Systems and methods for remote evaluation of sample assays for disease diagnosis

Abstract

A circuit within the image capture device is provided. The circuit includes a light source controller configured to provide a signal to a light source when a cartridge mount receives a test cartridge inside the dark chamber. The circuit also includes a sensor array controller configured to activate at least one pixel in a sensor array when the light source is activated and to receive a signal from the at least one pixel, the signal indicating an optical intensity of light emitted from the test cartridge. The circuit also includes a processor configured to form a transmittable file having the signal from the at least one pixel and a radio frequency antenna configured to transmit the transmittable file to an external processor.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 035,219, filed June 5, 2020, and U.S. Provisional Patent Application No. 63 / 031,989, filed May 29, 2020, the contents of which are incorporated herein by reference in their entireties.

[0002] Technical Field The present disclosure relates generally to devices and methods for home testing, telemedicine applications, and other in situ immunoassay measurement. More particularly, the present disclosure relates to consumables that can be used in simple and accurate procedures to locally and / or remotely assess disease diagnostics in connection with client devices used by consumers. [Background technology]

[0003] background Currently, disease diagnosis using test assays involves users sending test samples to a laboratory for accurate analysis. This step is time-consuming because it involves the physical movement of test cartridges (containing the test sample, also called sample cartridges) back and forth between a healthcare provider (e.g., a clinic, physician, or pharmacy), the laboratory, and the user (prior to using the test sample). Furthermore, these test samples often tend to create unnecessary delays within the clinical laboratory (since many samples may be negative). Furthermore, the time lag between testing and results can be a potential cause, for example, during epidemic or pandemic emergencies, or when the timing of treatment initiation dramatically impacts the outcome of treatment for a serious condition, or when an infected user leaves the office without immediate results, thereby missing follow-up and potentially infecting others. [Brief explanation of the drawings]

[0004] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1]

[0004] An architecture including a remote server, a database, and an image capture device for collecting images from a test cartridge in an enclosure is shown, according to some embodiments. [Figure 2]

[0005] 1 illustrates an enclosure and other internal components within an image capture device, according to some embodiments. [Figure 3A]

[0006] 1 illustrates an optical chassis and cartridge mount in an image capture device according to one embodiment. [Figure 3B] 1 illustrates an optical chassis and cartridge mount in an image capture device according to one embodiment. [Figure 3C] 1 illustrates an optical chassis and cartridge mount in an image capture device according to one embodiment. [Figure 3D] 1 illustrates an optical chassis and cartridge mount in an image capture device according to one embodiment. [Figure 4A]

[0007] 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 4B]

[0007] FIG. 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 4C]

[0007] FIG. 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 4D]

[0007] FIG. 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 4E]

[0007] FIG. 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 4F]

[0007] FIG. 1 illustrates a cross-sectional view of an enclosure, cartridge mount, optical chassis, and sensor array in an image capture device, according to one embodiment. [Figure 5A]

[0008] 1 illustrates a top-down view of a cartridge mount with or without a test cartridge in an image capture device, where the test cartridge includes a read zone bounded by a boundary, according to one embodiment. [Figure 5B]

[0008] Figure 1 illustrates a top-down view of a cartridge mount with or without a test cartridge in an image capture device, according to one embodiment, where the test cartridge includes a read zone bounded by a boundary. [Figure 5C]

[0008] Figure 1 illustrates a top-down view of a cartridge mount with or without a test cartridge in an image capture device, according to one embodiment, where the test cartridge includes a read zone bounded by a boundary. [Figure 6A]

[0009] 1 illustrates a cross-sectional view of the general layout of optical components and an illumination pattern formed on a test cartridge within an image capture device, according to one embodiment. [Figure 6B]

[0009] FIG. 1 illustrates a cross-sectional view of the general layout of optical components and an illumination pattern formed on a test cartridge within an image capture device, according to one embodiment. [Figure 6C]

[0009] FIG. 1 illustrates a cross-sectional view of the general layout of optical components and an illumination pattern formed on a test cartridge within an image capture device, according to one embodiment. [Figure 7A]

[0010] 1 illustrates different designs and models for test cartridges used in an image capture device, according to one embodiment. [Figure 7B] 1 illustrates different designs and models for test cartridges used in image capture devices, according to one embodiment. [Figure 7C] 1 illustrates different designs and models for test cartridges used in image capture devices, according to one embodiment. [Figure 7D] 1 illustrates different designs and models for test cartridges used in image capture devices, according to one embodiment. [Figure 7E] 1 illustrates different designs and models for test cartridges used in image capture devices, according to one embodiment. [Figure 8A]

[0011] 1 illustrates a test cartridge receptacle including a presence sensor within an image capture device, according to one embodiment. [Figure 8B] 1 illustrates a test cartridge receptacle including a presence sensor within an image capture device, according to one embodiment. [Figure 9]

[0012] 1 is a perspective view of a cartridge mount including a light shield, a leaf spring, and a door actuation lever for receiving a test cartridge within an enclosure of an image capture device, according to some embodiments. [Figure 10]

[0013] 1 is a close-up perspective view of a test cartridge inserted within a cartridge mount of an image capture device, according to some embodiments. [Figure 11A]

[0014] 1 illustrates a system block diagram of electronic components within an image capture device, according to one embodiment. [Figure 11B] 1 illustrates a system block diagram of electronic components within an image capture device, according to one embodiment. [Figure 11C] 1 illustrates a system block diagram of electronic components within an image capture device, according to one embodiment. [Figure 12]

[0015] 1 shows a block diagram of an interface between a microcontroller and a sensor array in an image capture device, according to some embodiments. [Figure 13A]

[0016] 1 shows a block diagram of a power distribution unit in an image capture device, according to one embodiment. [Figure 13B] 1 shows a block diagram of a power distribution unit in an image capture device, according to one embodiment. [Figure 14]

[0017] 1 illustrates a timing diagram including signal and power waveforms within an image capture device, according to some embodiments. [Figure 15]

[0018] 1 illustrates a temperature sensor circuit diagram and key waveforms for driving the temperature sensor, according to some embodiments. [Figure 16]

[0019] 1 illustrates a driver circuit for a light source in an image capture device, according to some embodiments. [Figure 17A]

[0020] 1 illustrates an antenna interface and radio block diagram in an image capture device, according to one embodiment. [Figure 17B] 1 illustrates an antenna interface and radio block diagram in an image capture device, according to one embodiment. [Figure 18]

[0021] 1 illustrates a mask having multiple portions used to filter light received by a sensor array in an image capture device, according to some embodiments. [Figure 19]

[0022] 1 is a flowchart illustrating steps of a method for determining the presence or absence of an analyte of interest, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0005]

[0023] In the several figures, features or blocks with the same or similar labels have the same or similar content unless stated otherwise.

[0006] Detailed Description

[0024] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. However, it will be apparent to those skilled in the art that embodiments of the present disclosure may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the present disclosure.

[0007]

[0025] In the growing area of ​​telemedicine, it is becoming increasingly desirable to take advantage of the near-universal availability of electronic appliances, which can have wireless network access and sensors, as well as increasingly sophisticated computing power. Furthermore, some applications of remote measurement of immunoassays designed for the detection of chemical and biological agents or pathogens may include security testing and screening (e.g., at airports, police, and military checkpoints) or environmental analysis and monitoring (e.g., air pollution, contamination of waterways and reservoirs for disease control or agricultural production, and the like).

[0008]

[0026] Embodiments consistent with the present disclosure leverage the high image capture and processing capabilities of current consumer appliances to provide simple yet accurate diagnostic procedures for selected diseases (e.g., Legionella, influenza, Ebola, Lyme disease, SARS-CoV2, and the like). Test types consistent with embodiments in the present disclosure can include, without limitation, any type of spectroscopic analysis of test assays using electromagnetic radiation, such as absorption spectroscopy (ultraviolet, visible, or infrared), including reflectance or transmittance spectroscopy, or emission spectroscopy, including fluorescence and luminescence spectroscopy, Raman spectroscopy, and any type of radiation scattering. Furthermore, embodiments disclosed herein can further leverage the networking capabilities of such appliances to improve the throughput of each test by using cloud computing solutions. Thus, in some embodiments, high-quality (e.g., high spatial and spectral resolution) images, sequences of images, or videos are uploaded to a remote server that can perform massively parallel computing to provide diagnostic results in reduced time. Such analyzed material can be processed immediately, at a later date and / or compared to previously collected material to determine differences over time, such as, for example, temporal changes in analytes across a test strip. In other cases, the ability to collect and compile data libraries can enable the generation of self-teaching algorithms (artificial intelligence or machine learning algorithms) from the analysis of such image libraries to generate initial versions and improved versions as such libraries grow in size and diversity.

[0009]

[0027] The subject system offers several advantages, including the ability for users to quickly learn whether a disease is present or potential, without the need for specialized personnel or access to complex machinery or instruments.

[0010]

[0028] In some embodiments, the subject systems include immunodiagnostic analysis systems used in conjunction with fluorescent immunodiagnostic assay (FIA) test cartridges. Thus, the subject systems can include a compact reader device and software that resides (as a custom application) within a smartphone. Test interpretation can be performed autonomously within the phone application. Additionally, data and results can be uploaded from the smartphone to a dedicated database.

[0011]

[0029] Some embodiments offer the advantage of vastly expanding the market for medical test kits, as consumers with widespread access to mobile computing devices and other appliances may desire to perform tests before even perceiving any symptoms or visiting a doctor or clinic. This can also provide the advantage of a screening step before people visit a clinic or saturate the resources of a given medical facility. Furthermore, the cost of testing for remote users of the methods disclosed herein can be significantly less than the costs associated with visiting a clinic or laboratory, which can involve wait times, scheduling, obtaining an appointment away from actual infected patients, or exposing healthy patients to waiting rooms full of sick people.

