Lamp box system for interrogation of optical measurement piece

Abstract

Aspects of the present disclosure relate to a lamphouse capable of improving imaging of a point-of-care testing device. In one aspect, the disposable lamphouse may also be used as a package for test equipment. In one aspect, a light box includes an integrated light source. In one aspect, a PTFE layer may be applied to an interior surface of the light box to improve light distribution to a top surface of a test device received within the light box.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 379,876, filed on October 17, 2022, and U.S. Provisional Application No. 63 / 519,808, filed on August 15, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to analyte testing, and more particularly to point - of - care diagnostic testing and imaging. Background Art

[0004] Test analysis information can be obtained from images of test devices (such as lateral flow assays or other cartridge - based tests). The determination of analysis information based on image analysis can be susceptible to errors based on color management, alignment, image distortion, and other sources of error within the captured image. For example, such methods can be susceptible to reading errors (such as false - negative results) due to degraded image quality (e.g., high noise levels, poor illumination, poor focus, significant motion blur, etc.) and / or algorithmic errors (e.g., insufficient homography, insufficient normalization, etc.).

[0005] In addition, many optical diagnostic tests (such as tests using colorimetric or reflectance signal interrogation) rely on relatively diffuse and uniform illumination to achieve accurate signal readings. As smartphone cameras have started to be used for reading test devices, indoor ambient light is still responsible for illumination. Analyzing images captured by the cameras of smartphones or other mobile devices can be particularly susceptible to such errors. Summary of the Invention

[0006] To limit the occurrence of errors in image - based test analysis systems, imaging systems for test analysis typically operate in very controlled environments and are carefully calibrated and normalized. Controlling the imaging environment can pose challenges for point - of - care testing because users may not have the equipment required to produce consistent, high - quality images. A light box according to the present disclosure can ensure consistent and reproducible imaging conditions.

[0007] In one non - limiting example, a light box for imaging a diagnostic test device is provided. The light box includes a box structure configured to package the diagnostic test device prior to use, the box structure including: a plurality of sidewalls and an upper surface defining an interior volume; and at least one aperture in the upper surface, the at least one aperture being configured to allow a mobile device to image the diagnostic test device through the aperture when the diagnostic test device is disposed within the interior volume.

[0008] The light box may include a carriage, the size and shape of the carriage being designed to be adapted to fit within the internal volume of the light box, and the carriage being configured to facilitate positioning 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 location for placing the diagnostic test device on the carriage.

[0009] The light box may include at least one aperture including a transparent window, and wherein the mobile device at least partially rests on the transparent window. The upper surface of the light box may be configured to support the mobile device when the mobile device images the diagnostic test device through the aperture. The light box may include a polytetrafluoroethylene (PTFE) polymer coating on at least one inner surface of the box structure. The size and shape of the at least one aperture may be designed to simultaneously accommodate image capture by the camera of the mobile device and illumination of the diagnostic test device by the light emitter of the mobile device. The at least one aperture of the light box may include a first aperture and a second aperture, the size and shape of the first aperture being designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model of mobile device having a first camera and flash configuration, and the size and shape of the second aperture being designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model of mobile device having a second camera and flash configuration. The upper surface of the light box may include at least one alignment mark identifying a location for placing the mobile device on the upper surface. The light box may further include a light diffuser positioned above or below the aperture. The light diffuser may be secured to the bottom surface of a transparent window at least partially covering the aperture. The light box may include a removable protective cover over at least a portion of the aperture. The light box may be configured to be foldable between a transport configuration having a first height and an imaging configuration having a second height greater than the first height, the second height corresponding to the imaging focal length of the mobile device. The upper surface of the light box may be recessed from the top surface of the box structure and be configured to receive and hold the mobile device.

[0010] In another non - limiting example, a method of imaging a test device is provided. The method may include unfolding a light box from a transport configuration to an imaging configuration, wherein the light box includes an aperture; placing a test device within the light box in the imaging configuration; and imaging the test device using a mobile device.

[0011] The method may include removing a lid from the aperture of the light box. The method may include aligning a camera of the mobile device with the aperture. The method may include aligning the test device with the aperture. The method may include placing the mobile device on a surface of the light box. Placing the test device within the light box may include placing the test device on a tray and inserting the tray into the light box. The method may further include adhering the test device to the tray. In the imaging configuration, the light box may have a height greater than or equal to the focal length of the mobile device.

[0012] In another non - limiting example, a light box for imaging a diagnostic test device is provided. The light box may include a box structure that includes at least one aperture configured to allow a mobile device to image the diagnostic test device from a distance; and a plurality of light sources positioned within an interior volume of the box structure.

[0013] The light sources may include a plurality of LEDs. The light sources 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 includes a first plurality of LEDs disposed along a first inner side of the light box and a second plurality of LEDs disposed along a second inner side of the light box opposite the first inner side.

[0014] The light box may further include a third plurality of LEDs disposed along a third inner side of the light box and a fourth plurality of LEDs disposed along a fourth inner side of the light box.

[0015] The light box may include a diffuser configured to diffuse light from the light sources within the light box. The diffuser may include a tray shaped and sized to receive the diagnostic test device at a location aligned with the imaging area. The tray may include frosted plastic. The tray may include thermoformed plastic or 3D - printed plastic.

[0016] The plurality of LEDs may be positioned to face downward at an angle between 15° and 85° relative to the vertical direction. The plurality of LEDs may be positioned to face downward at 45° relative to the vertical direction. The spacing between adjacent LEDs of the plurality of LEDs may be about 1 centimeter. The housing structure may include a plurality of sidewalls and an upper surface that define the interior volume. The at least one aperture may be provided in the upper surface and configured to allow the mobile device to image the diagnostic test device through the at least one aperture when the diagnostic test device is disposed within the interior volume. The housing structure may include a base and a lid, and wherein the at least one aperture is provided within the upper surface of the lid. The housing structure may be configured to receive the diagnostic test device into the base when the lid is removed from the housing structure. The housing structure may be configured to receive the diagnostic test device through an opening in a sidewall of the housing structure.

[0017] In another non - limiting example, a light box for imaging a diagnostic test device is provided. The light box includes: a housing structure configured to deploy from a transport configuration to an imaging configuration for use with the diagnostic test device, the housing structure including: a plurality of sidewalls and an upper surface that define an interior volume; and at least one aperture in the upper surface, the at least one aperture being configured to allow a mobile device to image the diagnostic test device through the aperture when the diagnostic test device is disposed within the interior volume.

[0018] The light box may include a cradle, the size and shape of the cradle being designed to be adapted to fit within the interior volume of the light box, and the cradle being configured to facilitate positioning the diagnostic test device within the light box for imaging by the mobile device. The cradle may include an adhesive configured to secure the diagnostic test device to the cradle. The cradle may include at least one alignment mark that identifies a location for placing the diagnostic test device on the cradle. The at least one aperture may include a transparent window, and the mobile device may rest at least partially on the transparent window. The upper surface of the light box may be configured to support the mobile device when the mobile device images the diagnostic test device through the aperture. The light box may further include a polytetrafluoroethylene (PTFE) polymer coating on at least one inner surface of the box structure. The size and shape of the at least one aperture may be designed to simultaneously accommodate image capture by the camera of the mobile device and illumination of the diagnostic test device by the light emitter of the mobile device. The at least one aperture may include a first aperture and a second aperture, the size and shape of the first aperture being designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model of mobile device having a first camera and flash configuration, and the size and shape of the second aperture being designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model of mobile device having a second camera and flash configuration. The upper surface of the light box may include at least one alignment mark that identifies a location for placing the mobile device on the upper surface. The light box may include a light diffuser positioned above or below the aperture. The light diffuser is fixed to the bottom surface of a transparent window that at least partially covers the aperture. The light box may further include a removable protective cover over at least a portion of the aperture. The transport configuration may include a first height, and the imaging configuration has a second height greater than the first height, the second height corresponding to the imaging focal length of the mobile device. The upper surface of the light box may be recessed from the top surface of the box structure and is configured to receive and hold the mobile device.

[0019] In any non-limiting example, the box structure may be reusable.

[0020] In any non-limiting example, the box structure may be disposable.

[0021] In any non-limiting example, the diagnostic test device may be disposed within the interior volume of the light box.

[0022] In any non-limiting example, the light box may be a transport container for the diagnostic test device. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The features, aspects, and advantages of the embodiments of the present disclosure will now be described in connection with various embodiments with reference to the accompanying drawings. The illustrated embodiments are merely examples and are not intended to be limiting.

[0024] Figures 1A to 1B An example disposable light box according to the present disclosure is shown, which includes two windows for interfacing with different models of mobile devices.

[0025] Figure 1C Shows Figures 1A to 1B a removable tray of the example disposable light box shown in

[0026] Figures 1D to 1E An exemplary mobile device that can be used with the disposable light box is shown.

[0027] Figure 2 An example disposable light box and a mobile device positioned to image a test cartridge are shown.

[0028] Figure 3 A perspective view of an example light box with an integrated light source and a mobile device positioned to image a test cartridge is shown.

