Patent Application
20230057531
Some embodiments of the present disclosure are directed to systems and methods for conducting remote health testing and diagnostics. In particular, some embodiments of the present disclosure are directed to mobile device stands for use with remote health testing and diagnostics.
Use of telehealth to deliver health care services has grown consistently over the last several decades and has experienced very rapid growth in the last several years. Telehealth can include the distribution of health-related services and information via electronic information and telecommunication technologies. Telehealth can allow for long-distance patient and health provider contact, care, advice, reminders, education, intervention, monitoring, and remote admissions. Often, telehealth can involve the use of a user or patient's personal device, such as a smartphone, tablet, laptop, personal computer, or other type of personal device. For example, the user or patient can interact with a remotely located medical care provider using live video and/or audio through the personal device.
Remote or at-home health care testing and diagnostics can solve or alleviate some problems associated with in-person testing. For example, health insurance may not be required, travel to a testing site is avoided, and tests can be completed at a patient's convenience. However, at-home testing introduces various additional logistical and technical issues, such as guaranteeing timely test delivery to a patient's home, providing test delivery from a patient to an appropriate lab, ensuring test verification and integrity, providing test result reporting to appropriate authorities and medical providers, and connecting patients with medical providers, who are needed to provide guidance and/or oversight of the testing procedures remotely.
Health testing and diagnostics platforms are provided herein that can facilitate proctored or video-based at-home or remote healthcare testing and diagnostics. For example, users performing at home testing may be guided or assisted by proctors that are available over a communication network using, for example, live video on via the users' devices.
User devices can provide an important tool for enabling affordable remote and at-home healthcare. The user experience of remote or at-home healthcare can depend on how the user device is used, physically and digitally. For example, the physical side of this can include how the device is positioned and how the user interacts with it. Device stands can be used, which can, in some examples, be integrated into the product, to provide the proper positioning of the user device. In some embodiments, systems and methods herein may help to ensure adequate image quality. This can lead to improved accuracy of test results, a more pleasant user experience, and other benefits.
In some aspects, the techniques described herein relate to a method for remote diagnostic testing including: receiving, by a computer system from a user device, a first image frame; determining, by the computer system, a first area of the first image frame; identifying, by the computer system, a first feature in the first area; and providing, by the computer system to a user via the user device, an indication that the first feature is in the first area of the first image frame; and continuing, by the computer system, a remote diagnostic testing session.
In some aspects, the techniques described herein relate to a method, further including: receiving, by the computer system from the user device, a second image frame; identifying, by the computer system, a second area of the second image frame; determining, by the computer system, that the first feature is not within the second area of the second image frame; providing, by the computer system to the user via the user device, an indication that the first feature is not in the second area of the second image frame; and pausing, by the computer system, the remote diagnostic testing session.
In some aspects, the techniques described herein relate to a method, further including: receiving, by the computer system form the user device, a third image frame; identifying, by the computer system, a third area of the third image frame; determining, by the computer system, that the first feature is within the third area of the third image frame; providing, by the computer system to the user via the user device, an indication that the first feature is within the third area of the third image frame; and resuming, by the computer system, the remote diagnostic testing session.
In some aspects, the techniques described herein relate to a method, wherein the second area is the same as the first area and the third area is the same as the second area.
In some aspects, the techniques described herein relate to a method, wherein the first feature includes a test kit, a swab, a test strip, a reagent bottle, or a reference card.
In some aspects, the techniques described herein relate to a method, wherein the first feature includes a reference card.
In some aspects, the techniques described herein relate to a method, wherein the reference card includes a unique identifier of a test.
In some aspects, the techniques described herein relate to a method, further including: detecting, by the computer system, one or more fiducials in the first image frame; and adjusting an alignment of the first image frame, wherein adjusted the alignment includes adjust one or more of skew and keystone.
In some aspects, the techniques described herein relate to a method, further including: identifying, by the computer system, a detection threshold calibration area; determining, by the computer system, a first color of a first region of the detection threshold calibration area; determining, by the computer system, a second color of a second region of the detection threshold calibration area; determining, by the computer system, if a difference between the first color and the second color is greater than or equal to a minimum difference value; and if the difference is greater than or equal to the minimum difference value, continuing, by the computer system, the remote diagnostic testing session; otherwise, providing, by the computer system via the user device, an indication to the user that the difference is less than the minimum difference value.