[0012]

[0030] The proposed solution further provides an improvement to computer (e.g., server or user mobile device) operations because it saves data storage space and transaction time by enabling remote transmission of image analysis data and results (e.g., photographs, sequences of photographs, and / or videos).

[0013]

[0031] While many of the examples provided herein describe the downloading and storage of a user's personal information and data or a user's interaction history with one or more remote clinics as identifiable, each user can grant explicit permission for such user information to be provided or stored. Explicit permission can be granted using privacy controls integrated into the disclosed system. Each user may be provided with notice that such user information will be provided with their explicit consent, and each user can terminate information sharing and delete any stored user information at any time. Furthermore, in some embodiments, stored user information can be encrypted to protect the user's security and identity.

[0014]

[0032] In some embodiments, it is desirable for the image capture devices disclosed herein to have a useful life of more than two "seasons," where there is a utilization rate of 4 months / season and 3 tests / day. Accordingly, the electronic components in the embodiments disclosed herein can be selected to have good durability over the desired lifespan. In some embodiments, the usage of the image capture devices disclosed herein can be selected to result in more than several hundred tests (e.g., more than 720 tests in 2 seasons x 4 months / season x 30 days / month x 3 tests / day), more than -1920 hours of operation by assuming the device is left in a powered-on state for 8 hours / day, and a light source life of more than 1440 seconds (by assuming the ultraviolet light emitting diode (UV LED) is nominally left in an "on" state for 2 seconds per test).

[0015]

[0033] FIG. 1 illustrates an architecture 10 including a remote server 130, a database 152, a client device 110, and an image capture device 100A for collecting images or videos from a test cartridge 101, according to some embodiments. In some embodiments, the image capture device 100A is designed to work with most or all commercially available FIA ​​test cartridges and can be used with essentially any assay developed on these test cartridges. The client device 110 can include a smartphone or other mobile computing device (e.g., a tablet, pad, watch such as the Apple watch (iWatch™), or similar, or possibly a Bluetooth-enabled device such as a laptop). The architecture 10 provides an accurate assessment of the presence or absence of one or more target analytes in a test sample in real time from the assay results. The assays can be run within the test cartridge 101 and can include immunoassays for detecting one or more analytes of interest in a biological sample. The test cartridge 101 can provide a substrate for flowing a biological sample over multiple test channels for the detection of 1 to 20 (or more) analytes of interest. Images of the assay as it progresses may be provided by an image capture device 100A communicatively coupled to the client device 110.

[0016]

[0034] In one embodiment, the test cartridge 101 is an immunoassay test strip enclosed in a housing or cartridge for ease of handling. In other embodiments, the test cartridge 101 is simply an immunoassay test strip, such as a dipstick. That is, the outer housing is optional, and if present, need not be a cartridge or test cartridge housing, but may be a flexible laminate such as that disclosed in U.S. Patent Application Publication No. 2009 / 02263854 and shown in Design Patent No. D606664. The immunoassay test strip, in one embodiment, has, in order, a sample pad, a label pad, one or more lines or bands selected from a test line, a control line, and a reference line, and an absorbent pad. In some embodiments, a support member is present, and each or some of the sample pad, label pad, lines, and absorbent pad are disposed on the support member. Exemplary immunoassay test strips are described, for example, in U.S. Patent Nos. 9,207,181, 9,989,466, and 10,168,329, and in U.S. Patent Application Publication Nos. 2017 / 0059566 and 2018 / 0229232, each of which is incorporated herein by reference. Further details regarding immunoassay test strips are provided below.

[0017]

[0035] In some embodiments, the assay is an immunoassay that includes reagents for the detection of infectious agents (e.g., viruses or bacteria) in a biological sample. In some embodiments, the immunoassay includes reagents for the detection of proteins, including antibodies or small molecule biomarkers or autoantibodies, against specific analytes. In some embodiments, the analytes of interest are detectable by the emission of a unique signal associated with each analyte selected from the analytes of interest. In some embodiments, the biological sample includes a bodily fluid (e.g., blood, serum, plasma, sputum, nasal secretions, saliva, tears, feces, or urine). In some embodiments, the biological sample is human, and the presence of one or more target analytes may indicate a medical diagnosis of the individual providing the sample. Thus, in some embodiments, the architecture 10 includes a user of a client device 110 who has ordered a kit including a test cartridge 101 and an image capture device 100A, and is ready to perform personal testing for a disease or condition at a location away from a hospital or clinic (e.g., at home, a pharmacy, a retail store, a doctor's office, and the like).

[0018]

[0036] In architecture 10, image capture device 100A includes enclosure 120 to prevent ambient light from disrupting or interfering with measurements. In some embodiments, image capture device 100A wirelessly transmits images of test cartridge 101 to client device 110. Client device 110 can then transmit the images or video over network 150 to a remote server 130, a database 152, or both for processing. In some embodiments, image capture device 100A and / or client device 110 can perform at least one or more operations on one or more image frames from the images or video using processors 112-1 and / or 112-2 (collectively referred to hereinafter as “processor 112”), respectively, before transmitting the images to server 130 or database 152. For example, in some embodiments, client device 110 can perform at least one or more quality control steps on one or more images provided by image capture device 100A before transmitting them to server 130. In some embodiments, the client device 110 can obtain a preliminary or definitive diagnosis based on an analysis of an image of the test cartridge 101. Thus, in some embodiments, the client device 110 can transmit a preliminary or definitive diagnosis to the server 130, with or without an image of the test cartridge 101. To perform these operations, the processor 112 can execute instructions and collect or store data, where the instructions and data are stored in memory 132-1 (in the image capture device 100A) or in memory 132-2 (in the client device 110).

[0019]

[0037] Client device 110 communicates with image capture device 100A via signal 160-1 and with server 130 via signal 160-2 using communications module 118-2. For example, in some embodiments, signal 160-1 includes a transmittable file generated by processor 112-1 containing data from an array sensor collecting images from test cartridge 101, and signal 160-2 includes an assay diagnosis based on image analysis of the transmittable file. Image capture device 100A can communicate with client device 110 through communications module 118-1. Signals 160-1 and 160-2 (hereinafter collectively referred to as "signals 160") can be digital or analog signals, wireless signals, radio frequency (RF) signals, electrical signals, Ethernet signals, and the like. Communications modules 118-1 and 118-2 will hereinafter be collectively referred to as "communications modules 118." Communications module 118 may include an RF antenna and associated hardware and software for communication via Wi-Fi, Bluetooth (e.g., Bluetooth Low Energy (BLE)), or near field contact (NFC) protocols. For example, communications module 118 may include BLE or NFC protocols when image capture device 100A and client device 110 are in relative proximity to one another. Additionally, any of signals 160 may be encrypted and / or coded for security purposes.

[0020]

[0038] In some embodiments, image capture device 100A can include a sensor array 140 and an optics coupling mechanism 115 (e.g., a lens system with or without autofocus capabilities). In some embodiments, optics coupling mechanism 115 is a single lens. In some embodiments, optics coupling mechanism 115 can include diffractive, refractive, and reflective components such as mirrors, prisms, gratings, and the like. In some embodiments, optics coupling mechanism 115 can also include waveguide optical elements such as semiconductor waveguides, optical fibers, and the like. Sensor array 140 can collect one or more images of test cartridge 101 at a desired frame rate to form a video. In some embodiments, sensor array 140 can collect a single image of test cartridge 101 (e.g., after the assay has completed its process) or can collect multiple images (e.g., before and after the assay has completed its process). In further embodiments, sensor array 140 can collect multiple images of test cartridge 101 at a preselected frequency rate. The frequency rate may be adjusted, changed, accelerated, or slowed down based on preliminary or quality control tests being performed by the client device 110 .

[0021]

[0039] The remote server 130 can provide support for the image capture application 122 installed in the memory 132-2 of the client device 110. Support can include installing updates, acquiring raw data (e.g., photos, sequences of photos, and videos) for storage in the database 152, image processing, and the like. The image capture application 122 can include commands and instructions for controlling the image capture device 100A. The image capture application 122 can also include commands and instructions for performing at least a partial analysis of one or more images provided by the image capture device 100A. For example, in some embodiments, the instructions in the image capture application 122 can include a neural network (NN), artificial intelligence (AI), or machine learning (ML) algorithm to evaluate a diagnosis based on one or more images of the test cartridge 101. Additionally, in some embodiments, the image capture application 122 can include instructions for evaluating quality control of one or more images provided by the image capture device 100A based on sensor data indicating the positioning of the test cartridge 101 within the enclosure 120. The sensor data may be provided by sensors disposed within the enclosure 120 .

[0022]

[0040] In some embodiments, the client device 110 can further include an image capture device 100B for capturing an image of the fiducial label 105 on the test cartridge 101. Thus, the image capture application 122 can incorporate the image of the label 105 on the test cartridge 101 into a measurement protocol. The measurement protocol can be transmitted by the client device 110 to the server 130 and / or database 152, where metadata associated with the sampling cartridge 101 can be correlated with information stored therein. For example, in some embodiments, the metadata in the fiducial label 105 can be correlated with a user identifier (ID) and an assay identification code (e.g., influenza test, Lyme disease test, pregnancy test, hepatitis, or any other disease or assay). Hereinafter, image capture devices 100A and 100B will be collectively referred to as "image capture device 100."

[0023]

[0041] In some embodiments, the image capture application 122 may also include instructions for the user regarding the mode of use and measurement protocol of the test cartridge 101. For example, the instructions may guide the user step-by-step through how to collect a sample (e.g., using a swab or other extraction mechanism), mix the sample with appropriate reagents, and provide at least a portion of the sample within the test cartridge 101. Accordingly, the image capture application 122 may display instructions and other example icons to the user on the display 116 of the client device 110.