[0029] Figure 4A A cross-sectional view of an example light box including a tray for positioning a light source is shown.

[0030] Figure 4B A top view of an example light box is shown.

[0031] Figure 4C A view of an example light box indicating the positioning of a light source within the light box is shown.

[0032] Figure 5 An example light box with an integrated light source is shown.

[0033] Figure 6 The light intensity along the bottom surface of an example light box is plotted for three different distances between light source bars and at two light source intensities.

[0034] Figure 7 The light intensity along the bottom surface of an example light box is plotted for a 2-edge light source configuration and for a 4-edge light source configuration.

[0035] Figure 8A An example light box having a diffuser tray is shown.

[0036] Figure 8B The light intensity along the bottom surface of an example light box having a diffuser tray is plotted for a 2-edge light source configuration and for a 4-edge light source configuration.

[0037] Figure 9 Shows an example light box with a 4-edge light source configuration.

[0038] Figure 10 Shows an example diffuser tray.

[0039] Figures 11A - 11F Shows an example diffuser tray and light sources attached outside and inside the light box.

[0040] Figure 12A Schematically shows the Lambert reflectance.

[0041] Figure 12B Plots the transmittance, absorbance, and reflectance of sintered polytetrafluoroethylene (PTFE) over the optical wavelength range of 250 nm to 500 nm.

[0042] Figure 13 Plots the percentage reflectance of sintered PTFE as a function of median pore size.

[0043] Figure 14A Shows a top view of an example light box with a window interface-connected to a smartphone, which is positioned to image a test cassette in the light box and illuminated by the built-in flash LED of the smartphone.

[0044] Figure 14B Shows in Figure 14A An image of a test cassette taken in an example light box having an inner surface covered with white paper, and a plot showing the illumination profile along the major axis of a rectangle depicted below the image.

[0045] Figure 14C Shows in Figure 14A An image of a test cassette taken in an example light box having an inner surface covered with sintered PTFE, and a plot showing the illumination profile along the major axis of a rectangle depicted below the image.

[0046] Figures 15A to 15C Shows a view of an example light box including a sintered PTFE layer on the inner surface. Detailed Description

[0047] Embodiments of the present disclosure relate to systems and techniques for detecting an analyte of interest that may be present in a biological or non-biological sample such as a fluid. The analyte of interest may include any detectable substance, such as but not limited to antibodies, proteins, haptens, nucleic acids, amplicons, hormones, and hazardous or non-hazardous drugs or contaminants, such as anti-tumor drugs for treating cancer. Throughout the present disclosure, example systems, devices, and methods will be described with reference to the collection, testing, and detection of analytes (such as those related to diagnostic tests for infectious diseases), but it should be understood that the present technology can be used for the collection, testing, and detection of any particle, molecule, or analyte of interest. Test strips, cartridges, and / or devices as 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 and / or their components or operations such as the BD Veritor System for rapid detection of SARS CoV-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, the BD Veritor System, and the BD Veritor Plus System.

[0048] A light box can ensure consistent and reproducible imaging conditions. Ensuring the consistency of imaging conditions may be required for imaging point-of-care test strips, test cartridges, and / or devices. As mobile devices such as mobile phones increasingly include high-quality cameras, such mobile devices can be used for imaging point-of-care assay pieces. A light box that can be used with a mobile device to improve assay piece imaging is disclosed herein. A light box that can be transported with test strips, test cartridges, and / or devices is also disclosed herein. A light box that can be disposed of after one or several uses is also disclosed herein. A light box including an integrated light source that can be used with a mobile device is also disclosed herein. A light box including components for diffusing the light emitted by these light sources that can be used with a mobile device is also disclosed herein. In addition, a sintered PTFE coating is disclosed, which can generally be used in light boxes but can be particularly applicable to any light box disclosed herein, such as to help create diffused illumination conditions for imaging.

[0049] It may be desirable to use the integrated camera of a mobile device (such as a smartphone) as a reader for an optical diagnostic test assay piece because such cameras are generally available and produce increasingly high-quality images. Many methods rely on the user manually aligning the mobile device camera (e.g., by holding the mobile device above the test device) and the test device in the lateral and axial directions to capture the correct region of interest at the correct focal length. However, in this method, the ambient lighting may be poorly controlled and may interfere with the acquisition of the light signal from the test device.

[0050] Illumination using ambient light is highly variable in intensity and spectral profile and does not prevent shadows or illumination artifacts. To improve the usability of a mobile device, such as a smartphone, an on-board light source of the mobile device, such as a flash LED, can be used to provide a consistent and controllable illumination source. However, in some embodiments, it may be desirable to diffuse the light from the source to illuminate a test device without shadows, glare, illumination artifacts, or other conditions that may result in poor imaging. The incorporation of a low-profile light diffuser integrated into a light box can allow an interface-connected mobile device to act as both a light source and an image acquisition module.

[0051] Certain existing devices clip onto a smartphone, covering the camera and flash, to enhance the smartphone's ability to read a test device, which may include a diagnostic assay. However, these devices are limited in their compatibility with smartphone models and may only fit certain shapes and sizes of smartphones. Additionally, certain existing devices use a single-point light source. Such devices may require factory calibration. Certain existing devices do not include a diffuser for evenly distributing light. The single-point light source and the lack of a diffuser may result in an illumination environment with strong illumination gradients, which is not suitable for imaging a test device.

[0052] Furthermore, proper spatial alignment of the test device with the camera is desirable to ensure that the area of interest is captured and to maintain an appropriate focal length between the camera and the test device.

[0053] The device according to the present disclosure can reduce alignment difficulties, standardize illumination conditions, and minimize shadow effects. The disposable light box disclosed herein can incorporate alignment marks, a test device holder, and appropriate sizing into a low-cost light box that can also be used as product packaging. Thus, costs are reduced, and the need for companion accessories is reduced or eliminated.

[0054] Light box

[0055] In one aspect, the present disclosure relates to a box that physically interface-connects a mobile device, such as a smartphone, tablet, or other mobile device capable of capturing images, to a point-of-care assay for signal interrogation and image capture, as Figures 1A - 1C and Figure 2 shown. Figures 1A to 1B A light box 100 is shown. Figure 1C A view of a carriage that can be inserted into the light box 100 is shown. Figures 1D to 1EDepicts an example mobile device that can be used with the light box 100. The light box 100 includes a box structure 102, a surface 104, mobile device placement markers 106A and 106B, removable lids 108A and 108B, pull tabs 110A and 110B, a panel 112, windows 114A and 114B, diffusers 116A and 116B, and apertures 118A and 118B. The light box may also include a test cartridge holder 120. The test cartridge holder 120 may include adhesive pads 122A and 122B. Figure 1A Shows the light box 100 in an initial configuration where the removable lids 108A and 108B have not been removed, and Figure 1B Shows the light box 100 in a configuration where the removable lids 108A, 108B have been removed to expose the apertures 118A and 118B with windows 114A, 114B and diffusers 116A, 116B.

[0056] The light box 100 may include a light diffuser 116A that can disperse and / or diffuse the concentrated illumination from a mobile device light source 126 (such as a flash LED) of the mobile device 130A. The light box 100 may include an aperture 118A that includes a transparent window 114A to enable image capture. The light box 100 may include a light diffuser 116B that can disperse and / or diffuse the concentrated illumination from a mobile device light source 126 (such as a flash LED) of the mobile device 130B. The light box 100 may include an aperture 118B that includes a transparent window 114B to enable image capture. The transparent window 114A may be protected by the removable lid 108A of the box 100. The transparent window 114B may be protected by the removable lid 108B of the box 100. The removable lid 108A may include a pull tab 110A. The removable lid 108B may include a pull tab 110B. Mobile device placement markers 106A and 106B may be provided on the upper surface 104 to allow a user to correctly position a specific model of the mobile device 130A or 130B, thereby ensuring alignment of the (one or more) mobile device cameras 128 and light sources 126 with the integrated transparent window 114A or 114B and the light diffuser 116A or 116B. The mobile device placement marker 106A, the removable lid 108A, the pull tab 110A, the window 114A, the diffuser 116A, and the aperture 118A may be used with the mobile device 130A. The mobile device placement marker 106B, the removable lid 108B, the pull tab 110B, the window 114B, the diffuser 116B, and the aperture 118B may be used with the mobile device 130B.

[0057] A removable test cartridge carrier 120 may be included within the case 100. The carrier 120 may be removed or inserted through a panel 112, which may be opened or closed. The test cartridge carrier 120 may include test device alignment marks 124A and 124B for correctly positioning a test cartridge on the carrier 120 according to a specific model of a mobile device. Adhesive strips 122A and 122B on the carrier may be further provided to fix a test strip, a test cartridge, and / or a test device relative to the carrier 120. The adhesive pad 122A and the test device alignment mark 124A are for use with the mobile device 130A. The adhesive pad 122B and the test device alignment mark 124B are for use with the mobile device 130B.