In some aspects, the techniques described herein relate to a method, further including: identifying, by the computer system, a color calibration area; extracting, by the computer system, a first color value from a first portion of the color calibration area; and adjusting, by the computer system, the first image frame based on a difference between the first color value and a first reference color value.
In some aspects, the techniques described herein relate to a method, further including: extracting, by the computer system, a second color value from a second portion of the color calibration area; and adjusting, by the computer system, the first image frame based on a difference between the second color value and a second reference color value.
In some aspects, the techniques described herein relate to a method, further including: determining, by the computer system based on the unique identifier, an expiration date of a test kit associated with the reference card; and validating, by the computer system, that the test kit is not expired.
In some aspects, the techniques described herein relate to a method, further including: querying, by the computer system based on the unique identifier, a database; and receiving, by the computer system from the database, information about the test, the information including one or more of reference card feature locations, test strip interpretation information, test strip line locations, and testing procedures.
In some aspects, the techniques described herein relate to a method, further including: determining, by the computer system, a sharpness of the first image frame.
In some aspects, the techniques described herein relate to a system for remote diagnostic testing including: a non-transitory computer-readable medium with instructions encoded thereon; and one or more processors configured to execute the instructions to cause the system to: receive, by a computer system from a user device, a first image frame; determine a first area of the first image frame; identify a first feature in the first area; and provide, to a user via the user device, an indication that the first feature is in the first area of the first image frame; and continue a remote diagnostic testing session.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: receive, by the computer system from the user device, a second image frame; identify a second area of the second image frame; determine that the first feature is not within the second area of the second image frame; provide, to the user via the user device, an indication that the first feature is not in the second area of the second image frame; and pause the remote diagnostic testing session.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: receive, by the computer system form the user device, a third image frame; identify a third area of the third image frame; determine that the first feature is within the third area of the third image frame; provide, to the user via the user device, an indication that the first feature is within the third area of the third image frame; and resume the remote diagnostic testing session.
In some aspects, the techniques described herein relate to a system, wherein the second area is the same as the first area and the third area is the same as the second area.
In some aspects, the techniques described herein relate to a system, wherein the first feature includes a test kit, a swab, a test strip, a reagent bottle, or a reference card.
In some aspects, the techniques described herein relate to a system, wherein the first feature includes a reference card.
In some aspects, the techniques described herein relate to a system, wherein the reference card includes a unique identifier of a test.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: detect one or more fiducials in the first image frame; and adjust an alignment of the first image frame, wherein adjusted the alignment includes adjust one or more of skew and keystone.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: identify a detection threshold calibration area; determine a first color of a first region of the detection threshold calibration area; determine a second color of a second region of the detection threshold calibration area; determine if a difference between the first color and the second color is greater than or equal to a minimum difference value; and if the difference is greater than or equal to the minimum difference value, continue the remote diagnostic testing session; otherwise, provide, via the user device, an indication to the user that the difference is less than the minimum difference value.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: identify a color calibration area; extract a first color value from a first portion of the color calibration area; and adjust the first image frame based on a difference between the first color value and a first reference color value.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: extract a second color value from a second portion of the color calibration area; and adjust the first image frame based on the difference between the second color value and a second reference color value.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: determine, by the computer system based on the unique identifier, an expiration date of a test kit associated with the reference card; and validate that the test kit is not expired.
In some aspects, the techniques described herein relate to a system, wherein the instructions, when executed by the one or more processors, further cause the system to: query, by the computer system based on the unique identifier, a database; and receive, by the computer system from the database, information about the test, the information including one or more of reference card feature locations, test strip interpretation information, test strip line locations, and testing procedures.
In some aspects, the techniques described herein relate to a system wherein the instructions, when executed by the one or more processors, further cause the system to determine a sharpness of the first image frame.
For purposes of this summary, certain aspects, advantages, and novel features of the invention are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
All of these embodiments are intended to be within the scope of the invention herein disclosed. These and other embodiments will become readily apparent to those skilled in the art from the following detailed description having reference to the attached figures, the invention not being limited to any particular disclosed embodiment(s).
The drawings are provided to illustrate example embodiments and are not intended to limit the scope of the disclosure. A better understanding of the systems and methods described herein will be appreciated upon reference to the following description in conjunction with the accompanying drawings, wherein:
Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present technology.