[0024]

[0042] FIG. 2 illustrates an enclosure 220 and other internal or external components within an image capture device 200, according to some embodiments. The enclosure 220 functions as a light-blocking element covering a circuit support board 223 disposed on an optical chassis 224 and a cartridge mount 226. In some embodiments, the image capture device 200 includes a light indicator 221 on top of the enclosure 220. The light indicator 221 provides user feedback related to the stages of the image capture device 200 and the progress of image collection. For example, in some embodiments, the light indicator 221 changes from one color to another and / or from a flashing state to a steady state to provide user feedback regarding the progress of an assay. In some embodiments, for example, the light indicator 221 includes a light-emitting diode (LED) that changes color and changes from a flashing state to a steady state to indicate the stages and progress of an assay. In some embodiments, the light indicator 221 can have three different colors and two patterns (e.g., steady and blinking). For example, the light indicator 221 can cycle through a blinking blue, a solid blue, a blinking red, a solid red, a blinking purple, and a solid purple to indicate a change in the state or stage of the instrument. In some embodiments, a blinking blue indicator light 221 can notify a user that the image capture device has been plugged in, a solid blue indicator light 221 can notify a user that the image capture device has been connected to a device, such as paired with a smartphone, a blinking red indicator light 221 can notify a user that the image capture device is ready to receive a test cartridge, a blinking purple indicator light 221 can notify a user that an assay is in progress, and a solid purple indicator light 221 can notify a user that an assay is complete and the results have been provided to the connected device.

[0025]

[0043] 2, cartridge mount 226 receives a test cartridge (e.g., test cartridge 101). Circuit support substrate 223 may include a sensor array disposed in the image plane of an optics coupling mechanism (e.g., optics coupling mechanism 115) mounted on optical chassis 224. The optics coupling mechanism can display an image of the test cartridge on the sensor array. Base member 228 can support enclosure 220 and cartridge mount 226. In some embodiments, spacer 230 can be disposed on base member 228 to support optical chassis 224 and, therefore, to adjust the distance between the optics coupling mechanism and the test cartridge in cartridge mount 226.

[0026]

[0044] 3A-3D show an optical chassis 324 and a cartridge mount 326 in an image capture device 300 according to some embodiments.

[0027]

[0045] 3A shows a base member 328 that supports an optical chassis 324 and a cartridge mount 326. Cartridge mount 326 can include a cam lever 323 that locks the test cartridge in place and closes a light shield on top of it to prevent any ambient light from disturbing the measurement.

[0028]

[0046] 3B-3D show different configurations of the optical chassis depending on the selected working distance for the optical setup. The working distance (WD) is the distance between the camera lens and the test cartridge being imaged. In some embodiments, it is desirable to have a relatively short working distance for a compact overall design of the enclosure (reduced form factor). In some embodiments, a trade-off occurs between a short working distance and a relatively small numerical aperture optical system that supports relatively small aberrations and relatively good image quality. It should be understood that FIGS. 3B-3D are merely example embodiments for illustrative purposes, and that other form factors and WDs are contemplated within the scope of the present disclosure.

[0029]

[0047] FIG. 3B shows the optical chassis including the cartridge mount configured for a working distance of 24.5 mm.

[0030]

[0048] FIG. 3C shows the optical chassis including the cartridge mount configured for a working distance of 29.5 mm.

[0031]

[0049] FIG. 3D shows the optical chassis including the cartridge mount configured for a working distance of 37.4 mm.

[0032]

[0050] 4A-4F show cross-sectional views of an enclosure 420, a cartridge mount 426, an optical chassis 424, and a sensor array 440 in image capture devices 400A, 400B, 400C, 400D, 400E, and 400F (collectively referred to hereinafter as "image capture device 400") according to some embodiments. While FIGS. 4A-4F show specific embodiments, it should be understood that different versions of the same components may be utilized for commercial evaluation kits or optimized for size and cost, as appropriate. Some of the components in image capture device 400 may be selected as follows:

[0033]

[0051] Sensor Array (Camera) - A complementary metal-oxide semiconductor (CMOS) color sensor (e.g., OmniVision part #: OV07676-H20A) can be selected to capture dark and bright images of the test cartridge. In some embodiments, the camera can be fitted with a lens and UV cutoff filter (580 nm to 650 nm) to ensure that only the appropriate emission wavelength light is detected.

[0034]

[0052] Light Source—One, two, or more UV LEDs (e.g., Lite-On Inc. part #: LTPL-C034UVH365(OG)) can be selected for uniform illumination of the test cartridge test window. In some embodiments, the UV LEDs can be operated with a current of approximately 500 mA to generate approximately 665 mW of optical power at a wavelength of approximately 365 nm. In some embodiments, the light source used to illuminate the test cartridge can include two opposing UV LEDs (e.g., for excitation of europium-based fluorescent compounds) aligned to provide uniform illumination across a defined imaging area within the test cartridge. In some embodiments, the light source includes a UV LED with an operating life of over 1000 hours. The following table provides various example test conditions. In the methods and measurement protocols disclosed herein, the effective operating time of the light source may be only a few seconds per test (since it may only be enabled during bright image capture). Therefore, operating conditions in realistic case scenarios may be much more relaxed than the test conditions in the table below. Assuming an extreme case where the UV LED is left in the on state for 10 seconds per test (e.g., 5 x the expected duration in a routine test), this equates to just 2 hours of UV LED on time over the desired life of the image capture device (approximately 2 seasons). Table 1 provides example UV LED life test data.

[0035] [Table 1]

[0036]

[0053] UV cutoff filters (one, two, or more, typically one for each light source) with a passband of approximately 450 nm to 650 nm are used to select the wavelength of light that excites the test cartridge (e.g., Schott Inc. Part #: UG1 FUG-112).

[0037]

[0054] The system-on-chip (SoC) is a single integrated circuit (IC) that can be selected as an embedded microprocessor (e.g., Nordic Semiconductor part #: nRF52840-QIAA) that includes a Bluetooth radio for the image capture device. In some embodiments, custom embedded software for operating the image capture device can reside within the SoC. The SoC can include a 32-bit embedded processor (e.g., an ARM® Cortex®-M4) with a 64 MHz clock and 1 MB of flash memory and 256 kB of random access memory (RAM). The SoC can include a Bluetooth radio with a 2.4 GHz transceiver with 103 dBm sensitivity and up to +8 dBm transmit power in accordance with IEEE 802.15.4-2006.

[0038]

[0055] Optical Chassis—In some embodiments, the optical chassis is a custom plastic part that determines the distance between the sensor array and the test cartridge in the Z direction (e.g., vertically). This distance can include the working distance between the test cartridge and the lens and the focal distance between the lens and the sensor array. Thus, the shape and dimensions of the optical chassis select the desired optical field of view (FOV) and desired illumination profile on the supported test cartridge. Furthermore, the optical chassis also defines the location and relative orientation of one or more light sources versus the region of interest (ROI) within the test cartridge.

[0039]

[0056] The light shield may be a custom plastic part that blocks any ambient light from entering the instrument once the test cartridge is inserted.

[0040]

[0057] Table 2 calculates mean time between failures (MTBF) for electronic components according to some embodiments.

[0041] [Table 2]

[0042]

[0058] The electronic component options are not intended to be limiting, but the above table illustrates that many different options may be sufficient to achieve the desired operating life of the image capture devices disclosed herein.

[0043]

[0059] 4A shows an enclosure 420 configured to block ambient light from entering a dark chamber in which a sensor array 440 and an optical chassis 424 are disposed. A cartridge mount 426 receives a test cartridge such that the test cartridge is disposed at least partially inside the dark chamber within the enclosure 420. A base member 428 receives and supports the cartridge mount 426, the optical chassis 424, and the enclosure 420.

[0044]

[0060] The optical chassis 426 includes a lens mount 407-1 and at least one light source mount 407-2 and 407-3 in predetermined positions relative to each other. In some embodiments, the sensor array 440 is positioned on the image plane of the lens 415 mounted in the lens mount 407-1. In some embodiments, the optical chassis 426 further includes at least one filter mount 407-4 for a filter 417 in the optical path between the cartridge mount and the lens mount. The lens mount 407-1, the light source mounts 407-2 and 407-3, and the filter mount 407-4 are hereinafter collectively referred to as the "optical mount 407." In some embodiments, the lens 415 may be a video camera lens or a smartphone lens.

[0045]

[0061] In some embodiments, image capture device 400A includes a memory circuit that stores instructions that, when executed by processor circuit 412, cause image capture device 400A to at least partially perform some of the steps of methods consistent with the present disclosure. In some embodiments, processor circuit 412 includes a light source controller configured to provide a signal to one or both of light sources 437-1 and 437-2 (collectively referred to herein as "light sources 437") when cartridge mount 426 receives a test cartridge inside the dark chamber formed by enclosure 420. Processor circuit 412 may also include a sensor array controller for activating at least one pixel in sensor array 440 when at least one of light sources 437 is in an "on" state. The sensor array controller in processor circuit 412 also receives a signal from at least one pixel indicative of the optical intensity of light emitted from the test cartridge (e.g., in response to illumination light provided by one of light sources 437).

[0046]

[0062] In some embodiments, processor 412 executes instructions to crop a selected area of ​​interest within the test cartridge and to generate a transmittable file containing an image of the area of ​​interest within the test cartridge. In some embodiments, processor 412 executes instructions to encode the transmittable file in a digital format according to a Bluetooth or Wi-Fi protocol. For example, in some embodiments, processor 412 executes instructions to encrypt the transmittable file according to a security protocol in one of BLE, Wi-Fi, or any other digital communication configuration. In some embodiments, processor 412 also provides instructions to an RF antenna to transmit the transmittable file to an external processor via the antenna.