[0058] Lamp box overview

[0059] In some embodiments, the lamp box 100 may be a disposable lamp box. In some embodiments, the lamp box 100 may serve both as a product package for a test device and as a structure of a low-cost lamp box. In some embodiments, the lamp box 100 may serve both as a shipping container for a test device and as a structure of a low-cost lamp box. The case 100 may be disposable and / or may be reusable for analysis of multiple tests. In some embodiments, the case 100 may be a flat foldable case that a user may fold into an assembled configuration (also referred to herein as an "imaging configuration"). In such an embodiment, the flat foldable case may be packaged with a test device in a shipping box and / or a shipping container. When in the assembled configuration, the case 100 may support the weight of the mobile device 130A and / or 130B placed on the upper surface 104 of the case 100. The case 100 may include adhesive strips to allow the user to fix the case 100 in the assembled configuration. In some embodiments, when assembled, the adhesive strips may be positioned by and / or positioned at the corners and / or edges of the case 100.

[0060] When the test device 202 is positioned on the test cassette carrier 120 and the test cassette carrier 120 is inserted into the light box 100, the apertures 118A and / or 118B and the transparent windows 114A and / or 114B of the box 100 may allow the mobile device camera 128 to record an image of the test device 202. The apertures 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 an image to be captured by the camera 128 and the test device to be illuminated by the light source 126 simultaneously. When positioned on the upper 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"). The mobile device 130 (e.g., a smart phone) may provide a light source 126 (such as a flash LED or other light source of the mobile device 130) to interrogate the test device, which may be an optical assay, such as but not limited to a lateral flow assay, a colorimetric assay, and / or a reflectance-based assay. To provide uniform illumination of the test device, the light emitted from the light source 126 (e.g., a flash LED) of the mobile device 130 may be diffused by incorporating integrated "low profile" light diffusers 116A, 116B, thereby spreading the light over the test device.

[0061] The diffusers 116A, 116B may be attached to, fixed to, and / or embedded within the respective transparent windows 114A, 114B. In some embodiments, the diffusers 116A, 116B may be cast as a single piece within the respective windows 114A, 114B, and the single piece may include a plastic material. As a non-limiting example, the windows 114A, 114B may be cast from a transparent plastic and include a Fresnel lens cast from the plastic to serve as the respective diffusers 116A, 116B. The diffuser 116A and / or 116B may have a surface area of about 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 greater, or any value or range defined by any of the foregoing values. In some embodiments, the diffuser 116A and / or 116B may have a surface area of about 0.5 cm 2 to about 1 cm 2The surface area, although in some embodiments, the diffuser may have a surface area outside of this range. The area of diffuser 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 source 126. The shape of diffuser 116A and / or 116B may be rectangular, circular, or oval. In some embodiments, windows 114A, 114B may include a plurality of respective diffusers 116A, 116B. For example, in the case where the cassette 100 may be used with a mobile device 130A having two or more light sources 126, window 114A may include two or more diffusers 116A, and each of the two or more diffusers 116A corresponds to one of the light sources 126.

[0062] In some embodiments, the positions of windows 114A, 114B and diffusers 116A, 116B on the cassette 100 may be specific to the model of the mobile device, e.g., specific to the mobile device and / or specific to a group of models of mobile devices having a similar camera and / or light source configuration. For example, window 114A and diffuser 116A may be specific to mobile device 130A, while window 114B and diffuser 116 may be specific to mobile device 130B. Although Figures 1A to 1B Two windows 114A and 114B are depicted, but the cassette may include 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more windows. Each window may include one or more diffusers. It will also be understood that in some non-limiting embodiments, window 114 does not include diffuser 116.

[0063] The mobile device placement marks 106A and 106B on the upper surface 104 of the cassette 100 may indicate to the user to align the mobile devices 130A, 130B with the light box 100 such that the cameras 128 of the mobile devices are aligned with the respective transparent windows 114A, 114B. The mobile device placement marks 106A and 106B on the upper surface 104 of the cassette 100 may indicate to the user to align the mobile device with the light box 100 such that the light sources 126 of the mobile device are aligned with the respective diffusers 116A, 116B. Such mobile device placement marks 106A, 106B may include, for example, outlines indicating the positions where the mobile devices 130A, 130B should be placed. In some embodiments, the upper surface 104 may be recessed from the top surface of the cassette 100. The top surface may be positioned further away from the test device 202 than the upper surface 104. The recessing of the upper surface 104 from the top surface may assist the user in positioning the mobile device 130. In some embodiments, the top surface may be formed by a material layer located above and attached to the upper surface 104. In such embodiments, the top surface may include a cutout area that defines the recess between the top surface and the upper surface 104.

[0064] The window 114A and the diffuser 116A can be covered and / or overlaid by the perforated and removable lid 108A of the box 100, which can incorporate a pull tab 110A for easy identification and removal. The window 114B and the diffuser 116B can be covered and / or overlaid by the perforated and removable lid 108B of the box 100, which can incorporate a pull tab 110B for easy identification and removal. The user can remove the removable lid 108 from the box 100 by tearing along the perforated edge of the removable lids 108A, 108B. The pull tabs 110A, 110B can be folded upwards to provide a gripping surface for the user when attempting to remove the removable lids 108A, 108B respectively. The perforated and removable lid 108A of the box 100 can be used to protect the window 114A and / or the diffuser 116A before imaging the test device. The perforated and removable lid 108B of the box 100 can be used to protect the window 114B and / or the diffuser 116B before imaging the test device. The perforated and removable lid 108A of the box 100 can be used to protect the window 114A and the diffuser 116A during the transportation of the box 100 and / or the test device 202. The perforated and removable lid 108B of the box 100 can be used to protect the window 114B and the diffuser 116B during the transportation of the box 100 and / or the test device 202.

[0065] Continuing to refer Figures 1A - 2 , for use with a mobile device light source 126 (such as a flash LED), it may be necessary to include a low-profile light diffuser 116A and / or 116B. As discussed herein, the diffuser 116A and / or 116B can be capable of spreading light over the test device 202, thereby preventing glare in the image captured by the camera 128 and / or uneven distribution of light on the test device 202. Many different materials can be suitable for inclusion in the diffuser 116A and / or 116B, such as fiber / paper or plastic, especially low-cost plastic. In some embodiments, the diffuser 116A and / or 116B can include lenses, such as Fresnel lenses, regularly spaced lenses, or randomly spaced lenses. In some embodiments, the diffuser 116A and / or 116B can include one or more etched surfaces. For example, the diffuser 116A and / or 116B can include etched plastic or etched glass. The lenses and / or the etched surfaces can all be implemented with low-cost and thin plastic, depending on the degree of diffusion and light transmission desired within the box structure 102 and the particular light source 126. In some embodiments, fiber-based (such as rice paper) can be included in the diffuser 116A and / or 116B.

[0066] As Figure 2As shown, to ensure sufficient focal length between the camera 128 of the mobile device and the inner surface of the bottom of the cassette structure 102, where the test device 202 is to be placed on the test cassette carrier 120, the height h of the cassette structure 102 can be matched to a specific mobile device model or a general distance that allows the camera of one or more models of mobile devices to focus on the test device 202. Additionally, when using the window 114 and the alignment marks 124A, 124B ( Figure 1E ), the height h in combination with the positions of the window 114 and the diffuser 116 relative to the test device alignment marks 124A, 124B can ensure that the test device 202 is within the area of the camera field 206 and the diffused light 208. To reliably image the correct area of the test device 202, the test cassette carrier 120 (also referred to herein as the "carrier") is included within the cassette 100.

[0067] As Figure 1E shown, the test cassette carrier 120 can indicate to the user the correct placement of the test device 202 via the test device alignment marks 124A and 124B specific to the mobile device model. The test cassette carrier 120 can be removed from the cassette 100, thereby allowing 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 the adhesive pads 122A or 122B respectively. In some embodiments, the carrier 120 can substantially secure the test device 202 by positioning the test device on the adhesive pads 122A or 122B included on the test cassette carrier 120. As an illustrative example, the adhesive pads 122A and / or 122B can include double-sided adhesive strips. When the test cassette carrier 120 is inserted back into the cassette structure 102, or in the case where the cassette 100 is moved while the test device 202 and the carrier 120 are within the cassette structure 102, the adhesive pads 122A and / or 122B can prevent or inhibit movement of the test device 202 relative to the test cassette carrier 120.

[0068] In addition to the alignment marks described herein, the carrier 120 may also include printed marks. The carrier 120 may or may not include features of the scan card. The carrier 120 may be a scan card with printed marks. The printed marks may be used during the analysis of the test device placed on the scan card and / or the image of the test device and the scan card. The printed marks may include, but are not limited to, printed reference colors, control marks, boundaries of image regions, fiducials, and other features. The printed marks may be used to analyze the results of the tests performed on the test device and / or the adequacy of the illumination, orientation, and focusing conditions associated with the image of the test device. The following applications discuss non-limiting examples of scan cards that may be implemented in accordance with the present disclosure: U.S. Application No. 17 / 098,236, entitled "DIAGNOSTIC TEST KITS FOR SAMPLE PREPARATION AND ANALYSIS", U.S. Application No. 17 / 222,819, entitled "DIAGNOSTIC TEST KITS AND METHODS OF ANALYZING THE SAME", U.S. Application No. 29 / 812,505, entitled "SCAN CARD FOR IN VITRO ASSAY", and U.S. Application No. 29 / 816,279, entitled "SCAN CARD FOR IN VITRO ASSAY", each of which is incorporated herein by reference in its entirety.