Some embodiments herein are directed to health testing and diagnostics kits, as well as testing platforms related thereto. In some embodiments, the kits and/or platforms can facilitate remote health testing via remote connection of patients and medical providers. Remote or at-home medical testing provides various benefits over in-person visits to medical professionals. For example, remote or at-home medical testing provides both safety and convenience to patients and medical professionals. In-person visits by individuals with infectious diseases can endanger both medical professionals and anyone who encounters the individuals on their way to the in-person visit. Remote or at-home testing, in contrast, may not involve personal contact between the patient and any other individuals who may otherwise be at risk. Furthermore, at-home testing can be more convenient for many individuals, as neither medical providers nor patients need to leave the safety or comfort of their homes in order to administer or take a test using remote testing kits and platforms. In some cases, at-home testing may be done at any time of day on any day of the year. For example, at-home medical testing may be performed on weekends, holidays, at night, and/or at other times when an individual's regular doctor, urgent care provider, and so forth may be unavailable.
Additionally, because of advancements in medical and logistics technology, at-home testing can now be extremely fast. In some cases, diagnostic tests can be administered and read within seconds. Other tests may require a cure time before being read or may require delivery to a laboratory to receive results, but results can still be received within days in most cases.
Applications for remote or at-home medical testing are abundant. For example, remote or at-home testing can be used by travelers in any location to ensure that the traveler is healthy before and/or after arriving at a destination, without having to locate medical care in an unfamiliar locale. Furthermore, remote, or at-home testing may prevent the spread of infectious diseases by providing travelers knowledge about their health and their potential to transmit infectious diseases to others. This information may be used to inform a user's decisions to quarantine or avoid traveling altogether, and/or to avoid bringing home an infectious disease. Remote or at-home testing may also be useful for reducing stress and anxiety in sensitive individuals such as the elderly, chronically ill, and children. Remote or at-home testing may provide a better experience for such sensitive individuals, especially in cases in which the testing procedure is uncomfortable or invasive. Remote or at-home testing can mean that the test is done in a safe, comfortable, and familiar environment, so sensitive individuals may feel less stressed and worried during their test. This may allow testing to proceed more smoothly, may improve the overall experience of the user, and may lead to more frequent testing.
In some instances, remote or at-home testing can be performed in a user's home, although this need not be the case in all instances. For example, as used herein, remote, or at-home testing can refer to testing performed in other locations outside the home, such as in hotel rooms, airports, or other remote locations where access to an in-person healthcare provider is not available or desirable. Another consideration for remote or at-home testing is privacy. Remote or at-home testing can be private and discreet, which may be ideal for high-profile individuals or sensitive individuals who want to get tested without leaving their homes. Also, accessibility considerations favor remote or at-home testing. Remote or at-home testing can be ideal for anyone who has transportation issues or mobility/accessibility considerations.
Some embodiments herein are directed to a health testing and diagnostics platform for facilitating remote health testing via remote connection of patients and medical providers. Some embodiments are directed to test kit materials for facilitating remote medical testing. Some embodiments herein are directed to device stands that are configured to hold a user device, such as a smartphone, tablet, laptop, personal computer, or other type of personal device, during administration of a health or diagnostic test. The device stand can be configured to position the user device relative to one or more of the user, the test kit, or other testing materials during administration of the health or diagnostic test. In some embodiments, the device stand positions the user device such that one or more of the user, the test kit, or other testing materials are positioned with in the field of view(s) of one or more cameras of the user device (e.g., forward and/or rearward facing cameras). In some embodiments, one or more cameras may be built into the user device. In other embodiments, a camera can be external, for example connected using a USB connection. In some embodiments, the device stands are configured such that the user can still view a display on the user device so as to view testing information that is presented to the user on the display, such as a proctor, AR-based guidance, text, timers, or other testing instructions on the display of the user device while the user device is in the device stand. The device stands can thus facilitate remote or at-home medical testing.
In general, remote health testing and diagnostics can involve a user or patient interacting with a healthcare provider, automated system, etc., using a personal user device, such as a personal computer, a cellular phone, a smartphone, a laptop, a tablet computer, an e-reader device, an audio player, or another device capable of connecting to and communicating over a network, whether wired or wireless. In some embodiments, the healthcare provider can be a live person (e.g., a doctor, nurse, or other healthcare professional). In some embodiments, the user can interact with an automated system, such as pre-recorded step-by-step instructions or an artificial intelligence (AI) system. In some embodiments, remote healthcare can be provided by a mix of a live person, pre-recorded steps, and/or artificial intelligence systems.
