include a component for securing multiple light sources 412 within box 302. The component may be capable of securing light sources 412 at a particular angle so that light can be adequately transmitted to the location of the diagnostic test device during imaging. The component may secure multiple light sources 412 at an angle relative to the vertical. In some embodiments, box 302 may include a component, such as element 408 shown in FIG. 4A, for securing multiple light sources, such as one or more LED strips, in a predetermined position within box 302. The component may secure multiple light sources 412, such as one or more LED strips, at an angle relative to the vertical. In some embodiments, component 408 may function as a diffuser for multiple light sources 412. In such embodiments, component 408 may be translucent or semi-transparent. In such embodiments, component 408 may include a matte plastic. In some alternative embodiments, component 408 may be opaque rather than a diffuser. In such an embodiment, the component 408 may be a bracket capable of securing the plurality of light sources 412 in a manner that only minimally interferes with or does not substantially interfere with the transmission of light from the plurality of light sources.

[0084] FIG. 5 shows a light box 302 with an integrated light source 412 containing multiple sets of LEDs. The sets of LEDs can be angled downward at an angle between 15° and 85° relative to the vertical. In some embodiments, the sets of LEDs can be angled at 45° relative to the vertical, as shown in FIG. 5. FIG. 5 shows three different embodiments in which the sets of LEDs are positioned at different heights due to different box heights. Height H is the height H A , the height H A 0.5 inches greater than height H B , or the height H A 1 inch greater than height H C, . The height H of the box 302 may affect the lighting of the test fixture 202 when positioned within the box 302. The height H of the box 302 may meet and / or exceed the ideal focal length of the mobile device camera 128. The height H may be specific to the model of the mobile device. For some models of mobile devices, the minimum focal length to produce a focused image may be approximately 15 cm, and in some embodiments, the box height H of the box 302 may be approximately 15 cm or greater.

[0085] FIG. 6 plots light intensity measurements across the bottom of a box for three different horizontal distances, 1, 2, and 3, between sets of LEDs positioned around the center of the box's bottom. The x- and y-axes of the plot in FIG. 6 correspond to pixel locations in the acquired image. The sets of LEDs were either 500 lux or 1500 lux, as shown. FIG. 7 shows light intensity measurements for a configuration with four sets of LEDs on each interior wall of the box and a configuration with multiple sets (two sets) of LEDs only on two opposing interior walls of the box. The x- and y-axes of the plot in FIG. 7 also correspond to pixel locations in the acquired image. The light source can be angled, for example, 45°, relative to the vertical. For example, the exemplary light box shown in FIG. 3 can include two sets of LEDs at a 45-degree angle relative to the vertical.

[0086] In some embodiments, the box may include a tray capable of diffusing (i.e., acting as a diffuser) light emitted by multiple light sources (e.g., two or more sets of LEDs), thereby creating diffuse lighting conditions for the test apparatus. The tray may be positioned between the multiple light sources and the test apparatus. The tray may include matte plastic.

[0087] FIGS. 8A and 9-10 illustrate a light box 302 that can include a tray 802 capable of diffusing light. With particular reference to FIG. 8A , in some embodiments, the box can include a 3D-printed and / or thermoformed tray 802 as a diffuser for the light source 412 included in the box 302. As shown in FIG. 8A , when the thermoformed tray 802 is inserted into the box 302, the light source 412 can be covered so that light passes through the thermoformed tray 802 before reaching the test fixture 202. As shown in FIG. 8B , providing light sources on four sides can provide more uniform illumination compared to a light box with light sources on two sides. FIG. 9 illustrates a light box 302 without a thermoformed tray. As shown in FIG. 9 , the light source 412 can be attached to an interior wall of the box 302. FIG. 10 illustrates an exemplary tray 802 that can be inserted into the light box 302. The tray 802 can include a test fixture mounting area 804. The test device 202 may be placed on the test device placement area 804. The scan card 416 may be placed on the test device placement area 804, and the test device 202 may be placed on the scan card 416. The test device placement area 804 may include markings for aligning and / or imaging the test device, as described herein with reference to the bottom surface of the box 302.