[0069] The overall alignment between the windows 114A and / or 114B and the test device 202 may be partially defined by the size of the carrier 120 relative to the housing 100. The size of the carrier 120 may be designed to fit within the housing 100, and the tightness of the fit defines the stacking tolerance between the test device 202 and the mobile device 130. The tighter the fit, the smaller the gap 204 between the carrier 120 and the inner side of the housing structure 102. A loose fit between the carrier 120 and the housing structure 102 (e.g., where the gap 204 is relatively large) may result in the carrier 120 being less precisely aligned within the housing within acceptable tolerances. The removal and insertion of the carrier 120 may be made easier by the loose fit between the carrier 120 and the housing structure 102.

[0070] Optical component alignment can be maintained at least in part by the dimensions and stiffness of the housing 100 and by including fiducial marks on the test device 202 and / or the carriage 120. In other words, the alignment of the camera 128 and the LED light source 126, the diffusers 116A and / or 116B of the mobile device, and the test device 202 can be maintained at least in part by the dimensions and stiffness of the housing 100 and by using fiducial marks on the test device 202. The carriage 120 can also assist in maintaining alignment.

[0071] In some embodiments, the housing structure 102 and / or the carriage 120 include cardboard, which is a material with a low cost and a high strength-to-weight ratio commonly used in consumer packaging. In some embodiments, if relatively high strength is required, the cardboard can be corrugated. In some embodiments, the cardboard can be non-corrugated.

[0072] The inner surface of the housing structure 102 can be coated with or include materials to improve and / or optimize light conditions, such as reflected light brightness and / or illumination homogeneity. Surface reflectivity and color can be the main variables to consider. For example, a reflective coating can maximize the internal ambient brightness. As another example, a matte coating can optimize the internal homogeneity of illumination. Referring below to FIG. 12- Figure 15C The sintered PTFE discussed is an example material that can help increase or maximize the internal homogeneity of illumination and produce a high level of internal ambient brightness when included in the housing structure 102.

[0073] In some examples, the kit includes a test device 202 (which can include a diagnostic assay piece) and a light box 100. The kit can also include instructions for use, including instructions for using the test device 202 and / or instructions for using the light box 100 in conjunction with the test device 202 and the mobile device to produce a suitable image.

[0074] Adapt the light box to different models of mobile devices

[0075] Certain properties of the case 100 can be specific to each model of the mobile device 130. For example, specific dimensions and / or configurations of the case can correspond to one or more different mobile device models, such as the mobile device 130A or the mobile device 130B. The total length and width of the case structure 102 for supporting the mobile device 130A and / or 130B can be specific to the mobile device model. The positioning of the transparent window 114A and the light diffuser 116A can match the camera configuration of the mobile device and can be specific to the first mobile device model. The positioning of the transparent window 114B and the light diffuser 116B can match the camera configuration of the mobile device 130B and can be specific to the second mobile device model. The first mobile device model can be different from the second mobile device model. As described above, the case structure 102 can include the transparent window 114A protected by the removable lid 108A and / or the transparent window 114B protected by the removable lid 108B. In the embodiment depicted in FIG. 1, the user can select to remove the removable lid 108A or 108B according to the model of the mobile device to be used with the case 100 or a group of models of the mobile device. In some embodiments, each of the windows 114A and 114B can be suitably used for several different models of mobile devices with similarly positioned cameras. In such embodiments, there may be tolerances in the size and / or positioning of the windows 114A, 114B and the diffusers 116A, 116B such that more than one model of mobile device can be accommodated. In one example, it may be desirable to only remove the removable lid 108A corresponding to the mobile device 130A to prevent external light from being transmitted into the interior of the case structure 102 via the unused removable lid 108B. In another example, it may be desirable to only remove the removable lid 108B corresponding to the mobile device 130B to prevent external light from being transmitted into the interior of the case structure 102 via the unused removable lid 108A. The positions of the test device alignment marks 124A and the adhesive pads 122A on the test carriage for matching the mobile device configuration can be specific to the mobile device model or a group of mobile device models. The positions of the test device alignment marks 124B and the adhesive pads 122B on the test carriage for matching the mobile device configuration can be specific to the mobile device model or a group of mobile device models. Such test device alignment marks 124A and / or 124B can include, for example, outlines indicating the positions where the test device 202 should be placed. The case height h that matches the ideal focal length of the mobile device camera 128 can be specific to the mobile device model. For several models of mobile devices, the minimum focal length for generating a focused image can be about 15 cm, so in some embodiments, the case height h can be about 15 cm or greater.In some embodiments, the cassette 100 may be at least partially collapsible or non - collapsible between a transport configuration and an imaging configuration. In the transport configuration, the cassette 100 has a first height adapted to enclose the test device 202 and any other kit components (such as instructions, swabs, etc.). In the imaging configuration, the cassette 100 has a second height h greater than the first height, where the second height h corresponds to the desired focal length for imaging the test device 202. In some embodiments, the cassette 100 may be at least partially collapsible or non - collapsible between a transport configuration and an imaging configuration. In the transport configuration, the cassette 100 is folded flat. In the imaging configuration, the cassette 100 has a second height h greater than the first height, where the second height h corresponds to the desired focal length for imaging the diagnostic test device 202. The cassette 100 may have adjustable dimensions to accommodate various different models of mobile devices. For example, the cassette may have a height h. 1 , h 2 , h 3 ,...h n , each height h 1 to h n corresponds to the focal length of one model or several groups of models of mobile devices.

[0076] The above parameters may be unique for a particular model of mobile device (e.g., a particular model of phone). Thus, in some embodiments, a particular disposable packaging / light box configuration may correspond to each mobile device model. That is, the unique cassette configuration uniquely corresponds to each mobile device model. In some embodiments, such as the embodiment depicted in Figures 1A - 1E , the cassette configuration may correspond to two or more mobile device models. In such embodiments, the total footprint of the disposable packaging / light box may be the same for many models of mobile devices, where the positions of the mobile device placement markers 106A, 106B and the imaging apertures 118A, 118B are changed. In some embodiments, multiple mobile device placement markers 106A, 106B and imaging windows 114A, 114B may be incorporated into a single package, as shown in Figures 1A - 1E . This may allow a single - box configuration to support more than one mobile device.

[0077] Detecting the fluorescence signal from the test device

[0078] Although the cassette 100 has been described primarily in the context of colorimetric and reflectance assay modes, the cassette 100 can be used to permit signals from other types of assay devices. In one non-limiting example, the cassette 100 can permit the detection of fluorescence signals by incorporating the correct excitation and emission filters into the diffuser and imaging window. In such an embodiment, diffuser 116A and / or 116B can include an excitation filter that can permit light of a wavelength or wavelength range that can excite the fluorophore of test device 202 to pass therethrough. The excitation light can thus be transmitted from mobile device light source 126 through diffuser 116A and / or 116B, which includes the excitation filter, to test device 202. Window 114A and / or 114B can include an emission filter that can permit light of a wavelength or wavelength range emitted by the fluorophore of test device 202 to pass therethrough. Thus, light emitted by the fluorophore can be transmitted through window 114A and / or 114B to mobile device camera 128.

[0079] Light box with integrated light source for testing equipment

[0080] In some embodiments, the light box of the present disclosure can include a light source, such as, for example, a composite light source in a configuration that projects relatively uniform and / or homogeneous light over the top surface and background region of a test device (such as, but not limited to, a diagnostic assay device). In some embodiments, the composite light source includes a plurality of light emitting diodes (LEDs) or other light emitters. The plurality of LEDs can include one or more sets of LEDs. The plurality of LEDs can be included in one or more LED strips. The housing can be a box with one or more downward-facing and / or downwardly inclined LED light strips included on the interior top surface of the box. The box can include apertures at the top to permit the camera to image the surface of the bottom of the box (such as the top surface of the test device). The size and shape of the apertures can be designed to receive a mobile device, such as a mobile device.

[0081] Overview of a Light Box with an Integrated Light Source

[0082] Homogeneous and bright illumination (such as can be provided by an integrated composite light source) can improve the sensitivity of point-of-care assay readings. Such point-of-care assay devices can include lateral flow immunoassay devices or colorimetric assay devices. For lateral flow immunoassay devices, bright and uniform light can help increase the contrast between the test line and the background portion around the test line. Uniform illumination can also facilitate the precise analysis and / or segmentation of diagnostic test images by preventing shadows in the captured images. Figures 3 - 5 An example light box system 300 is shown with a light source included in cassette 302. Cassette 302 can be used with a range of test devices, including many types of diagnostic assay devices.