In some embodiments, at-home healthcare testing or diagnostics can involve the use of a test kit. The test kit can include one or more items for administering a health or diagnostic test. In some embodiments, the user may film themselves taking the health or diagnostic test using the test kit using their user device (e.g., via a live online video stream and/or a recording stored locally on the user's device, which may be uploaded to a remote system and/or processed locally). In some embodiments, the user may also film the test kit during administration of the test. In some embodiments, the user may communicate with a healthcare professional using the user device during administration of the test. In some embodiments, the healthcare professional may be presented with video of the user using the test kit during administration of the test.
In some embodiments, the user can be instructed to position the test kit such that portions of the test kit that will be used during the testing process are within the view of the user device's camera and can be viewed by the user on the user device's screen. In this manner, guidance for how to perform the test can be presented overlaid onto the user's screen. The guidance can be provided using one or more of step-by-step instructions, text, demonstration videos, augmented reality (AR) content, schematic representations, and/or audible instructions. In one example, the user may need to add drops of a liquid to a specific portion of the test kit during administration of the test. Guidance in the form of an augmented reality animation can be overlaid onto the user's screen in a location corresponding to the displayed contents of the user's actual test kit to indicate where the user should place the drops of solution. As another example, when the user needs to access a swab within the test kit, the location of the swab can be highlighted using AR on the user's screen.
In some embodiments, it may be desirable to position the user device relative to the user and the test kit in a specific orientation, for example, in a specific orientation that allows for the user and the test kit to be within view of at least one camera on the user's device and that allows for the user to easily see the display screen of the user device. It may further be desirable to position the user device relative to the test kit within the field of view of the user device's camera such that guidance (e.g., AR guidance) can be overlaid thereon.
In some embodiments, both a user's face and test kit materials must be within the FOV of a camera of a user device. In some embodiments, a user's face must be within the FOV of a camera of a user device. In some embodiments, test kit materials must be within the FOV of a camera of a user device. In some embodiments, specific items from a test kit must be within the FOV. In some cases, users of remote medical testing may encounter difficulty ensuring that the user, the testing kit materials, or both are within the field of view of a camera. Augmented reality and/or computer vision techniques may be used to assist users with remote medical testing.
In some embodiments, augmented reality and/or computer vision techniques may be used to guide a user to position the user's face and/or another part of the user's body within the FOV of a camera. In some embodiments, augmented reality and/or computer vision techniques may be used to guide the user to place test kit materials within the FOV of a camera. In some embodiments, the user may be guided to place the user's face in a particular region of the FOV. In some embodiments, the user may be guided to place the test kit materials in a particular region of the field of view. For example, in some embodiments, a user may be directed to place the user's face inside a first bounding box. In some embodiments, a user maybe directed to place test kit materials inside a second bounding box. While the term “bounding box” is used herein, it is not intended to be limiting. It will be understood that a bounding box could be any shape such as, for example, a square, a rectangle, a circle, an oval, a triangle, or any other two-dimensional shape. In some embodiments, a bounding box may represent the shape of a body part or one or more test kit materials.
In some embodiments, a stream of image frames may be captured by a camera of a user device. In some embodiments, one or more images of the stream of image frames may be modified with augmented reality content which may include, for example, one or more bounding boxes. In some embodiments, a surface in the FOV may be identified, for example a tabletop. In some embodiments, a bounding box may be overlaid onto an identified surface. In some embodiments, a stream of image frames may be displayed on a display of a user device. In some embodiments, a stream of modified image frames containing one or more bounding boxes may be displayed on a display of a user device. The bounding box may be used to, for example, indicate where a user should place testing materials.
In some embodiments, a machine learning model may be trained to recognize test kit materials. In some embodiments, a machine learning model may recognize a specific test based on, for example, the test kit packaging. In some embodiments, a machine learning model may recognize one or more test kit materials. In some embodiments, a machine learning model may be trained to recognize a changed test kit such as, for example, if a manufacturer updates its packaging. In some embodiments, a machine learning model may be trained to recognize a planar area such as, for example, a table surface. In some embodiments, a machine learning model may be trained to recognize a face or other body part.