[0047]

[0063] In some embodiments, lens mount 407-1 is positioned to define a fixed vertical distance 419 between lens 415 and a read zone on the test cartridge, a fixed vertical distance 410 between light source 437 and a read zone on the test cartridge, and a fixed horizontal distance 425 between light sources 437. In some embodiments, screw 427 or any other mechanical actuator can adjust distance 419 by acting on substrate 423. Substrate 423 can support processor circuitry 412, memory circuitry 432, and lens mount 407-4.

[0048]

[0064] In some embodiments, the optical mounts 407 are movable relative to one another to adjust the quality of the image of the test cartridge collected by the sensor array 440. In some embodiments, the processor circuit 412 also includes a processor for initiating at least one of the optical mounts 407 to adjust the relative position between the light source 437, the test cartridge, and the sensor array 440 when the signal from at least one pixel is below a predetermined value. Thus, in some embodiments, the processor circuit 412 can perform an autofocus operation and move the optical mounts 407 relative to one another to ensure that a sharp image of the test cartridge is collected in the sensor array 440. The autofocus operation can include adjusting the distance 419 between the lens 415 in the cartridge mount 426 and the test cartridge. In some embodiments, moving the optical mounts 407 relative to one another can include adjusting the angle 414 between two or more of the light sources 437.

[0049]

[0065] FIG. 4B shows a cutout of an enclosure in the image capture device 400B according to some embodiments. A presence sensor for detecting the presence of a test cartridge in the enclosure can include a mechanical switch that activates when a test cartridge is inserted. In some embodiments, the switch can include an arm (e.g., Omron Electronics Inc. part number #: SS-10GL13 or TE Connectivity part #: JJEV0UG380NOHPMRTR) that is pushed in the same horizontal axis as the test cartridge slides over it. In some embodiments, the switch can actuate in the vertical direction (Z-axis) and is depressed when a test cartridge slides over it. Selection of a particular presence sensor can reduce the overall diameter of the enclosure to a desirable size. In some embodiments, a USB-C compliant receptacle serves as the power entry for the image capture device 400B. Thus, in some embodiments, the image capture device 400B generates all voltages internally from a single 5V USB power input.

[0050]

[0066] Image capture device 400B also includes a digital temperature sensor (e.g., Texas Instruments part #: LMT01LPGM) for measuring the temperature within the optical chamber. In some embodiments, image capture device 400B can also include an LED driver for providing a constant current (e.g., about 60 mA to about 600 mA, or more) to each of the UV LEDs operating at 12 V direct current (dc) (e.g., MikroElektronika part #: MIKROE-3399) or 5 Vdc (e.g., Diodes Incorporated part #: AL5802-7).

[0051]

[0067] 4C shows a cross section of an enclosure for image capture device 400C according to some embodiments and the field of view within the enclosure. Image capture device 400C includes exterior dimensions of 2.3 inches (58.4 mm) in diameter by 3.2 inches (81.3 mm) in height. The receptacle slot is 0.18 inches by 0.80 inches (4.9 mm by 20.3 mm) to accommodate various commercially available FIA ​​test cartridges.

[0052]

[0068] 4D shows a perspective view of an enclosure within image capture device 400D, showing the cartridge mount, according to some embodiments. By positioning the LEDs along the longitudinal dimension of the test cartridge, as in image capture devices 400A, 400B, 400C, and 400D, shadowing artifacts near the sample area of ​​the test cartridge are avoided. In such embodiments, the optical chassis provides light sources at the proximal and distal ends of the test cartridge.

[0053]

[0069] FIG. 4E illustrates the configuration for different optical components within the enclosure of the image capture device 400E, according to some embodiments. The light shield shutter is activated by a cam lever when the test cartridge is fully inserted. It remains in an open state to allow the test cartridge to pass. In some embodiments, the lower printed circuit board (PCB) containing the SoC has a limit switch positioned to activate the lever when the cartridge is inserted into the receptacle slot. Within the image capture device 400E, the light source is positioned along the side of the test cartridge, and although shadowing phenomena may be considered, such a configuration can allow for a relatively compact design and relatively bright illumination of the test cartridge 401.

[0054]

[0070] 4F shows a perspective view of an optical chassis 424 and a cartridge mount 426 with a light shield 430 in an image capture device 400F according to some embodiments. Within the image capture device 400F, a light source is positioned along the side of the test cartridge. The test cartridge 401 is inserted into a cartridge mount 426 disposed on a base member 428. The light shield 430 is in an open position when the cartridge mount 426 is empty. The optical mount 407 supports a light source 437. An optical coupling mechanism 415 provides a partial image of the test cartridge 401 to a sensor array controlled by a processor circuit 412 executing instructions stored in a memory circuit 432.

[0055]

[0071] 5A-5B show top-down views of test cartridges 501A and 501B (collectively referred to herein as "test cartridges 501") within cartridge mounts 526 in base member 528 and the field of view 502 of image capture devices 500A and 500B (collectively referred to herein as "image capture devices 500"). In some embodiments, test cartridge 501 includes a read zone (e.g., read zone 522A or 522B, collectively referred to herein as "read zone 522") bounded by a boundary (e.g., 521A and 521B, collectively referred to herein as "boundary 521"). In some embodiments, read zone 522 is a portion of the sensing area of ​​test cartridge 501 having a dimension 510 within field of view 502.

[0056]

[0072] FIG. 5A shows a sample collection port 535A located in the middle of test cartridge 501A and two symmetrically positioned read zones 522A adjacent thereto.

[0057]

[0073] 5B shows sample collection port 535B at one end of test cartridge 501B and read zone 522B disposed on one side thereof. Hereinafter, collection ports 535A and 535B will be referred to as "collection ports 535."

[0058]

[0074] In some embodiments, image capture device 500 includes a memory circuit 532 and a processor circuit 512. Memory circuit 532 can store instructions that, when executed by processor circuit 512, cause image capture device 500 to apply a geometric transformation to the area bounded by boundary 521 to form an image of reading zone 522 of a selected size and shape. In some embodiments, processor circuit 512 executes instructions to identify a target region within reading zone 522 and to evaluate the quality of the image based on the size and dynamic range of the target region. Further, in some embodiments, processor circuit 512 executes instructions to adjust optical coupling within image capture device 500 when the quality of the image is below a selected threshold. In some embodiments, processor circuit 512 executes instructions to find boundary 521 and apply a geometric transformation to the area bounded by boundary 521. In some embodiments, when the quality of the image is above a selected threshold, processor circuit 512 determines a thematic diagnosis based on a digital analysis of the image. In some embodiments, the processor circuit 512 identifies the fiducial label 508 in the image collected from the test cartridge 501. In some embodiments, the processor circuit 512 identifies at least the test line 506t and the control line 506c in the read zone 522.

[0059]

[0075] 5C shows a top-down view of the cartridge mount without a test cartridge to illustrate the FOV of the optical coupling mechanism (e.g., camera lens) in the image capture device, according to some embodiments. While the specific dimensions are for illustrative purposes only, in some embodiments, it is desirable for the illumination area produced by the light source to exceed the FOV of the optical coupling mechanism to make the most of the sensor array.

[0060]

[0076] FIG. 6A shows a general layout of optical components according to some embodiments and a cross-sectional view of an illumination pattern formed on a test cartridge in an image capture device. The focal length (FL) defines the distance between the optics coupling mechanism (e.g., a lens) and the sensor array (e.g., a CMOS array or "camera") on the image plane of the optics coupling mechanism. The working distance (WD) defines the distance between the optics coupling mechanism and the object to be imaged (e.g., a monitoring area within the test cartridge). The FOV defines the area (e.g., a test window) that can be imaged by the optics coupling mechanism on the sensor array. In some embodiments, two light sources (e.g., UV LEDs, see above) illuminate the sensing area in opposite directions to provide bright, uniform illumination on the test window. The illumination light excites fluorescent emissions from target compounds captured within the sensing area of ​​the test cartridge. The fluorescent emissions are imaged onto the sensor array.

[0061]

[0077] 6B shows a cross-sectional view of an illumination pattern formed on test cartridge 601 by two light sources 637-1 and 637-2 (collectively referred to herein as "light sources 637") mounted on optical chassis 624 in image capture device 600B, according to some embodiments. Lens 615 is supported on lens mount 607-1, and light sources 637 are supported on light source mounts 607-2 and 607-3, respectively (collectively referred to herein as "optical mount 607"). Optical mount 607 is arranged such that light sources 637 direct illumination light 617-1 and 617-2, respectively (collectively referred to herein as "illumination light 617") to read zone 622 on test cartridge 601. In some embodiments, illumination light 617 is incident on read zone 622 at a predetermined angle 655 relative to an optical axis 651 defined by lens 615 in lens mount 607-1 in a plane that includes longitudinal direction 652 of test cartridge 601. Processor circuit 612 and memory circuit 632 are coupled to sensor array 640 as described above (see processor circuit 412 and memory circuit 432).

[0062]

[0078] In some embodiments, lens mount 607-1 is positioned to define a field of view 602 for lens 615. Field of view 602 can accommodate multiple read zones 622. In addition to other parameters, vertical distance 610 between light source 637 and read zone 622 and angle 614 between the optical axes of each of light sources 637-1 and 637-2 can increase or decrease field of view 602. Without limitation, in a configuration for image capture device 600B, test cartridge 601 includes read zones 622 separated by sample collection port 635 over horizontal distance 604.

[0063]

[0079] FIG. 6C shows a cross-sectional view of an illumination pattern formed by light source 637 on test cartridge 601 in image capture device 600C, including field of view 602, according to some embodiments. Devices 600B and 600C will hereinafter be collectively referred to as "device 600." Illumination pattern 602 includes read zone 622 within test cartridge 601 as it is inserted into cartridge mount 626. When test cartridge 601 is fully seated, door actuation lever 627 is activated and cam lever 633 is biased downward toward test cartridge 601. Cam lever 633 thus closes light shield 630 at the proximal end of test cartridge 601 and creates a light-tight enclosure within optical chassis 624. Optical coupling mechanism 615 provides a partial image of test cartridge 601 to a sensor controlled by processor circuit 612 executing instructions stored in memory circuit 632.