[0083] In some examples, the kit includes a test device 202 (such as but not limited to a diagnostic assay device) and a light box 302 with an included light. In some non-limiting examples, the kit may further include a customized mobile device 306 with an instruction manual installed thereon. The mobile device 306 may include a camera configured to capture images and a processor including a memory storing instructions for processing the images. The user may install the customized mobile device at a fixed position relative to the box before imaging the test device, or the customized mobile device may be pre-installed at a fixed position relative to the box. In some embodiments, the box may include apertures specific to a suitable mobile device. In Figure 3 the example shown, the aperture in the light box 302 is blocked by the mobile device 306, while in Figure 5 the example shown in, an aperture 402 is shown in the light box 402. The aperture may be specific to the customized mobile device included in the kit. In some embodiments, the upper surface of the box may be recessed to create a recess sized to fit the customized mobile device. In some embodiments, the aperture 402 is disposed within the recess. In some embodiments, the customized mobile device may be an original equipment manufacturer (“OEM”) smartphone. In some embodiments, the customized mobile device may be pre-loaded with software for analyzing images (such as images captured using the light box) and displaying test results at least in part based on the image. In some embodiments, a customized mobile device with pre-loaded software may be capable of determining the result of a diagnostic assay device (or other test device) at least in part based on an image captured using the light box.

[0084] Figure 3Shows an example cassette including apertures for a mobile device. The cassette may include one or more insertion ports 308 for various test devices, including diagnostic assay elements housed in a cartridge. For example, the shape and size of the one or more insertion ports 308 may be designed to receive a test assay cartridge, a urine analysis ruler, and / or a colorimetric blood analysis strip. The size of the (one or more) insertion ports 308 may be designed such that when a test assay cartridge is inserted, substantially no light or a minimum amount of light from outside the cassette can be transmitted through the (one or more) insertion ports 308 into the interior of the cassette. The size of the (one or more) insertion ports 308 may be designed such that when a test device (e.g., a test assay cartridge 310, a urine analysis ruler 312, and / or a colorimetric blood analysis strip) is inserted, a portion of the test device remains outside the cassette, allowing the user to grasp and / or remove the test device at the end of imaging. The size and shape of the recessed notch 314 may be designed to receive the mobile device 306. The recessed notch 314 may be positioned to align the mobile device with an aperture that may allow the mobile device to image a test device positioned within the cassette 302. In some embodiments, the cassette does not include a recessed notch, and the mobile device may be placed on a flat top surface of the cassette 302 that includes an aperture 402.

[0085] The cassette 302 may include a power cord 304 and / or may include an internal power source such as a battery. The power cord 304 may be configured to power a plurality of light sources (e.g., one or more groups of LEDs) within the cassette 302. The battery may be configured to power a plurality of light sources (e.g., one or more groups of LEDs) within the cassette. The battery may be a single-use battery (e.g., non-rechargeable and / or disposable) or a rechargeable battery. In certain embodiments where the battery is rechargeable, the cassette 302 may include a power cord or port capable of connecting to a power outlet to charge the battery. In certain embodiments where the battery is rechargeable, the battery may be removed from the cassette for recharging.

[0086] Figures 4A to 4B Shows light boxes 302 and 414 including apertures 402 that may be compatible with many and / or all mobile devices, including many and / or all mobile phones. In some embodiments, the cassette 302 may include plastic, such as white nylon, thermoplastic resin. In some embodiments, the cassette 302 may include paper and / or cardboard. In some embodiments, such as Figure 4B Figure 8, Figure 9 and Figures 11A - 11F and the embodiments depicted in Figure 15, the outer surface of the cassette 302 or 414 may be rectangular and / or flat. In some embodiments, such as Figure 5 the embodiments depicted inFigure 4A and Figure 4C In the embodiment depicted in Figure 4C , the outer surface of the box can be trapezoidal. In such an embodiment, the sides of the box 302 can include more than one surface, such as surfaces 410a, 410b, and 410c. The inner wall of the box 302 can optionally include reflective and / or light-scattering materials. For example, the inner wall of the box 302 or 414 can include high-gloss white nylon, thermoplastic resin, and / or porous polytetrafluoroethylene (“PTFE”). It may be desirable for the inner surface of the box 302 to be matte so that light reflected from the surface is scattered and / or diffused. The box can optionally include a diffuser. The diffuser can ensure the uniformity of illumination inside the box. The diffuser can include frosted plastic. The light source inside the box can provide uniform illumination and can be used in conjunction with a method that eliminates the need for factory calibration of the light source. For example, the illumination provided by the light source can be consistent enough that image processing of the mobile device eliminates the need for factory calibration of the light source.

[0087] Figure 4A An example light box 302 is shown that includes notches or protrusions that can hold a diagnostic test kit. In some embodiments, the light box can include notches or protrusions to assist in positioning and / or holding a diagnostic test kit. The notch 404 can serve as a holder for the diagnostic test kit on the bottom surface 406 of the box 302. In embodiments that include an insertion port, the notch and / or protrusion can be aligned with the insertion port. In some embodiments, the size of the notch and / or protrusion can be designed to receive and hold the diagnostic test kit within the imaging area of the box. In some embodiments, the box can include markings to guide the user in placing the diagnostic test kit inside the box. For example, such markings can include a contour line on the inner surface of the bottom of the box that indicates the location where the diagnostic test kit should be placed. In some embodiments, for example Figure 4BIn the embodiments depicted, the cassette may be capable of receiving a scan card 416. The scan card 416 may include printed markings. The printed markings may be used during analysis of the test device placed on the scan card and / or analysis of an image of the test device and the scan card. The printed markings may include, but are not limited to, printed reference colors, control markings, boundaries of image regions, and other features. The printed markings may be used to analyze the results of a test performed on the test device and / or the adequacy of illumination, orientation, and focusing conditions associated with an image of the test device. The scan card 416 may or may not include features of a carrier. For example, the scan card 416 may or may not include markings and / or adhesive patches for aligning and placing the test device 202. In some embodiments, the bottom surface 406 (including all or part of the notch 404) may be the scan card. During manufacture of the cassette 302, the markings may be pre-printed on the inner bottom surface. In such an example, the user may be instructed to place the test device 202 on a test placement guide provided (e.g., printed) on the inner bottom surface of the cassette 302. The test placement guide may be alignment markings identifying the location for placing the test device on the scan card. In such an example, a carrier may not be implemented.

[0088] Figure 4C The cassette 302 including a plurality of light sources is shown. It should be understood that embodiments of the light box according to the present disclosure may include any suitable light source, such as but not limited to an LED set. The LED set may include LED strips. Figure 4C Indicates the positioning of the plurality of light sources 412 (e.g., LED strips) within the cassette 302 for some embodiments. The plurality of light sources 412 may be positioned at an upper inner portion of the walls of the cassette 302.

[0089] In some embodiments, the chamber 302 can include a diffuser between the light source and the test device (such as test device 202). The diffuser can include a transparent or translucent material, such as frosted plastic, fiber / paper (such as rice paper), plastic with an etched surface, glass with an etched surface, lenses (especially Fresnel lenses), regularly spaced lenses, or randomly spaced lenses. The diffuser can be positioned or fixed to the light sources so that they are angled relative to the location (such as notch 404) where the test device can be placed. In some embodiments, the chamber 302 can be used as a camera with a mobile device 130 (such as a smartphone or tablet). In some embodiments, the aperture 402 at the top of the light box can facilitate using the light box with a wide range of mobile devices. In some embodiments, the aperture 402 at the top of the light box can be specific to a particular type of mobile device (e.g., a particular model or a group of particular models of mobile devices). In some embodiments, the aperture 402 at the top of the light box can accept an adapter, where the adapter is specific to one or more particular models of mobile devices and can fit within the aperture 402. In embodiments where a mobile device is used to image the test device, the frame 302 can include a mobile device placement marker to indicate to the user where the mobile device should be placed for imaging. Such a marker can include, for example, a contour on the outer surface of the chamber that indicates the location where the mobile device should be placed. In some embodiments, the chamber includes a dedicated camera mounted in a fixed position relative to the chamber.

[0090] The chamber 302 can include components for securing a plurality of light sources 412 inside the chamber 302. The components can be capable of securing the light sources 412 at a particular angle such that light is adequately transmitted to the location of the diagnostic test device during imaging. The components can secure the plurality of light sources 412 at an angle relative to the vertical direction. In some embodiments, the chamber 302 can include components for securing a plurality of light sources (such as one or more LED strips) in place inside the chamber 302, such as Figure 4A the element 408 shown in. The components can secure the plurality of light sources 412 at an angle relative to the vertical direction, such as one or more LED strips. In some embodiments, the element 408 can act as a diffuser for the plurality of light sources 412. In such embodiments, the element 408 can be transparent or translucent. In such embodiments, the element 408 can include frosted plastic. In some alternative embodiments, the element 408 is not a diffuser but is opaque. In such embodiments, the element 408 can be a bracket that can secure the plurality of light sources 412 while minimally or substantially not interfering with the transmission of light from the plurality of light sources.