[0088] 11A-11F show the tray 802 inserted alone into the box 302. FIG. 11A shows a side view of the tray 802. FIG. 11B shows a bottom view of the tray 802. FIG. 11C shows a bottom view of the tray 802 received within the box 302, with the bottom features of the tray 802 oriented to show them. FIG. 11D shows a side view of the box 302, including the base 1104 and lid 1106. FIG. 11E shows a top view of the tray 802 positioned within the box 302. FIG. 11F shows a top view of the tray 802 positioned within the box 302 and a scan card 416 positioned within the tray 802. The test device 202 can be received on the scan card 416 positioned within the tray 802. The tray 802 can include a transparent or translucent material capable of diffusing light. As shown in FIG. 11F, at least a portion of the tray 802 can be positioned between a plurality of light sources (here, LED strips 1102) and the test fixture 202. The LED strips 1102 can be positioned on and / or attached to the tray 802. The LED strips 1102 can be positioned on and / or attached to the underside of the tray 802. FIGS. 11B and 11C illustrate such attachment of the LED strips 1102 to the tray 802. The LED strips 1102 can be positioned on the tray 802 such that when the tray 802 is positioned within the box 302 as shown in FIGS. 11E and 11F, the LEDs 1102 are positioned near an upper corner of the interior of the box 302.

[0089] In embodiments including both a tray 802 and an insertion port, the tray 802 may include a loading opening to allow a test device to be inserted into the tray 802 from outside the box 302 via the insertion port. When the tray 802 is inserted into the box 302, the loading opening may be aligned with the insertion port. The loading opening may be sized and shaped to allow the test device to pass through while minimizing the passage of non-diffused light through the loading opening. In some examples, the loading opening may be sized and shaped to be approximately the same size as the profile cross-section of the test device, and the clearance around the test device when loaded may be less than or equal to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 mm, or greater than or equal to each of these, or any value within a range defined by any two of the foregoing values.

[0090] 11D shows a side view of the box 302 including a base 1104 and a lid 1106. The lid 1106 may include an imaging opening that allows a mobile device to image the test apparatus 202. The lid 1106 may be removable. The lid 1106 may be removable to facilitate placement of the tray 802 and / or the test apparatus 202.

[0091] In some embodiments where the plurality of light sources 412 includes sets of LEDs, there may be at least 2, at least 4, at least 8, at least 10, at least 16, at least 20, at least 24, and / or at least 30 LEDs in the box. It will be understood that other numbers of LEDs may also be suitably implemented. The sets of LEDs may include LEDs spaced apart from one another by approximately 0.1, 0.2, 0.3, 0.4, 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 cm, or more, or any value within a range defined by any two of the foregoing values, although other spacings may be used in some embodiments. In some embodiments, the LEDs are spaced apart from one another by at least about 1 cm. The total number of LEDs, the spacing between the LEDs, the intensity of the LEDs, and the size and / or shape of the box 302 may all be selected to provide adequate brightness and diffusion of illumination within the box 302 during imaging. The size of the test assay cartridge may also be considered when selecting the total number of LED lights, the intensity of the LED lights, the spacing between the LED lights, and the size of the box. In accordance with the present disclosure, other types of light sources may also be suitably implemented within the light box in addition to or instead of LED light sources.

[0092] Some embodiments include differential illumination provided by multiple, alternating light sources, such as different sets of LEDs. Each light source, e.g., each set of LEDs, can be configured to emit a specific wavelength and / or wavelength range to optimize diagnostic test readings. The emission wavelengths and / or emission wavelength ranges of the multiple light sources can be different. As a non-limiting example, multiple LED lights can be configured to provide white light, while another multiple LED light can be configured to provide light in a narrower frequency range of visible or invisible light. These alternating light sources can be used to enhance the contrast and luminescence of conjugate materials used in next-generation diagnostic assays.

[0093] [Fluorescence image detection] While box 302 is described primarily in the context of colorimetric and reflectance assay modes, box 302 can also be used to permit fluorescence image detection by incorporating appropriate excitation and emission filters. In some such embodiments, diffusion tray 802 can include excitation filters that can permit the passage of light at wavelengths or wavelength ranges that can excite fluorophores in the test device. In some such embodiments, multiple light sources 412 can be capable of emitting light at excitation wavelengths but not emission wavelengths. In either case, excitation light can be transmitted to the test device from multiple light sources. Aperture 402 can include emission filters that can permit the passage of light at wavelengths or wavelength ranges emitted by fluorophores in the test device. This allows light emitted by the fluorophores to pass through the emission filters and be transmitted to the mobile device camera.