[0064]

[0080] 7A-7E illustrate different designs and models of test cartridges used in an image capture device, according to some embodiments. In some embodiments, the optical chassis can be designed to optimize performance for multiple commercially available test cartridges. The multiple commercially available test cartridges have the same or similar overall dimensions, but the test windows are located in various positions and have different sizes. Thus, the optical chassis is configured to provide an illumination area and FOV for the optics coupling mechanism to accommodate different types and sizes of test windows (sensing areas) for different test cartridge models. In addition, different test cartridge models have test windows in different locations within the test cartridge. The optical chassis also provides uniform illumination for the illumination area. Some of the supported test cartridge types include:

[0065]

[0081] Figure 7A shows that the optical chamber design is optimized to accommodate the region of interest (ROI) for various test cartridges, such as immunoassays sold under the trademarks SOFIA or SOFIA2 (Quidel Corporation). For example, any test cartridge having an ROI, shown by a relatively small rectangle encompassing the test window in Figure 7A, is contained within the field of view (FOV), shown by a relatively large rectangle in Figure 7A. In some embodiments, an FOV rectangle having dimensions of 34.5 mm x 25.9 mm can capture the ROI for a supported cassette.

[0066]

[0082] Figure 7A shows two configurations of test cartridges for the detection of analytes such as influenza A and / or B (test windows 19.5 x 5.0 mm and 17.5 x 12.2 mm, respectively), and on the right, a test cartridge for the detection of analytes such as antigens associated with Lyme disease (test window 34.5 x 9.8 mm).

[0067]

[0083] Figure 7B shows a diagram of the different elements of interest for image capture on the test cartridge, including the barcode area, the assay area, and the illumination area (41 x 19 mm). The proposed FOV may be approximately rectangular with dimensions of 38 x 15 mm.

[0068]

[0084] FIG. 7C shows a test cartridge for the detection of infectious specimens such as influenza A, B, or both.

[0069]

[0085] 7D shows a test cartridge in which the sample is collected in the center section and two different test assays are performed in opposite directions toward two different test windows, each reporting a different analyte component in the sample, including a control assay. In one embodiment, the test cartridge device is detecting, for example, IgG immunoglobulins.

[0070]

[0086] FIG. 7E shows a test cartridge containing 12 assay lines for detecting up to 12 different target analytes, including a control assay.

[0071]

[0087] 8A-8B illustrate a cartridge mount including a presence sensor in an image capture device according to some embodiments, including features such as support for multiple types of test cartridges, a test cartridge insertion detector, providing a consistent location in the XY direction for the sample window of a given test cartridge, and blocking ambient light from entering the instrument during image capture.

[0072]

[0088] FIG. 8A illustrates one embodiment of a cartridge mount configured to generate a consistent position for each inserted test cartridge. In some embodiments, the cartridge mount can receive test cartridges with the widest width available from multiple commercially available test cartridges. The cartridge mount may include a top guide bar with four corners that are molded into the receptacle guide path. These guides contact the upper outer side edges of the test cartridge, ensuring that the test cartridge rests flat against the centrally located lower inner surface. Thus, a user can insert a test cartridge until it stops against the rear wall located at the far end of the cartridge mount.

[0073]

[0089] The cartridge mount also includes a mechanical switch that is activated when the test cartridge is fully inserted to detect the presence of the test cartridge. Some embodiments may include a lever arm switch that is pushed along the same direction as the test cartridge's entry. In addition, an alternative solution is needed to meet the overall diameter requirements for the production version. In the final product design, a lever located within the bottom surface of the receptacle bends as the test cartridge is inserted into place, thereby activating the presence switch. This notifies the SoC that a test cartridge is present in the cartridge mount and allows the image capture device to activate, potentially after a defined time interval.

[0074]

[0090] In some embodiments, the cartridge mount incorporates a light shield to block ambient light. This may be desirable in embodiments configured to accept a bidirectional test cartridge with two separate fluid flow paths (e.g., for Lyme disease detection; see FIG. 7D). In some embodiments, the bidirectional test cartridge has a sample port located between two test areas on the top surface of the test cartridge. Thus, the test cartridge's sample port passes through the enclosure entrance, while all other sample port areas remain proximal to the enclosure entrance and maintain a nominal insertion height. Therefore, bidirectional test cartridges require a relatively high enclosure entrance to allow the sample port to pass through. Therefore, the light shield may be mechanically activated when the test cartridge is fully inserted using a simple cam lever, thereby preventing any ambient light interference through the raised enclosure entrance. The enclosure entrance is then lowered into contact with the top surface of the test cartridge, thereby blocking further height of the cartridge mount entrance and, in the process, also preventing ambient light leakage inside the dark chamber.

[0075]

[0091] FIG. 8B shows a cartridge mount that includes a small flexure that depresses the presence switch when a cassette is inserted, according to some embodiments. This configuration prevents the test cartridge from pushing back when the switch is activated along the entry direction. Additionally, there is a light shield with a flexure that depresses to block light when a test cartridge is inserted. The presence switch is cycled only once with every test cartridge insertion (e.g., once for every test). In some embodiments, there is a 10x safety factor, and the switch can be selected to cycle no more than approximately 7,200 times over the desired life of the image capture device. This is well within the ratings of available commercial switches (e.g., TE Connectivity part #: JJEV0UG380NOHPMRTR is rated for 100,000 cycles; see Table 3 below).

[0076] [Table 3]

[0077]

[0092] 9 is a perspective view of a cartridge mount 926 including a light shield 930, a leaf spring 923, and a door actuation lever 927 for receiving a test cartridge 901 within an enclosure of an image capture device (e.g., image capture devices 100A, 200, 300, 400, 500, 600, and 700) according to some embodiments. In some embodiments, a base member 928 is configured to receive a test cartridge 901 having a read zone 922. The light shield 930 is positioned on the base member 928. The light shield 930 includes a cam lever 933 that engages with the test cartridge 901 to move the light shield from a first position (e.g., "open") to a second position (e.g., "closed").

[0078]

[0093] In some embodiments, the base member 928 includes a sensor 945 for identifying and communicating receipt of the test cartridge. In some embodiments, the sensor 945 may include a contact sensor, such as a capacitive-sensing contact element or an electrical switch. In some embodiments, the sensor 945 may include an optical sensor, an inductive sensor, a magnetic sensor, and the like. The light shield 930 may include a pair of leaf springs 923 for holding the light shield 930 in a first position. In some embodiments, the base member 928 includes a groove 937 for receiving a U-shaped portion of each leaf spring 945 when the light shield 930 is in its second position (e.g., closed).

[0079]

[0094] 10 is a close-up perspective view of a test cartridge 1001 inserted into a cartridge mount 1026 of an image capture device, according to some embodiments. The cartridge mount 1026 includes a light shield 1030 configured to snap into place upon actuation of a cam lever 1033. The shield 1030 blocks any ambient light from illuminating the test cartridge 1001 when in place against a door actuation lever 1027. In some embodiments, a retainer flexure 1035 presses the test cartridge 1001 into place within the cartridge mount 1026. A cartridge guide 1037 allows for positioning of the test cartridge 1001 within the cartridge mount 1026.

[0080]

[0095] 11A-11C show system block diagrams of electronic components within an image capture device according to some embodiments. A user interacts with the image capture device, for example, through an application installed within a client device (see applications within client device 110 or smartphones and the like). Some of the associated electronic components include a sensor array and driver, one or more light sources and light source drivers, and an SoC, in addition to other power regulators, converters, adapters, and interconnects. Some embodiments include a temperature sensor and a test cartridge presence detector, as described above.

[0081]

[0096] In one embodiment, the image capture device is identified through a unique alphanumeric identifier or identification (ID), for example, corresponding to the last four characters of the SoC's BLE media access control (MAC) address. The image capture device is enabled and discoverable (e.g., by a smartphone or other client device running an application) upon connection of a USB-C compliant connector. This allows pairing of the image capture device with the smartphone or client device over a Bluetooth radio. Once the image capture device and client device are paired, the application can trigger and schedule a range of functions within the image capture device, including turning on / off the light source, adjusting sensor array performance characteristics (e.g., exposure, transferring images over BLE), temperature readings, and testing metadata.

[0082]

[0097] Upon full insertion of the test cartridge, the light shield mechanism operates to enclose the distal end of the test cartridge and prevent stray light from entering the optics chamber (see Figures 4A-4F). The test cartridge presence sensor is also triggered, signaling the start of the immunodiagnostic test timer for image capture.

[0083]

[0098] When triggered, in the absence of illumination, an image of one or more test windows in the test cartridge is captured and transferred as a dark image. After this transfer is complete, the test window will be uniformly illuminated using two UV LEDs, and the illuminated image (bright image) will be transferred. The dark image will be used to ensure that stray light is not entering the optical chamber. The bright image will be used to run quality control (QC) algorithms to ensure the test runs properly on a calibrated test cartridge without non-specific binding. In some embodiments, the image can be cropped before transfer to minimize file size and speed of transfer while still capturing important information for the assay. In some embodiments, some data analysis can be performed within the image capture device. In still other embodiments, the image capture device does not perform any substantial analysis before sending the image to the paired client device.

[0084]

[0099] In some embodiments, data analysis of the two images (dark / light) / test is performed by an application running within the client device. The dark image is analyzed for the presence of stray light, while the light image is continuously analyzed through a QC algorithm to ensure the image meets specific QC criteria. In some embodiments, an adjudication algorithm (e.g., machine learning, artificial intelligence, and the like) can be used to determine the status of the assay for each sample.