[0091] Figure 5Shows a light box 302 with an integrated light source 412, the integrated light source 412 including an LED group. The LED group can face downward at an angle between 15° and 85° relative to the vertical direction. In some embodiments, the LED group can be at an angle of 45° relative to the vertical direction, as Figure 5 shown. Figure 5 Also shown are three different embodiments where the LED group is positioned at different heights due to different box heights. The height H includes the height H A , a height H A that is 0.5 inches greater than H B or an H A that is 1 inch greater than H C . When the test device 202 is positioned inside the box 302, the height H of the box can affect the illumination of the test device 202. The height H of the box 302 can match and / or exceed the ideal focal length of the mobile device camera 128. The height H can be specific to the mobile device model. For several models of mobile devices, the minimum focal length for generating a focused image can be about 15 cm, so in some embodiments, the box height H of the box 302 can be about 15 cm or greater.

[0092] Figure 6 Plotted are the light intensity measurements on the bottom surface of the box for three different horizontal distances 1, 2, and 3 between LED groups positioned at the center of the bottom surface of the box. Figure 6 The x-axis and y-axis of the plot in Figure 7 correspond to the pixel positions within the acquired image. As shown, the LED is 500 lux or 1500 lux. Figure 7 The x-axis and y-axis of the plot in Figure 3 correspond to the pixel positions within the acquired image. The light source can be at an angle relative to the vertical direction, for example, at an angle of 45° relative to the vertical direction. For example,

[0093] the example light box shown in

[0094] Figure 8A and Figures 9 - 10 shows a light box 302 that can include a tray 802 that can diffuse light. Specifically referring to Figure 8A, in some embodiments, the cassette may include a 3D printed and / or thermoformed tray 802 to serve as a diffuser for the light source 412 included in the cassette 302. When the thermoformed tray 802 is inserted Figure 8A into the cassette 302 as depicted. The light source 412 may be covered such that light must pass through the thermoformed tray 802 before reaching the test device 202. As Figure 8B shown, including light sources on four sides can provide more uniform illumination compared to a light box with light sources on two sides. Figure 9 A light box 302 without a thermoformed tray is depicted. As Figure 9 shown, the light source 412 may be attached to the inner wall of the cassette 302. Figure 10 An exemplary tray 802 is shown that can be inserted into the light box 302. The tray 802 may include a test device placement 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, where the test device 202 may be placed on the scan card 416. The test device placement area 804 may include markings for aligning the test device and / or imaging, as discussed herein with reference to the bottom surface of the cassette 302.

[0095] Figures 11A - 11F The tray 802 is depicted separately and inserted into the cassette 302. Figure 11A A side view of the tray 802 is shown. Figure 11B A bottom view of the tray 802 is shown. Figure 11C A bottom view of the tray 802 received in the cassette 302 is shown in an orientation to show the features at the bottom of the tray 802. Figure 11D A side view of the cassette 302 including a base 1104 and a lid 1106 is shown. Figure 11E A top view of the tray 802 located in the cassette 302 is shown. Figure 11F A top view of the tray 802 located in the cassette 302 is shown, where the scan card 416 is positioned within the tray 802. The test device 202 may be received on the scan card 416 located within the tray 802. The tray 802 may include a transparent or translucent material that can diffuse light. At least a portion of the tray 802 may be positioned between a plurality of light sources (here LED strips 1102) and the test device 202, as Figure 11F shown. The LED strips 1102 may be positioned on and / or attached to the tray 802. The LED strips 1102 may be positioned on the lower side of the tray 802 and / or attached to the lower side of the tray 802. Figure 11B and Figure 11C Such an attachment of the LED strips 1102 to the tray 802 is shown. The LED strips 1102 may be positioned on the tray 802 such that when the tray 802 is positioned within the cassette 302, asFigure 11E and Figure 11F As depicted by Figure 11F , the LED 1102 is positioned near the upper corner inside the cassette 302.

[0096] In embodiments including both the tray 802 and the insertion port, the tray 802 may include a loading aperture to allow a test device to be inserted into the tray 802 from the exterior of the cassette 302 via the insertion port. When the tray 802 is inserted into the cassette 302, the loading aperture may be aligned with the insertion port. The size and shape of the loading aperture may be designed to allow the test device to pass through while minimizing the transmission of non-diffused light through the loading aperture. In some examples, the size and shape of the loading aperture may be designed to be approximately as large as the profile cross-section of the test device, with a clearance around the test device of less than or up to 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 mm or greater when loaded, or any value within a range defined by any two of the foregoing values.

[0097] Figure 11D A side view of the cassette 302 including the base 1104 and the lid 1106 is shown. The lid 1106 may include an imaging aperture that may allow the mobile device to image the test device 202. The lid 1106 may be removable. The lid 1106 may be removed to facilitate placement of the tray 802 and / or the test device 202.

[0098] In some embodiments where the plurality of light sources 412 includes an LED group, 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 within the cassette. It should be understood that other quantities of LEDs may be suitably implemented. The LED group may include LEDs spaced apart from each other by about 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 greater 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 each other by at least about 1 cm. The total number of LEDs, the spacing of the LEDs, the intensity of the LEDs, and the size and / or shape of the cassette 302 may all be selected such that the illumination within the cassette 302 is suitably bright and diffused during imaging. The size of the test assay cassette may also be considered when selecting the total number of LED lights, the LED light intensity, the spacing of the LED lights, and the size of the cassette. Other types of light sources may also be suitably implemented in the light box according to the present disclosure in addition to or instead of the LED light source.

[0099] Some embodiments include differential illumination provided by multiple alternative light sources, such as different LED groups. Each light source (e.g., each LED group) can be set to emit a specific wavelength and / or wavelength range to optimize the readout of diagnostic tests. The emission wavelengths and / or wavelength ranges of the light sources can be different. As a non-limiting example, multiple LED lights can be configured to provide white light, while another multiple LED lights can be configured to provide light within a narrower frequency range of visible or invisible light. These alternative light sources can be used to enhance the contrast or emission of conjugate materials used in next-generation diagnostic assays.

[0100] Fluorescent image detection

[0101] Although the cassette 302 has been described primarily in the context of colorimetric and reflectance assay modes, the cassette 302 can be used to allow for fluorescent image detection by incorporating the correct excitation and emission filters. In some such embodiments, the diffuser tray 802 can include an excitation filter that can allow light of a wavelength or wavelength range that can excite the fluorophores of the test device to pass through. In some such embodiments, the multiple light sources 412 can be capable of emitting light at the excitation wavelength rather than the emission wavelength. In either case, the excitation light can thus be transmitted from the multiple light sources to the test device. The aperture 402 can include an emission filter that can allow light of a wavelength or wavelength range emitted by the fluorophores of the test device to pass through. Thus, the light emitted by the fluorophores can be transmitted through the emission filter to the mobile device camera.

[0102] Sintered optical components in diagnostic test hardware

[0103] As described above, in various embodiments, it may be desirable to improve the uniformity or homogeneity of the illumination light within the light box. Accordingly, aspects of the present disclosure relate to materials for inclusion within a light box according to the present disclosure, such as sintered polymers. In some embodiments, sintered polymers can be used within the disclosed light box, for example, as a lining, coating, and / or inner surface of the light box. Sintered polymers (more specifically, sintered polymer-based reflectors) provide another technical platform with many attractive features for use in diagnostic test hardware.

[0104] A Lambertian surface can have nearly constant light reflection, independent of the angle of the incident light. Figure 12AThis phenomenon is schematically illustrated, where the angle of the reflected beam 1206 from the Lambert reflector 1202 is independent of the angle of the incident beam 1204. Reflectors based on sintered polytetrafluoroethylene (“PTFE”) are an example of Lambert reflectors. Some such materials have nearly constant reflectance over a wide wavelength range (e.g., 250 - 2500 nm or from ultraviolet (UV) to mid-infrared (MIR)). In the spectral range of 300 - 1500 nm, such materials can achieve reflectance values up to 99%. In some embodiments, the high reflectivity of sintered PTFE can eliminate the need for a diffuser between the light source of the light box and the surface to be imaged.

[0105] The sintered PTFE coating can have various properties such that it can be used to coat the interior of the light box of the present disclosure. The sintered PTFE polymer reflector has a nearly constant transmittance and absorbance from about 275 nm to about 500 nm, as Figure 12B shown. Additionally, the proportion of the reflected light can be independent of the thickness of the PTFE layer. For a given layer thickness, the sintered PTFE polymer reflectance varies little as a function of the median pore diameter in the range of about 2 μm to 6 μm, as Figure 13 shown.

[0106] The results from a series of imaging experiments are shown in Figures 14A - 14C to illustrate the impact of sintered PTFE in applications for improving the lighting uniformity inside the light box according to various embodiments of the present disclosure. Figure 14A A top view of the light box 500 made of brown cardboard is shown. Its dimensions are approximately 315 mm by 180 mm by 125 mm, and there is an opening window 510 of 50 mm by 30 mm on the top surface, in which a smartphone 520 is placed. The smartphone 520 has: an F / 1.7, 12 - megapixel camera lens and a built-in white LED. The focusing distance set in the light box 500 for imaging by the smartphone 520 is approximately 120 mm within a FOV of about 103 mm by 77 mm.