[0094] [Sintered Optical Components in Diagnostic Test Hardware] As mentioned above, in various embodiments, it may be desirable to improve the uniformity or homogeneity of illumination light within a light box. Accordingly, aspects of the present disclosure relate to materials such as sintered polymers for inclusion in light boxes according to the present disclosure. In some embodiments, sintered polymers may be used within light boxes of the present disclosure, for example, as a lining, a coating, and / or an interior surface of the light box. Sintered polymers, and more specifically sintered polymer-based reflectors, present another technology platform with many attractive features for use in diagnostic test hardware.

[0095] A Lambertian surface can have a nearly constant reflectivity of light, regardless of the angle of the incident light. Figure 12A illustrates this phenomenon diagrammatically, where the angle of the reflected beam 1206 from a Lambertian reflector 1202 is independent of the angle of the incident light beam 1204. Sintered polytetrafluoroethylene ("PTFE")-based reflectors are exemplary Lambertian reflectors. Some such materials can have a nearly constant reflectivity over a wide wavelength range, e.g., from 250 to 2500 nm, or from ultraviolet (UV) to mid-infrared (MIR). In the 300 to 1500 nm spectral range, such materials can achieve up to 99% reflectivity. In some embodiments, the high reflectivity of sintered PTFE can eliminate the need for a diffuser between the light source and the imaging surface of a light box.

[0096] Sintered PTFE coatings may have several properties that make them useful for coating the interior of the light boxes of the present disclosure. Sintered PTFE polymer reflectors have nearly constant transmittance and absorbance from about 275 nm to about 500 nm, as shown in FIG. 12B. The percentage of reflected light may also be independent of the thickness of the PTFE layer. For a given layer thickness, the reflectance of sintered PTFE polymer does not vary substantially as a function of average pore size over a range of about 2 μm to 6 μm, as plotted in FIG. 13.

[0097] 14A-14C present the results of one imaging experiment to demonstrate the effect of applying sintered PTFE to improve illumination uniformity within a light box in accordance with an embodiment of the present disclosure. FIG. 14A shows a top view of a light box 500 made of brown cardboard. It has dimensions of 315 mm x 180 mm x 125 mm and a 50 mm x 30 mm opening window 510 on the top surface, where a smartphone 520 is placed. The smartphone 520 has an F / 1.7 camera lens, 12.2 megapixels, and a built-in white LED. The focal length set within the light box 500 for smartphone 520 imaging is approximately 120 mm over a field of view of 103 mm x 77 mm.

[0098] The imaging experiment consisted of two phases. During Phase 1, all interior surfaces of the light box 500 were covered with white paper cut from standard A4 printer paper. One image captured by a smartphone with automatic exposure control during LED flash illumination is shown in Figure 14B. Here, a test cartridge 530, measuring approximately 96 mm in length, was centered within the field of view, and a region of interest 540 selected for illumination analysis was also centered. From the illumination analysis, the average illumination profile along the horizontal direction was calculated and plotted below the selected region. As shown in Figure 14B, the illumination profile along the horizontal direction was curved rather than flat, i.e., the illumination within the field of view was relatively non-uniform.

[0099] During Phase 2, all interior surfaces of the light box 500 were covered with sintered PTFE cut from a 0.5 mm sheet (3M 300LSE). One image captured by a smartphone with automatic exposure control during LED flash illumination is shown in Figure 14C. Here, the same test cartridge 530 was centered within the field of view, and a region of interest selected for illumination analysis was also shown at 540. All other imaging conditions were identical. From the illumination analysis, the average illumination profile along the horizontal direction was calculated and plotted below the selected region. As shown in Figure 14C, the sintered PTFE material coating the interior surfaces of the light box 500 not only resulted in more uniform illumination within the field of view, but also increased illumination intensity by approximately 5%.