[0085]

[0100] 11C shows a functional block diagram of a sensor array driver according to some embodiments. In some embodiments, the sensor array includes a colored CMOS sensor (e.g., OmniVision OV7676, 1 / 7.5-inch VGA CMOS). Some relevant characteristics for selecting a sensor array may include the quality of the images produced, the detection limit (sensitivity) of the analyte in a typical immunodiagnostic assay in a standard commercial test cartridge, pricing at production scale, and the manufacturer's willingness to maintain the product line.

[0086]

[0101] The image sensor core generates streaming pixel data at a constant frame rate. The sensor driver samples each pixel analog value, converts it to a 10-bit digital value, and then streams it over a digital interface to the image sensor processor. Some configurations (e.g., for test, or quick runs, checkups, and the like) can use 8-bit digital conversion. Thus, pixel intensities range from 0 to 2 10 (or, in some configurations, 2 8 (It is).

[0087]

[0102] In some embodiments, the sensor array includes an image interface that supports multiple digital streaming formats. In addition, the image interface may include a two-wire interface (I 2 C). In some embodiments, the image interface uses a Digital Video Port (DVP) interface. In some embodiments, the image interface can use a Serial Port Interface (SPI), such as, for example, a Single Channel SPI or a Parallel (4-bit) SPI interface. The particular choice of image interface can depend on device compatibility, speed, accuracy, and other considerations.

[0088]

[0103] FIG. 12 shows a block diagram of an interface between an SoC and a sensor array in an image capture device, according to some embodiments. In some embodiments, the SoC may include a microprocessor configured to drive an RF antenna and a radio (e.g., a Bluetooth radio). Therefore, in addition to cost considerations, it is desirable for the SoC of choice (e.g., the Nordic nRF52840 SoC) to have built-in BLE 5.0 capabilities, which provide both maximum range and speed for data transfer to Bluetooth devices. The BLE 5.0 protocol also provides a superior level of security as well as programmable input / output (IO) that allows for direct interfacing with the sensor array.

[0089]

[0104] Some tradeoffs to consider may include RAM and computing power for processing images from the sensor array. Primary external interfaces to the SoC may include a camera data interface, a camera configuration interface, sensor-temperature and test cartridge presence, UV LED drivers (x1, x2, and similar), status LEDs (x1, x2, and similar), an RF antenna interface, processor-specific peripherals (input clock, programming pins, and debug port).

[0090]

[0105] The digital IO lines within the SoC can be configured for various functions, as follows: image transfer is framed by toggling the VSYNC line, with each toggle indicating a new frame; the horizontal refresh (HREF) line marks the presence of valid row data; pixels are sent in groups of 640, i.e., one row at a time, within each HREF pulse; and image data is sent over 8 GPIO data lines, sending one pixel's worth of data in parallel per pixel clock (PCLK) cycle for every pixel in a given frame. In some embodiments, the pixel clock is configured for 2.5 MHz, and data is captured at this rate. In some embodiments, the rate of image capture and transmission through the SoC must be appropriately controlled to provide a frame.

[0091]

[0106] In some embodiments, the sensor array may include a sensor array for configuring settings such as exposure. 2 C protocol can be used. Therefore, I 2 One wire for the C clock and one for the I 2 A single wire for I / O data connects the SoC to the sensor array. The SoC's two-wire interface (TWI) peripherals are 2 C protocol and is used to configure the sensor array. The clock (SCL) and data lines (SDA) are tied together as shown.

[0092]

[0107] 13A-13B show block diagrams of a power distribution unit in an image capture device according to some embodiments. In some embodiments, the power distribution unit is designed to be powered via any standard commercially available USB power adapter.

[0093]

[0108] 13A shows one embodiment configured to receive a 12V supply to meet the power requirements of a commercially available development board. The SoC board and sensor array board each have their own internal power supplies to generate the required voltages, as shown.

[0094]

[0109] FIG. 13B shows a Power Distribution Unit without redundant power that allows operation with 5V input from a USB port. Additionally, the system can be optimized to maintain maximum power consumption below the recommended USB power limit with a relatively low power consumption. The system guarantees a maximum power of less than 2.5W (5V at 500mA) with a half target to ensure margin. In some embodiments, a newer generation USB adapter offering more power can be used, if desired. In the particular Power Distribution Unit shown, a 5V input is used to generate 1.8Vdc for the processor and image sensor digital logic, 2.8Vdc (analog voltage) for the sensor array, and a constant 60mA for the UV LEDs when the illumination is enabled.

[0095]

[0110] The maximum calculated power consumption of the illustrated unit is less than approximately 1.1 W. Table 4 below shows an example power budget for the system shown in Figures 11A-11C. The typical consumption is during an idle state - when the image capture device is waiting to capture an image and providing status over BLE. The maximum current case is during bright image capture when the light source is enabled and an image is being captured.

[0096] [Table 4]

[0097]

[0111] Figure 14 shows a timing diagram including signal and power waveforms within an image capture device, according to some embodiments. The image interface of the sensor array (e.g., a DVP interface, see Figure 11C) has a defined set of control lines, data lines, and timing to capture image data. The timing diagram provides the timing of VSYNC, HREF, and data relative to the pixel clock period (see example IO pin configuration above).

[0098]

[0112] Figure 15 shows a temperature sensor circuit diagram and key waveforms for driving the temperature sensor according to some embodiments. In some embodiments, the temperature sensor is a one-wire digital interface to the SoC. The temperature sensor may be powered via a 5V input and outputs a pulse train every 104 milliseconds (maximum, see Figures 13A-13B and 14). The processor counts the pulses to determine the temperature. A resistor (R2) on the output of the sensor sets the output voltage level. An approximately 13 kΩ resistor sets the output level at a voltage compatible with the SoC logic voltage (e.g., logic high = 13 kΩ x 125 μA = 1.625 V, logic low = 13 kΩ x 34 μA = 0.44 V).

[0099]

[0113] FIG. 16 shows a driver circuit for a light source in an image capture device according to some embodiments (see FIGS. 11A and 11B). In some embodiments, the light source driver is enabled via a control line to the SoC. In some embodiments, the light source can be controlled at a constant 60 mA current via the driver IC when enabled by the SoC. The light source current is set through R9, such as at Current=0.7V (internal reference) / R9 (e.g., an external resistor such as 11.5Ω).

[0100]

[0114] 17A-17B show radio block diagrams within an antenna interface and image capture device according to some embodiments.

[0101]

[0115] 17A illustrates a wireless antenna interface according to some embodiments. In some embodiments, the SoC includes a built-in 2.4 GHz transceiver compatible with multiple wireless standards (e.g., BLE 5.0). This radio block handles all conversion to and from the RF antenna and presents data through a standard internal memory interface. In some embodiments, the radio circuitry may be included within the SoC, and the RF antenna may be located external to the SoC.

[0102]

[0116] 17B shows a schematic diagram of RF components coupling an external antenna to a BLE radio terminal in an SoC according to some embodiments. RF inductor values ​​and capacitors are adjusted accordingly to obtain the desired fidelity, accuracy, and compatibility with the specifications of the selected SoC.

[0103]

[0117] 18 illustrates a mask 1800 having multiple portions 1810A, 1810B, 1810-1, 1810-2, 1810-3, and 1810-4 (collectively referred to as "mask portions 1810") used to filter light received by a sensor array 1840 in an image capture device according to some embodiments. The sensor array 1840 includes multiple light-sensing pixels 1821. In some embodiments, the image capture device can further include the mask 1800 positioned between a lens mount (e.g., lens mount 407-1 or 607-1) and the sensor array 1840. In some embodiments, the filter mask 1800 allows selected wavelengths of light to access selected ones of the multiple pixels 1821. In some embodiments, the sensor array 1840 can include complementary metal-oxide semiconductor (CMOS) circuitry. Furthermore, in some embodiments, the sensor array 1840 can include single color pixels or multi-color pixels, such as, for example, red, green, blue, RGB, pixels.

[0104]

[0118] In some embodiments, mask 1800 is disposed adjacent to sensor array 1840 and includes one or more dielectric material layers to transmit light of desired wavelengths to light-sensing pixels 1821 in sensor array 1840. Each mask portion 1810 is adjacent to one or more light-sensing pixels 1821, and each mask portion 1810 transmits light within a preselected wavelength range of the electromagnetic spectrum. In some embodiments, mask 1800 is disposed over sensor array 1840 such that a portion of an image of a sensing area in test cartridge 1801 overlaps at least one of mask portions 1810.

[0105]

[0119] Thus, the preselected wavelength region of the electromagnetic spectrum transmitted by mask portion 1810 is selected based on a portion of the image of the sensing area in test cartridge 1801. In some embodiments, the portion of the image of the sensing area in test cartridge 1801 includes a reagent sensitive to one of multiple analytes of interest in a test sample provided through sample port 1835, and the preselected wavelength region includes at least a portion of the emission spectrum of an emitter associated with the reagent. For example, the portion of the image of the sensing area in test cartridge 1801 includes a reagent sensitive to one of multiple analytes of interest in a test sample provided through sample port 1835, and the preselected wavelength region includes at least a portion of the emission spectrum of an emitter associated with the reagent. i λ ... i In some embodiments, one or more of the detection channels 1850 may be associated with a test line, and one or more of the detection channels 1850 may be associated with a control line (e.g., test line 506t and control line 506c).

[0106]

[0120] In some embodiments, at least one of the mask portions 1810 blocks light within a selected wavelength region of the electromagnetic wavelength range from reaching the light-sensing pixels 1821. In some embodiments, the mask portions 1810 are selected to allow the sensor array 1840 to independently detect signals from any one of multiple analytes of interest within the test cartridge 1801.

[0107]

[0121] In some embodiments, the sensor array 1840 is coupled to the memory circuit 1832 and the processor circuit 1812. Thus, the memory circuit 1832 can store instructions that, when executed by the processor circuit 1812, cause the sensor array 1840 to select a first group of pixels 1821 to form a first signal and a second group of pixels 1821 to form a second signal. For example, the first group of pixels can overlap with the first mask portion 1810-1, and the second group of pixels can overlap with the second mask portion 1810-2. Thus, the first signal can be associated with light in a first wavelength range from a first analyte of interest in the sample, and the second signal can be associated with light in a second wavelength range from a second analyte of interest in the sample.