[0107] The imaging experiment consists of two phases. During Phase 1, the inner surface of the light box 500 is entirely covered with white paper cut from standard A4 printer paper. An image captured by the smartphone with automatic exposure control during LED flash illumination is shown as Figure 14B shown, where a test box 530 with a length of approximately 96 mm is located at the center within the imaging FOV, and a selected region of interest 540 for lighting analysis, from which the average profile of the lighting along the horizontal direction is calculated and plotted below the selected region. As Figure 14BAs shown, the illumination within the FOV is relatively non-uniform because the illumination profile along the horizontal direction is not flat but curved.

[0108] During Phase 2, the inner surface of the light box 500 is entirely covered with sintered PTFE cut from a 0.5 mm sheet (3M 300LSE). With all other imaging conditions being the same, an image captured by a smartphone with automatic exposure control during LED flash illumination is as Figure 14C shown, where the same test cassette 530 is located at the center within the imaging FOV, and similarly, the selected region of interest for illumination analysis is denoted as 540, from which the average profile of the illumination along the horizontal direction is calculated and plotted below the selected region. As Figure 14C shown, in the case where the inner surface of the light box 500 is coated with sintered PTFE material, the illumination within the FOV not only becomes more uniform but also the illumination intensity increases by approximately 5%.

[0109] The PTFE-based sintered reflector material can be used with various embodiments of the light boxes disclosed herein to improve image generation in various test devices. For example, the PTFE-based sintered reflector material can be used with home tests that use mobile devices, such as smartphone cameras and apps, to capture and interpret results, thereby eliminating the human subjectivity in other visually read home diagnostic tests. Porous PTFE (e.g., porous ) is an example sintered polymer material that can be suitably implemented in the light boxes according to the present disclosure. Additionally, PTFE has antioxidant properties, which ensure that it does not turn yellow or fade during its shelf life.

[0110] An example test used with the light box including sintered PTFE is the albumin-to-creatinine ratio (ACR) test. The ACR test utilizes the printed reference colors on the cassette / image for color correction. A densitometer under D65 illumination settings can be used to establish the ground truth color information (gtXYZ) of the printed reference colors. Test images captured under different illumination conditions may exhibit significant deviations in test results after the color correction process. It has also been observed that there is non-uniform illumination on the cassette when there are shadows or non-uniform illumination conditions. Factors such as non-uniform illumination, shadows, and glare can affect the color correction process. Additionally, higher variations in albumin and creatinine readings can be observed under low light or fluorescent conditions. This situation may result in error messages for the end user stating that the captured image cannot be read. This can cause frustration for the end user and hinder the widespread adoption of point-of-care tests (such as the ACR test). Overview of sintered optical components used with the light box

[0111] The PTFE-based sintered reflector can be included within a box (e.g., a light box) according to the present disclosure.Figure 15A and Figure 15B shows the exterior of such a light box. Figure 15C shows a view through the aperture of such a box after an insert or carrier (such as, but not limited to, a scan card 416) and a test device 202 have been received in the box. The PTFE-based sintered reflector layer can improve the light distribution uniformity in any type of light box. Embodiments of a light box with a PTFE-based sintered reflector can include a light box according to the present disclosure that includes a built-in light source and / or an imaging device. Each embodiment can include a light box according to the present disclosure that is a disposable box that can be used as a package.

[0112] In some embodiments, at least one inner surface of the box includes a sintered PTFE polymer layer. In some embodiments, some or all of the inner surfaces of the box (such as the bottom surface, side surfaces, and / or top surface inside the box) include a sintered PTFE polymer layer. In some embodiments, an insert or cassette carrier with sintered PTFE polymer can be included in the light box. In one example, a user removes a scan card 416 from a box 302, positions a test cassette on the scan card 416, and reinserts the scan card 416 with the test cassette into the box for analysis. In some embodiments, a box including a sintered PTFE polymer layer can include one or two open ends. The PTFE layer can be a thin layer, film, etc. Suitable layer thickness ranges for sintered PTFE can be between 0.2 mm and 2.0 mm, between 0.5 and 1.0 mm, and / or less than 0.5 mm, but other ranges or values may be suitable. In certain embodiments, a suitable sintered PTFE layer thickness range can be 0.2 mm to 1.0 mm. When using a light source (such as the flash LED of a mobile device or an internal light source disposed inside the light box), homogeneous and consistent illumination conditions for colorimetric testing are provided on the printed reference color of the carrier (if a printed reference color for colorimetric testing is included on the carrier) and for cassette imaging. The PTFE-based sintered reflector material can thus help improve the cassette image obtained for diagnostic testing.

[0113] A light box incorporating a PTFE-based sintered reflector according to the present disclosure can advantageously implement a packaging configuration with a reduced profile or volume while maintaining an improved light distribution in an assembled use configuration. In one non-limiting example, the kit includes a light box in the form of a flat-folded box. The light box can include any of the features described herein, including but not limited to a window for image capture and alignment marks. The kit can optionally include a test cradle and test device (e.g., a diagnostic test, such as an assay test strip). The test cradle and test device can be packaged within the flat-folded box or can be packaged together with the flat-folded box. In one non-limiting example, the kit includes a mobile device configured to image and interpret diagnostic tests. The kit can also include instructions for the user to assemble the flat-folded box from a flat-packaged configuration into a three-dimensional assembled configuration by popping the box out at pre-creased folds into a 3-sided, 4-sided, 5-sided, or 6-sided box. The flat-folded box can include pre-placed adhesives to hold the box in the three-dimensional assembled configuration. In the flat-packaged configuration, the flat-folded box can be used very compactly for transportation, storage, and display. In the three-dimensional assembled configuration, the flat-folded box can have an optimized height (such as but not limited to a height of 15 cm) to generate focused images using various mobile devices. In one non-limiting example, the flat-folded box transforms into a quadrilateral box open at both ends. The inner surface of the box can be coated with a PTFE-based sintered reflector that can optimize the light distribution within the light box, as described above. Embodiments of light boxes that can be transported in a flat configuration and assembled into a box with optimal height and light distribution properties when in use can advantageously reduce manufacturing, transportation, and storage costs.

[0114] Terms

[0115] 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 terms "comprising" and other forms thereof, such as "include", "including", and "containing", are not restrictive. The term "having" and other forms thereof, such as "has", "with", and "had", are not restrictive. The terms "comprising", "including", "having", etc. are synonyms and are used in an open-ended manner to include additional elements, features, acts, operations, etc. That is, the above terms should be interpreted synonymously with the phrase "at least having" or "at least including". For example, when used in the context of a process, the term "comprising" means that the process includes at least the recited steps, but may include additional steps. When used in the context of a device, the term "comprising" means that the device includes at least the recited features or components, but may also include additional features or components. In addition, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list. In addition, the term "each" as used herein, in addition to having its ordinary meaning, may also refer to any subset of a group of elements to which the term "each" is applied.

[0116] Unless otherwise specifically stated, conjunctive language such as the phrase "at least one of X, Y, and Z" is understood as commonly used in the context to convey items, terms, etc., which can be any one of X, Y, or Z. Thus, such conjunctive language generally does not purport to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0117] The term "and / or" as used herein has the broadest lowest restrictive meaning, i.e., the present disclosure includes A alone, B alone, A and B together, or alternatively A or B, but does not require the simultaneous presence of A and B, nor does it require one of A or one of B. As used herein, the phrase "at least one of A, B, and C" should be interpreted using the non-exclusive logic "or" to mean logic A or B or C.

[0118] Unless otherwise specifically stated or otherwise understood in the context in which it is used, conditional language used herein, such as "can", "could", "may", or "might", is intended to express in its ordinary sense that certain features, elements, and / or steps are optional. Thus, such conditional language generally is not intended to imply that features, elements, and / or steps are required in any way. The terms "comprising", "including", "having", etc. are used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that, for example, when used to connect a list of elements, the term "or" means one, some, or all of the elements in the list.

[0119] Any method disclosed herein need not be performed in the order described. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instructions for such actions, whether explicit or implicit.

[0120] Some or all of the methods and tasks described herein can be performed by a computer system and fully automated. A diagnostic test system according to the present disclosure can include a computer system which, in some cases, can include multiple different computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate via a network to perform the described functions. Each such computing device generally includes a processor (or processors) that executes program instructions or modules stored in a memory or other non-transitory computer-readable storage medium or device (e.g., solid-state storage device, disk drive, etc.). The various functions disclosed herein can be embodied in such program instructions and / or can be implemented in the dedicated circuitry (e.g., ASIC or FPGA) of the computer system. In cases where the computer system includes multiple computing devices, these devices can, but need not, be located in the same location. The results of the disclosed methods and tasks can be persistently stored by transforming a physical storage device such as a solid-state memory chip and / or disk into a different state. The computer system can be a cloud-based computing system whose processing resources are shared by multiple different commercial entities or other users.