[0100] To improve imaging of various test devices, PTFE-based sintered reflective materials can be used with various embodiments of the light boxes disclosed herein. For example, PTFE-based sintered reflective materials can be used in at-home tests that use a mobile device, such as a smartphone camera and app, to capture and interpret results, eliminating the human subjectivity present in other visually read at-home diagnostic tests. Porous PTFE (e.g., porous Teflon®) is an exemplary sintered polymer material that can be suitably implemented in light boxes according to the present disclosure. Furthermore, PTFE's resistance to oxidation can ensure it will not yellow or discolor during storage.

[0101] An exemplary test used with a light box containing sintered PTFE is the urinary albumin-to-creatinine ratio (ACR) test. The ACR test uses standard colors printed on the cartridge / image to perform color calibration. Ground truth color information (gtXYZ) for the printed standard colors can be established using a densitometer with a D65 lighting setting. Test images captured under different lighting conditions may exhibit greater bias in test results after the color calibration process. It has also been observed that uneven lighting on the cartridge occurs when shadows or uneven lighting conditions are present. Factors such as uneven lighting, shadows, and glare can affect the color calibration process. Higher variability in albumin and creatinine readings may also be observed under soft light or fluorescent lighting conditions. This situation can lead to an error message for the end user indicating that the captured image is unreadable. This can lead to end-user frustration and inhibit widespread adoption of point-of-care tests such as the ACR test.

[0102] [Overview of sintered optical components used in light boxes] A PTFE-based sintered reflector can be incorporated into a box (e.g., a light box) in accordance with the present disclosure. FIGS. 15A and 15B show the exterior of such a light box. FIG. 15C shows a view through the opening of such a box after an insert or carriage (e.g., but not limited to, a scan card 416) and a test device 202 have been received within the box. The PTFE-based sintered reflective layer can improve the uniformity of light distribution in any type of light box. Light box embodiments with a PTFE-based sintered reflector can include light boxes that include built-in light sources and / or imaging devices in accordance with the present disclosure. Some embodiments can include a light box that is a disposable box that can function as a package in accordance with the present disclosure.

[0103] In some embodiments, at least one interior surface of the box includes a layer of sintered PTFE polymer. In some embodiments, some or all of the interior surfaces of the box, such as the interior bottom, sides, and / or top of the box, include a layer of sintered PTFE polymer. In some embodiments, an insert or cartridge carriage with sintered PTFE polymer may be incorporated with the optical box. In one example, a user removes a scan card 416 from the box 302, positions a test cartridge on the scan card 416, and reinserts the scan card 416 with the test cartridge into the box for analysis. In some embodiments, the box including the sintered PTFE polymer layer may include one or two open ends. The PTFE layer may be a thin layer, film, or the like. Suitable ranges for the thickness of the sintered PTFE layer may be 0.2 mm to 2.0 mm, 0.5 mm to 1.0 mm, and / or less than 0.5 mm, although other ranges or values ​​may also be suitable. In certain embodiments, a suitable range for the thickness of the sintered PTFE layer may be 0.2 mm to 1.0 mm. When a light source (e.g., a flash LED on a mobile device or an internal light source in a light box) is used, uniform and consistent lighting conditions are provided on the carriage's printed reference colors (if printed reference colors are included on the carriage for colorimetric testing) and for cartridge imaging, which can help improve cartridge images obtained during diagnostic testing.

[0104] Light boxes incorporating PTFE-based sintered reflectors according to the present disclosure may advantageously implement packaging configurations with reduced profiles or volumes while maintaining improved light distribution in an assembled configuration for use. In one non-limiting example, a kit includes a light box in the form of a flat-folded box. The light box may include any of the features described herein, including, but not limited to, a window for image capture and alignment marks. The kit may optionally include a test carriage and a test device (e.g., a diagnostic test such as an assay test strip). The test carriage and test device may be packaged within or with the flat-folded box. In one non-limiting example, the kit includes a mobile device configured to image and interpret the diagnostic test. The kit may also include instructions for a user to assemble the flat-folded box from its flat packaging configuration into a three-dimensional assembly configuration by unfolding (popping) the box into a three-sided box, a four-sided box, a five-sided box, or a six-sided box using pre-applied folds. The flat-folded box may include a pre-applied adhesive (sticky adhesive) to secure the box in its three-dimensional assembly configuration. In its flat packaging configuration, the flat-folded box may be very compact for shipping, storage, and display. In its three-dimensional assembly configuration, the flat-folded box may have a height optimized for producing focused images using a wide range of mobile devices, for example, but not limited to, a height of 15 cm. In one non-limiting example, the flat-folded box is converted into a four-sided box that opens on two ends. The interior surface of the box may be coated with a PTFE-based sintered reflector, as described above, which can optimize light distribution within the light box. Some embodiments of the light box can be shipped in a flat form and assembled at the point of use into a box with optimal height and light distribution characteristics, advantageously reducing manufacturing, shipping and storage costs.