In some embodiments, the systems, methods, and devices described herein may be configured to determine whether a face of a user associated with the user device is positioned within a first bounding box. In some embodiments, the systems, methods, and devices described herein may be configured to determine if one or more medical diagnostic testing materials are positioned within a second bounding box. In some embodiments, more than two bounding boxes may be used. In some embodiments, the user may be instructed to move the face of the user, another body part of the user, and/or one or more medical diagnostic testing materials. In some embodiments, in response to determining that the face of the user associated with the user device is positioned within a first bounding box and determining that one or more medical diagnostic materials are positioned with a second bounding box, the systems, methods, and devices described herein may perform one or more operations to guide the user through a testing procedure. In some embodiments, the user may be shown an indication that a face and/or other body part is within a bounding box. In some embodiments, an indication may be, for example, an audio notification, a display on the screen such as, for example, a checkbox, an animation, or some other indication.
In some embodiments, the user may move out of a bounding box and/or out of the FOV of the camera of the user device. In some embodiments, the user may be prompted to move back within the FOV of the camera and/or back within the bounding box. In some embodiments, the user may move one or more diagnostic testing materials out of a bounding box and/or out of the FOV of the camera of the user device. In some embodiments, the user may be prompted to move the one or more diagnostic materials back into the FOV of the camera and/or back within the bounding box. In some embodiments, a prompt may consist of text, audio, and/or video, or some other means of notifying the user that action is needed.
With reference to
While the examples in
As discussed above, it can be important to ensure that the user, test kit materials, or both remain in view of one or more cameras during a testing session. Users may encounter difficulty placing test kit materials and/or themselves in appropriate locations and maintaining proper positioning through the testing session. Accordingly, in some embodiments, a test kit can be designed in a way that aids the user in properly setting up their environment.
The relative positioning between the user 302, the user device 304, and the test kit 312 as illustrated in
For example, during a first portion of the testing procedure, the output of the rearward-facing camera (e.g., FOV 310 in which is positioned the test kit 312) can be displayed to the user such that the user can view the test kit 312 on the display of the user device 304. The display can be updated with AR-based guidance to highlight certain areas of the test kit 312 or items in the test kit 312. The real-time video display of FOV 310 as presented on the user device's screen may additionally or alternatively be overlaid with other types of instructions to aid the user in performing the testing procedure. Audio instructions may be included and may be presented to the user by speakers on the user device 304. During another portion of the testing procedure, the output of the forward-facing camera (e.g., FOV 308 in which the user 302 is positioned) can be displayed to the user such that the user can view himself or herself in real time on the display of the user device 304. The real-time user video displayed to the user can be modified to include AR-based guidance to highlight certain areas of the user (e.g., a nostril) and/or may be overlaid with other types of instructions to aid the user in performing the testing procedure.
In some embodiments, the setup illustrated in
Although the setup illustrated in
Use of a device stand, for example, as illustrated in
In some embodiments, it may be advantageous to use a single user device position that can persist throughout the test. For example, this can allow the user and the test kit to be seen simultaneously, ensuring that the same user persists through the test while all steps are completed. Maintaining the user and the test kit within view of the user device throughout the testing session may improve test security and may also bolster validity of the test results. Additionally, in some embodiments, maintaining the user device in a single position improves the user experience by reducing testing complexity. For example, the user will not need to reposition the phone one or more times during the test if the user device remains positioned in a stationary position using a stand.
In some embodiments, the device stands are configured such that they do not occlude or block the rear camera of the user device. This can allow the rearward-facing camera of the user device to be used to scan a QR code, assist in reading test results, etc., without having to reposition the device.
In some embodiments, factors that may be relevant to the design of a mobile device stand for use with remote or at-home health or diagnostic testing can include the complexity of the stand design, portability of the stand, reusability of the test, the desired distance between the user device and the user, the desired distance between the user device and the test kit, the number and positions of the cameras on the user device that are used during a testing procedure, the size and weight of the user device, as well as the type of testing to be performed, among others. In some embodiments, a test kit can be designed to enable consistent placement of test components, the user device, and so forth, which may enable a smoother user experience and reduce the likelihood of an error being made during a testing procedure.
The recess 822 may further receive a packaged swab 806 and/or a packaged test strip 808. The insert 802b may include a hollow bottom volume 824 between a top surface of the insert and the packaging portion of the box 802a. Within the volume 824, additional test kit components may be stored such as the reference card 810, folded user device stand 814, and/or instructions or other advertising or informational material (not shown). In addition to recesses configured to hold various test kit components at one or more stages of test storage, shipping, and use, the insert 802b may include one or more recesses 826 configured to assist a user in removing the insert 802b from the box 802a. The recesses 826 may be configured to receive a user's thumb and finger as the user makes a pinching motion and removes the insert from the box. This allows the user to lift the insert out of the box without dumping out the contents in a way where components could be lost or contaminated.