[0121] Although the foregoing detailed description has shown, described, and pointed out novel features, it is to be understood that various omissions, substitutions, and changes in the form and details of the devices, systems, and methods may be made without departing from the spirit of the present disclosure. It will be recognized that some portions of the description herein may be embodied in forms that do not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from other features. Accordingly, the present disclosure is not intended to be limited to the particular embodiments disclosed herein but covers all modifications and alternative arrangements within the true scope and spirit of the present disclosure.

Claims

1. A light box for imaging a diagnostic test device, the light box comprises: a box structure configured to package the diagnostic test device before using the diagnostic test device, the box structure comprising: a plurality of side walls and an upper surface defining an internal volume; and at least one aperture in the upper surface configured to allow a mobile device to image the diagnostic test device through the aperture when the diagnostic test device is disposed within the internal volume.

2. The light box according to claim 1, further comprising a bracket sized and shaped to fit within the internal volume of the light box, and the bracket is configured to facilitate positioning the diagnostic test device within the light box for imaging by the mobile device.

3. The light box according to claim 2, wherein, the bracket comprises an adhesive configured to fix the diagnostic test device to the bracket.

4. The light box according to claim 2, wherein, the bracket comprises at least one alignment mark identifying a position for placing the diagnostic test device on the bracket.

5. The light box according to claim 1, wherein, the at least one aperture comprises a transparent window, and wherein the mobile device at least partially rests on the transparent window.

6. The light box according to claim 1, wherein, the upper surface is configured to support the mobile device when the mobile device images the diagnostic test device through the aperture.

7. The light box according to claim 1, further comprising a polytetrafluoroethylene (PTFE) polymer coating on at least one inner surface of the box structure.

8. The light box according to claim 1, wherein, the at least one aperture is sized and shaped to simultaneously accommodate image capture by a camera of the mobile device and illumination of the diagnostic test device by a light emitter of the mobile device.

9. The light box according to claim 1, wherein, the at least one aperture comprises a first aperture and a second aperture, the first aperture being sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model of mobile device having a first camera and flash configuration, and the second aperture being sized and shaped to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model of mobile device having a second camera and flash configuration.

10. The light box according to claim 1, wherein, the upper surface comprises at least one alignment mark identifying a position for placing the mobile device on the upper surface.

11. The light box according to claim 1, further comprising a light diffuser located above or below the aperture.

12. The light box according to claim 11, wherein, the light diffuser is fixed to a bottom surface of a transparent window at least partially covering the aperture.

13. The light box according to claim 1, further comprising a removable protective cover covering at least a portion of the aperture.

14. The light box according to claim 1, wherein, The light box is configured to be foldable between a transport configuration having a first height and an imaging configuration having a second height greater than the first height, the second height corresponding to the imaging focal length of the mobile device.

15. The light box according to claim 1, wherein, the upper surface is recessed from the top surface of the box structure and is configured to receive and hold the mobile device.

16. A light box for imaging a diagnostic test device, the light box comprising: a box structure including at least one aperture configured to allow a mobile device to image the diagnostic test device from a distance; and a plurality of light sources positioned within the internal volume of the box structure.

17. The light box according to claim 16, wherein, the light sources include a plurality of LEDs.

18. The light box according to claim 17, wherein, the light sources include one or more LED strips.

19. The light box according to claim 17, wherein, the plurality of LEDs includes 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.

20. The light box according to claim 17, wherein, the plurality of LEDs includes a first plurality of LEDs disposed along a first inner side of the light box and a second plurality of LEDs disposed along a second inner side of the light box opposite the first inner side.

21. The light box according to claim 17, further comprising a third plurality of LEDs disposed along a third inner side of the light box and a fourth plurality of LEDs disposed along a fourth inner side of the light box.

22. The light box according to claim 16, including a diffuser configured to diffuse light from the light sources within the light box.

23. The light box according to claim 22, wherein, the diffuser includes a tray shaped and sized to receive the diagnostic test device in a position aligned with the imaging area.

24. The light box according to claim 23, wherein, the tray includes frosted plastic.

25. The light box according to claim 23, wherein, the tray includes thermoformed plastic or 3D printed plastic.

26. The light box according to claim 17, wherein, the plurality of LEDs are positioned to face downward at an angle between 15° and 85° relative to the vertical direction.

27. The light box according to claim 26, wherein, the plurality of LEDs are positioned to face downward at 45° relative to the vertical direction.

28. The light box according to claim 17, wherein, the spacing between adjacent LEDs among the plurality of LEDs is approximately 1 centimeter.

29. The light box according to claim 16, wherein, The box structure includes a plurality of sidewalls and an upper surface that define the interior volume, and wherein the at least one aperture is provided in the upper surface and is configured to allow the mobile device to image the diagnostic test device through the at least one aperture when the diagnostic test device is disposed within the interior volume.

30. The light box according to claim 16, wherein, the box structure includes a base and a lid, and wherein the at least one aperture is provided within the upper surface of the lid.

31. The light box according to claim 30, wherein, the box structure is configured to receive the diagnostic test device into the base when the lid is removed from the box structure.

32. The light box according to claim 16, wherein, the box structure is configured to receive the diagnostic test device through an opening in a sidewall of the box structure.

33. A light box for imaging a diagnostic test device, the light box comprising: a box structure configured to deploy from a transport configuration to an imaging configuration for use with the diagnostic test device, the box structure including: a plurality of sidewalls and an upper surface that define an interior volume; and at least one aperture in the upper surface configured to allow a mobile device to image the diagnostic test device through the aperture when the diagnostic test device is disposed within the interior volume.

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

35. The light box according to claim 34, wherein, the cradle includes an adhesive configured to secure the diagnostic test device to the cradle.

36. The light box according to claim 34, wherein, the cradle includes at least one alignment mark that identifies a location for placing the diagnostic test device on the cradle.

37. The light box according to claim 33, wherein, the at least one aperture includes a transparent window, and wherein the mobile device at least partially rests on the transparent window.

38. The light box according to claim 33, wherein, the upper surface is configured to support the mobile device when the mobile device images the diagnostic test device through the aperture.

39. The light box according to claim 33, further comprising a polytetrafluoroethylene (PTFE) polymer coating on at least one inner surface of the box structure.

40. The light box according to claim 33, wherein, the at least one aperture is sized and shaped to simultaneously accommodate image capture by a camera of the mobile device and illumination of the diagnostic test device by a light emitter of the mobile device.

41. The light box according to claim 33, wherein, The at least one aperture includes a first aperture and a second aperture, wherein the size and shape of the first aperture are designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a first model of mobile device having a first camera and flash configuration, and the size and shape of the second aperture are designed to accommodate simultaneous illumination and imaging of the diagnostic test device by a second model of mobile device having a second camera and flash configuration.

42. The light box according to claim 33, wherein, the upper surface includes at least one alignment mark that identifies a position for placing the mobile device on the upper surface.

43. The light box according to claim 33, further comprising a light diffuser located above or below the aperture.

44. The light box according to claim 43, wherein, the light diffuser is fixed to the bottom surface of a transparent window that at least partially covers the aperture.

45. The light box according to claim 33, further comprising a removable protective cover covering at least a portion of the aperture.

46. The light box according to claim 33, wherein, the transportation configuration has a first height and the imaging configuration has a second height greater than the first height, and the second height corresponds to the imaging focal length of the mobile device.

47. The light box according to claim 33, wherein, the upper surface is recessed from the top surface of the box structure and is configured to receive and hold the mobile device.

48. The light box according to any one of claims 1 to 47, wherein, the box structure is reusable.

49. The light box according to any one of claims 1 to 47, wherein, the box structure is disposable.

50. The light box according to any one of claims 1 to 47, further comprising the diagnostic test device disposed within the internal volume.

51. The light box according to any one of claims 1 to 47, wherein, the light box is a transportation container for the diagnostic test device.

52. A method of imaging a test device, comprising: deploying a light box from a transportation configuration to an imaging configuration, wherein the light box includes an aperture; placing the test device within the light box in the imaging configuration; and imaging the test device using a mobile device.

53. The method according to claim 52, further comprising removing a lid from the aperture of the light box.

54. The method according to claim 52, further comprising aligning the camera of the mobile device with the aperture.

55. The method according to claim 52, further comprising aligning the test device with the aperture.

56. The method according to claim 52, further comprising placing the mobile device on the surface of the light box.

57. The method according to claim 52, wherein, placing the test device within the light box includes placing the test device on a tray and inserting the tray into the light box.

58. The method according to claim 57, further comprising adhering the test device to the tray.

59. The method according to claim 52, wherein, in the imaging configuration, the light box has a height greater than or equal to the focal length of the mobile device.

60. The method according to any one of claims 52 to 59, wherein, the box structure is reusable, and the method further includes reusing the light box.

61. The method according to any one of claims 52 to 59, wherein, the box structure is disposable, and the method further includes disposing of the light box.

62. The method according to any one of claims 52 to 59, wherein, the diagnostic test device is disposed within the internal volume in the transport configuration.

63. The method according to any one of claims 52 to 59, wherein, the light box is a transport container for the diagnostic test device.

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