[0108]

[0122] In some embodiments, the spectral transmittance of each mask portion 1810 is selected according to increased selectivity and discrimination between the different fluorescence emission bands of at least two or more reagents used in a lateral flow immunoassay.

[0109]

[0123] 19 is a flowchart illustrating steps of a method 1900 for determining the presence or absence of an analyte of interest according to some embodiments. Methods consistent with the present disclosure may include at least one or more of the steps of method 1900 performed at least in part by one or more devices in an architecture including a remote server, database, client device, and image capture device disclosed herein (e.g., architecture 10, remote server 130, database 152, client device 110, and image capture device 100). Any one of the server, database, client device, and image capture device may include memory circuitry for storing instructions and processor circuitry (e.g., memory circuits 132, 432, 532, 632, 732, and 1832, and processor circuits 112, 412, 512, 612, 712, and 1812) configured to execute the instructions to at least in part perform one or more of the steps of method 1900. In some embodiments, at least one or all of the server, database, client device, or image capture device can include a communications module configured to send and receive data to one or more of the devices in the architecture over a network or via a one-to-one (wired or wireless) communications channel (e.g., communications module 118 and network 150). The image capture device can include an enclosure and cartridge mount that encloses an optical assembly (e.g., enclosures 120, 220, and 420; optical chassis 224, 324, 424, 624, and 724; and cartridge mounts 226, 336, 426, 526, 726, 926, and 1026). The cartridge mount can be configured to receive a test cartridge, and the optical assembly can include a lens mount and at least one light source mount that is movable relative to one another (e.g., test cartridges 101, 501, 601, 801, 901, and 1001; and optical mounts 407 and 607).The light source mount can support a light source configured to illuminate the test cartridge (e.g., light sources 437, 637, and 737). The lens mount can support a lens configured to project an image of the illuminated test cartridge onto a sensor array disposed in the optical assembly. The image of the illuminated test cartridge can include at least a portion of a read zone within the test cartridge bounded by a boundary line.

[0110]

[0124] In some embodiments, a method consistent with the present disclosure may include at least one step from method 1900 or multiple steps from method 1900 that are performed in a different order or that overlap in time. For example, some embodiments consistent with the present disclosure may include one or more steps in method 1900 that are performed simultaneously or quasi-simultaneously.

[0111]

[0125] Step 1902 includes providing an image capture device including an enclosure that shields the cartridge mount and an optical chassis that includes at least a lens and a sensor array for collecting an image of a read zone within the test cartridge.

[0112]

[0126] In some embodiments, step 1902 includes calibrating an image capture device. In some embodiments, step 1902 can include adjusting the focus of a camera. In some embodiments, step 1902 can include calibrating a temperature sensor.

[0113]

[0127] Step 1904 includes placing a biological sample on a test cartridge containing an immunoassay for detection of one or more analytes of interest in the sample. In some embodiments, the sample is a biological sample such as a bodily fluid (e.g., blood, serum, plasma, sputum, nasal secretions, saliva, tears, or urine). In some embodiments, the bodily fluid may be of human origin. In some embodiments, the immunoassay includes reagents for the detection of an infectious agent (e.g., a virus or bacteria). In some embodiments, the immunoassay includes reagents for the detection of one or more protein biomarkers or autoantibodies. In some embodiments, the immunoassay is configured for the detection of 2-20 or more analytes of interest. In some embodiments, step 1904 includes flowing the biological sample over multiple test channels for the detection of 2-20 analytes of interest.

[0114]

[0128] Step 1906 involves inserting the test cartridge into the device.

[0115]

[0129] Step 1908 includes capturing an image of a read zone on the test cartridge having a sensor array.

[0116]

[0130] Step 1910 includes providing the image to an image processing circuit to determine the presence or absence of one or more analytes of interest. In some embodiments, step 1910 further includes detecting a unique signal emission associated with each of the analytes of interest in the sample.

[0117]

[0131] Immunoassay test strips, such as those in test cartridge 101, described above, can be uniquely configured for the detection of specific pathogens or analytes of a species of interest. These include, without limitation, proteins, haptens, immunoglobulins, enzymes, hormones, polynucleotides, steroids, lipoproteins, drugs, bacterial antigens, and viral antigens. In the context of bacterial and viral antigens, more commonly referred to in the art as infectious antigens, analytes of interest include Streptococcus, influenza A, influenza B, respiratory syncytial virus (RSV), hepatitis A, B, and / or C, pneumococcal, human metapneumovirus, coronaviruses (e.g., SARS-CoV-2), and other infectious agents known to those skilled in the art. Test assays detecting one or more analytes of interest are contemplated. In some embodiments, the test device is intended for the detection of one or more antigens associated with Lyme disease. In some embodiments, the immunoassay test strips are intended for use in the field of women's health. In other embodiments, test devices are contemplated for the detection of one or more of fetal fibronectin, chlamydia, human chorionic gonadotropin (hCG), hyperglycosylated chorionic gonadotropin, human papillomavirus (HPV), and the like. In another embodiment, immunoassay test strips are contemplated for the detection of vitamin D. Test strips for the detection of diseases or cardiac conditions are also contemplated.

[0118]

[0132] An exemplary immunoassay test strip can include a sample-receiving zone in fluid communication with a label zone. A fluid sample disposed above or within the sample zone flows downstream by capillary action from the sample zone. The label zone is in fluid communication with at least a test line or band, and optionally, a control line or band and / or a reference line or band. Typically, the label zone is located downstream from the sample zone, and a series of control and test lines are located downstream from the label zone, and an optional absorbent pad is located downstream of the portion of the test strip above which the lines are positioned.

[0119]

[0133] The sample zone receives a sample suspected of containing an analyte of interest. The label zone, in some embodiments, includes two dried complexes composed of particles containing label elements. The label elements include labels that emit signals in any of several selected emission processes, such as, for example, electromagnetic radiation, alpha particle emission, positron emission, beta emission, and the like. In some embodiments, the electromagnetic radiation emission can include fluorescence emission, Raman emission, and the like. Furthermore, in some embodiments, the labels can absorb selected types of radiation, such as electromagnetic radiation, for example, in microwave absorption, infrared (IR) absorption, visible absorption, or ultraviolet (UV) absorption. Furthermore, in some embodiments, the label elements can include multiple label elements selected from all or more of the above-mentioned radiation emissions and / or absorptions.

[0120]

[0134] Without loss of generality and to briefly illustrate the operation of the system, in one embodiment, the label element can include a fluorescent compound of an element. An exemplary fluorescent element is a lanthanide material, such as one of the 16 elements: lanthanum, cerium, praseodymium, neodymium, promethium, samarium, europium, gadolinium, thulium, terbium, dysprosium, holmium, erbium, ytterbium, lutetium, and yttrium. The choice of lanthanide material can include fluorescent emissions of specific colors. In some embodiments, multiple lanthanide materials with different color emissions can be used to enable signal multiplexing with a sensor array having colored pixels (e.g., red, blue, and green pixel arrays). For example, europium can be used for the red channel, while other lanthanides can be selected for green and blue emissions. In one embodiment, the lanthanide material is embedded within or on particles, such as polystyrene particles. In some embodiments, different organic fluorescent dyes (e.g., Alexa Fluor, cyanine, and the like) can be used to multiplex color and signal channels within the sample zone. The particles can be luminescent or fluorescent lanthanide-containing microparticles (particles less than about 1000 micrometers in diameter, in some instances less than about 500 micrometers in diameter, and in some instances less than 200, 150, or 100 micrometers in diameter), where in some embodiments the lanthanide is europium. In some embodiments, the lanthanide is chelated europium. In some embodiments, the microparticles have a core of a lanthanide material with a polymer coating, such as a europium core with a polystyrene coating. Binding partners for one or more analytes of interest in the sample are attached to or associated with the outer surface of the microfluidic device. In some embodiments, the binding partner for one or more analytes of interest is an antibody, a monoclonal antibody, or a polyclonal antibody.Those skilled in the art will appreciate that other binding partners can be selected and may include conjugates such as biotin and streptavidin conjugates. Upon entering the label zone, the liquid sample hydrates, suspends, and displaces the dried microparticle-antibody conjugates, carrying the conjugates along with the sample downstream on the test strip to control or reference and / or test lines disposed on an immunoassay test strip. The analyte of interest, if present in the sample, will bind to its respective conjugate as the specimen and microparticles flow from the label zone.

[0121]

[0135] As the sample and microparticle-antibody complexes continue to flow downstream on the immunoassay test strip, if the analyte of interest is present in the sample, the fluorescent microparticle-antibody complexes, now bound to the antigen / analyte of interest, will bind to the specific binding elements for the analyte of interest immobilized in one or more test lines. In some embodiments, a single test line is present on the test strip. In some embodiments, at least two or more test lines are present on the strip. By way of example, a test strip intended for the detection and / or differentiation of influenza A and influenza B may include a first test line for detecting influenza A and a second test line for detecting influenza B. Microparticle-antibody complexes comprising microparticles coated with antibodies specific for influenza A and microparticles coated with antibodies specific for influenza B may be included in the label zone and, in some embodiments, downstream of the negative control line. A first test line for influenza A and a second test line for influenza B may be disposed downstream of the label zone. The first test line for influenza A contains monoclonal or polyclonal antibodies to determinants on the nucleoprotein of influenza A, and the second test line for influenza B contains monoclonal or polyclonal antibodies to determinants on the nucleoprotein of influenza B. If antigen is present in the sample, a conventional immunoassay interceptor will form on each test line matching the antigen in the sample.