[0105] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The use of the term "including," as well as other forms such as "include," "includes," and "included," is not intended to be limiting. The use of the term "having," as well as other forms such as "have," "has," and "had" is not intended to be limiting. Terms such as "comprising," "include," and "have" are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. That is, the foregoing terms should be construed synonymously with the phrases "having at least" or "including at least." For example, when used in the context of a process, the term "comprising" means that the process includes at least the referenced "Comprising" means that the device includes at least the recited features or components, but may also include additional steps. When used in the context of an apparatus, the term "comprising" means that the apparatus includes at least the recited features or components, but may also include additional features or components. Also, the term "or" is used in an inclusive (rather than exclusive) sense; for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Furthermore, as used herein, the term "each" has its ordinary meaning, and can also refer to any subset of the set of elements to which the term "each" applies.

[0106] Conjunctions such as "at least one of X, Y, and Z," unless specifically stated otherwise or understood otherwise within the context, are generally intended to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctions are generally not intended to indicate that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0107] The term "and / or" as used herein has its broadest, non-limiting meaning and means that the disclosure includes A only, B only, both A and B, or alternatively, A or B, but does not require both A and B, or one of A, or one of B. As used herein, the phrase "at least one of" A, B "and" C should be interpreted to mean the logical A or B or C, using a non-exclusive logical OR.

[0108] Conditional language used herein, such as "can," "could," "might," and "may," is generally intended to convey that certain features, elements, and / or steps are optional, unless specifically stated otherwise or understood otherwise within the context. Thus, such conditional language is not generally intended to indicate that the features, elements, and / or steps are required in any manner. Terms such as "comprising," "include," and "have" are used in an inclusive and open-ended manner and do not exclude additional elements, features, actions, operations, etc. Additionally, the term "or" is used in an inclusive (as opposed to exclusive) sense; for example, when used to connect a list of elements, the term "or" may refer to one, some, or all of the elements in the list.

[0109] Any method disclosed herein does not have to be performed in the order described. The methods disclosed herein include specific actions to be performed by a practitioner, but may also include third-party instructions regarding those actions, whether explicit or implicit.

[0110] Some or all of the methods and tasks described herein may be performed by a computer system and may be fully automated. A diagnostic test system according to the present disclosure may, in some cases, comprise a computer system that may include multiple distinct computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions (instructions) or modules stored in memory or other non-transitory computer-readable storage media or devices (e.g., solid-state storage devices, disk drives, etc.). Various functions disclosed herein may be embodied in such program instructions and / or implemented in the computer system's application-specific circuitry (e.g., ASIC or FPGA). When a computer system includes multiple computing devices, these devices may, but need not, be co-located. The results of the methods and tasks of the present disclosure may be persistently stored by converting physical storage devices, such as solid-state memory chips and / or magnetic disks, to a different state. The computer system may be a cloud-based computing system whose processing resources are shared by multiple distinct business entities or other users.

[0111] While the foregoing detailed description illustrates, describes, and points out novel features, it will be understood that various omissions, substitutions, and changes may be made in the form and details of the devices, systems, and methods without departing from the spirit of the disclosure. As will be recognized, certain portions of the description herein may be embodied in a form that does not provide all of the features and advantages described herein, since some features may be used or practiced in isolation from other features. Consequently, the disclosure is not intended to be limited to the particular embodiments disclosed herein, but rather to cover all modifications and alternatives that fall within the true scope and spirit of the disclosure.