Below, various other designs and configurations for mobile device stands will be discussed with reference to the examples illustrated in the figures. It will be appreciated that other stand designs are also possible based upon the examples and principles described herein. Accordingly, this disclosure should not be limited to only the illustrated examples.
In some embodiments, the mobile device stand can be included in the kit (e.g., as a discrete component), or it can be integrated into the box or other packaging that makes up the kit materials (e.g., as a foldable structure). For example, in the embodiment described with respect to
The stand configuration 1500 illustrated in
Proper camera placement, for example as may be enabled by one or more of the embodiments described herein, can improve a user testing experience, but difficulties may still be encountered during a testing session. Accordingly, a test kit may be otherwise adapted to enable easy use by even novice users. In some embodiments, the test kit can be configured to facilitate monitoring or test result determination and/or interpretation by a remote proctor, a computer system, or both. It can be important for test materials to be placed and/or oriented properly so that the user, a remote proctor, or an automated computer system can monitor the testing session and determine if steps have been performed properly, if results are valid, and so forth. For example, invalid results can result from improper test-taking procedures (for example, not inserting a test swab sufficiently far into a solution, a user touching an active portion of a test strip, and so forth). Poor image quality (for example, lack of focus, poor lighting, poor color calibration, etc.) can make it difficult or even impossible for a remote proctor or computer system to accurately determine whether a testing procedure has been followed correctly and/or whether a result is positive, negative, or indeterminate.
The reference card may be a printed piece of cardstock, plastic, etc., with various elements and may be designed to include or exclude elements depending on test type or other factors. In some embodiments, the card may serve as background when taking an image of the test strip, so that all results images can be standardized. The card may provide a unique code 1904 (e.g., a QR Code) that can be quickly and reliably identified and scanned by a computer vision process. In some test methods, the code may be scanned before a user takes a test and after the user takes the test to ensure test continuity and security. The code may be referenced to a database containing lot number, expiration date, and other information specific to the user's test.
Various features that aid in obtaining an optimal camera image, from which results can be interpreted (e.g., by a trained guide or computer vision algorithm), may be included. For example, graduated color stripes 1910 (which may be, for example, of a constant hue and varying saturation and/or brightness) may be printed on the card, and an image that includes the stripes may be provided to a computer vision algorithm. If the algorithm can identify all shades of stripes, lightest through darkest, that image is considered to have sufficient quality for accurately detecting the result stripes. Similarly, color references 1908 may be included. The color references may be blocks or other printed areas that include known colors on which color calibration (e.g., white balance, contrast enhancement, etc.) may be based. In some embodiments, a system can be configured to extract graduated color stripes and/or color references from an image. In some embodiments, the system can recommend changes to lighting conditions, distance, etc., to improve image quality. In some embodiments, the system can adjust the color of the images using the extracted color references and known color references. This calibration step may assist results in performing accurate test result interpretation.
Various fiducials 1902 may be included on the card to aid in position calibration of the image and to provide an image post-processing algorithm with a basis upon which distortion correction may be performed (for example, removing a skew or keystone effect). One or more of the features described above may be used as part of an image pre-check before the user completes the testing process. The pre-check may use the features to determine whether adequate lighting is present, whether angle adjustments of the user device are needed, or whether other image quality adjustments are needed. If one or more of the pre-check items needs adjusting ahead of the test session, the image check algorithm or the test system may indicate to the user to make such adjustments (e.g., “please turn on a brighter light” or “please rotate the kit to face the nearest window”). An example method and process flow for such an image validation process is illustrated in
In some embodiments, the icon 2104 or other fiducial on the test strip (e.g., on the grip) can aid an AI or CV system in identifying the test strip within an image. The fiducial marker or other recognizable color or image may also be used in determining where the user is touching the test strip. For example, if the user's fingers are not positioned on the correct portion of the strip and are located on the chemically active test strip area, a proctor or other test security process may review the images to determine if the test is still valid. Further,
As shown in
In some embodiments, the height h3 of the swab 2304 and the height h4 of the test strip 2306 can be less than the height h6 of the reference card 2308. This can ensure that, when positioned in the testing configuration the swab and test strip are positioned in front of the reference card.