[0122]

[0136] Microparticle-antibody complexes that do not bind to the negative control line or the test line continue to flow downstream by capillary action, and the remaining sample encounters the reference line and, in some embodiments, thereby proceeds into the absorbent pad.

[0123]

[0137] The immunoassay test device is intended to receive a variety of samples, including, but not limited to, biological samples from human bodily fluids, including nasal secretions, nasopharyngeal secretions, saliva, mucus, urine, vaginal secretions, fecal samples, blood, and the like.

[0124]

[0138] In some embodiments, the kits described herein are provided with a positive control swab or sample. In some embodiments, a negative control swab or sample is provided. For assays requiring external positive and / or negative controls, the user can be instructed to insert or apply the positive or negative control sample or swab.

[0125]

[0139] Immunoassay bands emit fluorescent light primarily from fluorescent light bound to target analytes because they are immobilized on a substrate by adhesion (e.g., absorption, chemisorption, immuno-ligands, and the like) to immune proteins in the immunoassay strip. Therefore, the presence of red emission within the band boundaries can be attributed mostly to the presence of target analytes (e.g., the presence of pathogenic antigens and the like). However, the amount of red signal within the boundaries of an immunoassay band may include some background. To better assess the background signal (e.g., not from target analytes bound to antibodies on the bands), some sample cartridges include a blank control area.

[0126]

[0140] The phrase "at least one of," used herein with the word "and" or "or" to separate any of the items, preceding a series of items modifies the list as a whole and not each member of the list (e.g., each item). The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any of the items and / or at least one of any combination of the items and / or at least one of each of the items. By way of example, the phrases "at least one of A, B, and C" or "at least one of A, B, or C" mean A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0127]

[0141] To the extent that the terms "include," "have," or the like are used in the description or claims, such terms are intended to be inclusive in a manner similar to the word "include," as "include" is interpreted when used as a transitional term in the claims. The term "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0128]

[0142] Reference to an element in the singular is not intended to mean "one and only one," unless specifically stated otherwise, but rather "one and more." Structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject art. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly set forth in the preceding description.

[0129]

[0143] While this specification contains many details, these should not be construed as limitations on the scope of what may be claimed, but rather as descriptions of particular implementations of the subject matter. Also, certain features that are described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, while features may be described above as functioning in a particular combination, and in some cases may even be initially claimed as such, one or more features from a claimed combination can, in some cases, be deleted from the combination, and the claimed combination may be directed to subcombinations or variations of subcombinations.

[0130]

[0144] Although the subject matter herein has been described in terms of particular aspects, other aspects may be implemented and are within the scope of the appended claims. For example, although actions may be depicted in the figures in a particular order, this should not be understood as requiring that such actions be performed in the particular order or sequence depicted, or that all of the depicted actions be performed, to achieve desirable results. Actions described in the claims can be performed in a different order and still achieve desirable results. As an example, the processes depicted in the accompanying figures do not necessarily require the particular order or sequential order depicted to achieve desirable results. In certain situations, multitasking and parallel processing may be advantageous. Furthermore, the separation of various system components in the above-described aspects should not be understood as requiring such separation in all aspects, and it should be understood that the described program components and systems generally can be integrated together in a single software product or packaged in multiple software products. Other variations are within the scope of the appended claims.

[0131]

[0145] In one aspect, a method may be an operation, an instruction, or a function, and vice versa. In one aspect, a claim may be amended to include some or all of one or more other claims, one or more terms, one or more sentences, one or more phrases, one or more paragraphs, and / or terms (e.g., instructions, operations, functions, or components) recited in one or more claims.

[0132]

[0146] To illustrate the interchangeability of hardware and software, various illustrative blocks, modules, components, methods, operations, instructions, algorithms, etc., have been described generally in terms of their functionality. Whether such functionality is implemented as hardware, software, or a combination of hardware and software depends on the particular application and design constraints imposed on the overall system. Those skilled in the art may implement the described functionality in varying ways for each particular application.

[0133]

[0147] Phrases such as "one aspect," "that aspect," "another aspect," "some aspects," "one or more aspects," "one implementation," "that implementation," "another implementation," "some implementations," "one or more implementations," "one embodiment," "that embodiment," "another embodiment," "some embodiments," "one or more implementations," "one configuration," "that configuration," "another configuration," "some configurations," "one or more configurations," the subject technology, the disclosure, the present disclosure, other variations thereof, and the like are used for convenience and do not imply that disclosure associated with such one or more phrases is essential to the subject technology or that such disclosure applies to all configurations of the subject technology. Disclosure associated with one or more such phrases may apply to all configurations or one or more configurations. Disclosure associated with such one or more phrases may provide one or more examples. Phrases such as "one or more aspects" can mean one or more aspects, and vice versa, and this likewise applies to the other above-mentioned phrases.

[0134]

[0148] Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her or its), and vice versa. The term "some" means one or more. Underlined and / or italicized headings and subheadings are used for convenience only and do not limit the subject art and should not be referenced in connection with interpreting the description of the subject art. Relational terms such as first and second and the like may be used to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the subject art. No claim element is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for."

Claims

1. 1. A method for determining the presence or absence of an analyte of interest, comprising: receiving, within the client device, a wireless signal from the image capture device when a test cartridge is inserted within an enclosure of the image capture device, the test cartridge being loaded with a sample; identifying the image capture device through a unique ID provided through the wireless signal; pairing the image capture device with the client device; triggering a plurality of functions within the image capture device according to a schedule, the plurality of functions including turning "on" a light source within the image capture device and synchronizing the light source with a sensor array to collect dark and bright images of the test cartridge; receiving a data stream from the image capture device, the data stream comprising the bright image of the test cartridge; determining the presence of a target analyte in the sample based on the data stream and the bright image; A method having the following.

2. 10. The method of claim 1, wherein triggering a plurality of functions within the image capture device further comprises adjusting operational settings in a sensor array within the image capture device, the operational settings comprising one of an exposure time or a data transfer format.

3. 10. The method of claim 1, further comprising receiving a temperature value from the image capture device of a temperature inside an enclosure holding the test cartridge within the image capture device, and adjusting sample evaluation based on the bright image and the temperature value.

4. 10. The method of claim 1, wherein receiving the data stream comprises receiving test metadata from the image capture device, the test metadata comprising information in a fiducial label of the test cartridge.

5. The method of claim 1 , further comprising providing power to the image capture device via a universal serial bus coupled to the client device.

6. The method of claim 1 , further comprising receiving a second image in the data stream and assessing a quality of the measurement based on a comparison of the bright image and the second image.

7. 1. A method for capturing an image of a lateral flow assay from a sample in a test cartridge, comprising: receiving a signal from a presence sensor indicating the presence of the test cartridge within the enclosure; providing a wireless signal to a client device requesting initiation of a measurement to identify the presence of a target analyte in the sample, the wireless signal having a unique ID; activating a light shield to enclose the distal end of the test cartridge when the client device recognizes the unique ID and triggers the start of the measurement; collecting a first image of the test cartridge from a sensor array; determining a quality of the measurement based on the first image; providing a data stream having a first image of the test cartridge to the client device when the quality of the measurement is above a selected threshold; A method having the following.

8. 8. The method of claim 7, further comprising, upon receiving a trigger signal from the client device, turning a light source "on" to illuminate the test cartridge for a selected period of time, and transmitting a bright image to the client device, the bright image being collected from the sensor array while the light source was on.

9. 8. The method of claim 7, wherein acquiring the first image comprises acquiring the image of the test cartridge while a light source is turned "off."

10. The method of claim 7 , further comprising cropping the first image to capture selected information from the lateral flow assay.

11. A method for determining the presence or absence of an analyte of interest, comprising: receiving, within the client device, a wireless signal from the image capture device when a test cartridge is inserted within an enclosure of the image capture device, the test cartridge being loaded with a sample; identifying the image capture device through a unique ID provided through the wireless signal; pairing the image capture device with the client device; triggering a plurality of functions within the image capture device according to a schedule, the plurality of functions including turning "on" a light source within the image capture device; receiving a data stream from the image capture device, the data stream having a first image of the test cartridge; adjusting the first image of the test cartridge to improve image quality and reduce the size of the data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge; and determining the presence of a target analyte in the sample based on the first image of the test cartridge; receiving a temperature value from the image capture device for a temperature inside an enclosure holding the test cartridge within the image capture device; and adjusting a performance characteristic of a sensor array within the image capture device; A method having the following.

12. The method of claim 11, wherein triggering multiple functions within the image capture device further comprises adjusting operating settings in a sensor array within the image capture device, the operating settings comprising one of an exposure time or a data transfer format.

13. A method for capturing an image of a lateral flow assay from a sample in a test cartridge, comprising: receiving a signal from a presence sensor indicating the presence of the test cartridge within the enclosure; providing a wireless signal to a client device requesting initiation of a measurement to identify the presence of a target analyte in the sample, the wireless signal having a unique ID; activating a light shield to enclose a distal end of the test cartridge in response to inserting the test cartridge into the enclosure and triggering the initiation of the measurement; collecting a first image of the test cartridge from a sensor array; determining a quality of the measurement based on the first image; adjusting the first image of the test cartridge to improve image quality and reduce the size of a data stream, wherein adjusting the first image of the test cartridge comprises cropping the first image of the test cartridge; and providing, to the client device, the data stream having a thematic diagnosis based on digital analysis of the image when the quality of the measurement is above a selected threshold; A method having the following.

14. The method of claim 13, further comprising turning a light source "on" to illuminate the test cartridge for a selected period of time upon receiving a trigger signal from the client device, and transmitting a bright image to the client device, the bright image being collected from the sensor array when the light source is on.

15. The method of claim 13, wherein collecting the first image comprises collecting the image of the test cartridge while a light source is turned "off."

16. The method of claim 13, further comprising cropping the first image to capture a selected area of ​​interest from the lateral flow assay.

Images