Claims

1. 1. A light box for imaging a diagnostic test device, comprising: a box structure configured to package the diagnostic test device prior to use of the diagnostic test device; Equipped with The box structure is: a plurality of side walls and a top surface defining an interior volume; at least one opening in the top surface; It has The at least one opening is configured to allow a mobile device to image the diagnostic test device through the opening while the diagnostic test device is disposed within the interior volume. A light box characterized by:

2. a carriage sized and shaped to fit within the interior volume of the light box and configured to facilitate positioning of the diagnostic test device within the light box for imaging by the mobile device; 10. The light box of claim 1 further comprising:

3. The carriage has an adhesive configured to secure the diagnostic test device to the carriage.

3. The light box of claim 2.

4. The carriage has at least one alignment mark that identifies the mounting position of the diagnostic test device on the carriage.

3. The light box of claim 2.

5. the at least one opening has a transparent window; The mobile device is at least partially placed on the transparent window.

2. The light box of claim 1.

6. The top surface is configured to support the mobile device while the mobile device images the diagnostic test device through the opening.

2. The light box of claim 1.

7. a polytetrafluoroethylene (PTFE) polymer coating on at least one interior surface of said box structure; 10. The light box of claim 1 further comprising:

8. The at least one aperture is sized and shaped to simultaneously accommodate image capture by a camera on the mobile device and illumination of the diagnostic test device by a light emitter on the mobile device.

2. The light box of claim 1.

9. The at least one opening is a first opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model mobile device having a first camera and flash configuration; a second opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model mobile device having a second camera and flash configuration; have 2. The light box of claim 1.

10. The top surface has at least one alignment mark that identifies the placement position of the mobile device on the top surface.

2. The light box of claim 1.

11. a light diffuser positioned above or below the opening 10. The light box of claim 1 further comprising:

12. The light diffuser is attached to the bottom surface of a transparent window that at least partially covers the opening.

12. The light box of claim 11.

13. a removable protective cover covering at least a portion of the opening; 10. The light box of claim 1 further comprising:

14. the light box is configured to be foldable between a shipping configuration and an imaging configuration; the shipping configuration has a first height; the imaging configuration has a second height greater than the first height; The second height corresponds to an imaging focal length of the mobile device.

2. The light box of claim 1.

15. the upper surface is recessed from the top surface of the box structure; The top surface is configured to receive and hold the mobile device.

2. The light box of claim 1.

16. 1. A light box for imaging a diagnostic test device, comprising: a box structure having at least one opening; a plurality of light sources positioned within an interior volume of the box structure; Equipped with The at least one aperture is configured to allow a mobile device to image the diagnostic test device from a predetermined distance. A light box characterized by:

17. The light source includes a plurality of LEDs.

17. The light box of claim 16.

18. The light source comprises one or more LED strips 18. The light box of claim 17.

19. The plurality of LEDs are one or more first LEDs configured to emit a first set of wavelengths; one or more second LEDs configured to emit a second set of wavelengths different from the first set of wavelengths; have 18. The light box of claim 17.

20. The plurality of LEDs are a first plurality of LEDs disposed along a first interior side of the light box; a second plurality of LEDs disposed along a second interior side of the light box opposite the first interior side; have 18. The light box of claim 17.

21. a third plurality of LEDs disposed along a third interior side of the light box; a fourth plurality of LEDs disposed along a fourth interior side of the light box; 20. The light box of claim 17 further comprising:

22. a diffuser configured to diffuse light from the light source into the light box; 17. The light box of claim 16 further comprising:

23. The diffuser includes a tray shaped and sized to receive the diagnostic test device in alignment with the imaging area.

23. The light box of claim 22.

24. The tray comprises a matte plastic 24. The light box of claim 23.

25. The tray comprises thermoformed plastic or 3D printed plastic.

24. The light box of claim 23.

26. The LEDs are positioned so that they face downward at an angle of 15° to 85° relative to the vertical.

18. The light box of claim 17.

27. The LEDs are positioned so as to face downward at an angle of 45° relative to the vertical direction.

27. The light box of claim 26.

28. The spacing between adjacent LEDs among the plurality of LEDs is about 1 cm.

18. The light box of claim 17.

29. the box structure having a plurality of side walls and a top surface defining the interior volume; The at least one opening is in the top surface and is configured to allow the mobile device to image the diagnostic test device through the at least one opening while the diagnostic test device is disposed within the interior volume.

17. The light box of claim 16.

30. The box structure has a base and a lid; The at least one opening is provided in a top surface of the lid.

17. The light box of claim 16.

31. The box structure is configured to receive the diagnostic test device within the base when the lid is removed from the box structure.

31. The light box of claim 30.

32. The box structure is configured to receive the diagnostic test device through an opening in a side wall of the box structure.

17. The light box of claim 16.

33. 1. A light box for imaging a diagnostic test device, comprising: A box structure configured to deploy from a shipping configuration to an imaging configuration for use with said diagnostic test device. Equipped with The box structure is: a plurality of side walls and a top surface defining an interior volume; at least one opening in the top surface; It has The at least one opening is configured to allow a mobile device to image the diagnostic test device through the opening while the diagnostic test device is disposed within the interior volume. A light box characterized by:

34. a carriage sized and shaped to fit within the interior volume of the light box and configured to facilitate positioning of the diagnostic test device within the light box for imaging by the mobile device; 34. The light box of claim 33 further comprising:

35. The carriage has an adhesive configured to secure the diagnostic test device to the carriage.

35. The light box of claim 34.

36. The carriage has at least one alignment mark that identifies the mounting position of the diagnostic test device on the carriage.

35. The light box of claim 34.

37. the at least one opening has a transparent window; The mobile device is at least partially placed on the transparent window.

34. The light box of claim 33.

38. The top surface is configured to support the mobile device while the mobile device images the diagnostic test device through the opening.

34. The light box of claim 33.

39. a polytetrafluoroethylene (PTFE) polymer coating on at least one interior surface of said box structure; 34. The light box of claim 33 further comprising:

40. The at least one aperture is sized and shaped to simultaneously accommodate image capture by a camera on the mobile device and illumination of the diagnostic test device by a light emitter on the mobile device.

34. The light box of claim 33.

41. The at least one opening is a first opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model mobile device having a first camera and flash configuration; a second opening sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model mobile device having a second camera and flash configuration; have 34. The light box of claim 33.

42. The top surface has at least one alignment mark that identifies the placement position of the mobile device on the top surface.

34. The light box of claim 33.

43. a light diffuser positioned above or below the opening 34. The light box of claim 33 further comprising:

44. The light diffuser is attached to the bottom surface of a transparent window that at least partially covers the opening.

44. The light box of claim 43.

45. a removable protective cover covering at least a portion of the opening; 34. The light box of claim 33 further comprising:

46. the shipping configuration has a first height; the imaging configuration has a second height greater than the first height; The second height corresponds to an imaging focal length of the mobile device.

34. The light box of claim 33.

47. the upper surface is recessed from the top surface of the box structure; The top surface is configured to receive and hold the mobile device.

34. The light box of claim 33.

48. The box structure is reusable 48. A light box according to any preceding claim.

49. The box structure is disposable 48. A light box according to any preceding claim.

50. the diagnostic test device disposed within the interior volume 48. A light box according to any preceding claim, further comprising:

51. The light box is the shipping container for the diagnostic test device.

48. A light box according to any preceding claim.

52. 1. A method for imaging a test device, comprising: deploying a light box with an aperture from a shipping configuration to an imaging configuration; placing a test device within the light box in the imaging configuration; imaging the test device using a mobile device; A method comprising:

53. Removing a cover from the opening of the light box.

53. The method of claim 52 further comprising:

54. aligning a camera of the mobile device with the aperture 53. The method of claim 52 further comprising:

55. aligning the test device with the opening 53. The method of claim 52 further comprising:

56. placing the mobile device on a surface of the light box; 53. The method of claim 52 further comprising:

57. The step of placing the test device in the light box comprises: placing the test device on a carriage; inserting the carriage into the light box; 53. The method of claim 52, comprising:

58. Adhering the test device to the carriage.

58. The method of claim 57 further comprising:

59. In the imaging configuration, the light box has a height equal to or greater than the focal length of the mobile device.

53. The method of claim 52.

60. the box structure is reusable; The method comprises: Reusing the light box.

60. The method of any of claims 52 to 59, further comprising:

61. the box structure is disposable; The method comprises: Disposing of the light box.

60. The method of any of claims 52 to 59, further comprising:

62. The diagnostic test device is disposed within the interior volume in the shipping configuration.

60. The method of any one of claims 52 to 59.

63. The light box is the shipping container for the diagnostic test device.

60. The method of any one of claims 52 to 59.

Images