In some embodiments, the height h5 of the results stripes region on the test strip is greater than the height h1 of the sample tube. This can help to ensure that the results are visible to a user, a proctor, and/or a user device camera when the test strip is inserted into the sample tube.
In the illustrated example, the sample tube also includes a keying feature 2806 configured to correspond to a related feature 2808 in the packaging to specify the orientation of the sample tube 2800 relative to the packaging. This can be configured to ensure a desired orientation of the swab and test strip slots 2802 and 2804. For example, the sample tube 2800 may be keyed such that when inserted properly into the insert, the sample tube positions the test strip such that a results region of the test strip is viewable by a user device camera. In some embodiments, the plurality of slots provided in the sample tube may have different shapes. The shape of each slot may correspond to the particular test kit component that each slot is designed to receive. For example, the swab slot 2802 may be a circular slot to accommodate the circular cross-sectional shape and size of the swab while the test strip slot 2804 may be a rectangular slot to accommodate the rectangular cross-sectional shape and size of the test strip. Such a shape and size correlation between slot and test component may help a user to intuit which component should be placed in which slot to improve accuracy of the test process and to improve ease of use for the user.
At 3106, a computing system can be configured to align the image using one or more fiducials on the reference card. In some embodiments, the fiducials may be distinct features, while in other embodiments, the fiducials may be included in other features of the reference card, for example within the QR code. Aligning the image can include, for example, deskewing, removing keystoning, and so forth. At 3108, the system can perform color corrections to the image, for example using known reference colors printed onto the reference card. At 3110, the system may check to ensure that the user's device is capable of detecting a range of color shades (e.g., from light pink to dark pink) that are printed on the test card (for example, to ensure that the user's device can be used to detect a faint strip of color on a test strip). For example, a reference card can include a detection threshold calibration region having multiple color samples ranging from very light to relatively dark. At 3112, the system may check the sharpness of the image using a computer vision algorithm. After checking one or more of the above indicators of image quality, the system can decide if the image is of sufficient quality to be used in assisting with test result interpretation at 3114. If the image is not of sufficient quality, the system can, at 3116, prompt the user to take another photo with better lighting, less motion, no obstructions, etc. The new image can be processed through the same method to check for image quality. If the image passes the quality check, the image may continue on and be used in a results interpretation step 3118 where the test strip is compared to colors and/or shades printed on the reference card or to a reference that can be used to determine if a result is positive or negative.
While the preceding disclosure provides examples related to medical testing procedures, the disclosures herein can also have other applications, such as aiding users in taking their prescription and/or non-prescription medications.
The application can instruct the user to open the appropriate compartment of the medication container (e.g., the Saturday morning compartment) and place the contents (e.g., pills, injections, syrups, etc.) in a designated area that is within a field of view of the camera. In some embodiments, a proctor or a computer vision algorithm can be configured to determine and verify which compartment was opened as well as the quantity, color, shape, lettering, or other markings (if present), and size of all pills or other medications in the area. In some embodiments, color and size can be determined using a printed fiducial/code next to the medication area as a reference. The determined type and quantity of medication present in the medication area can then be verified against the patient's medication schedule. Upon verification, the user can be instructed to take the medication. Otherwise, the user is alerted to any problems found (e.g., removal of wrong medication or the wrong quantities of medication). In some embodiments, a proctor or a computer vision algorithm can also be configured to verify that the user has properly ingested or otherwise taken the medication as instructed, for example using a forward-facing camera of the user device.
In some embodiments, the application can determine if there are known drug interactions. In some embodiments, the user can input information such as supplements, dietary practices, exercise, and so forth, and the application can use the user inputs to determine if there are possible interactions or other issues. In some embodiments, the application can be configured to provide warnings and/or notifications. For example, the application can provide a notification to the user when it is time to take a medication. In some embodiments, the application can alert a user than a dose has been missed. In some embodiments, the application can provide guidance such as reminding the user to take a medication with food, without food, at bedtime, after exercising, and so forth. In some embodiments, the application can be configured to provide warnings to the user, such as a warning to avoid taking a common over-the-counter medication that is known to have an adverse interaction with one or more of the user's prescription or non-prescription medications.
In some embodiments, the packaging (e.g., a lid of the box) could have the medication container built in such that the medication container is integrated, attached, or otherwise fixed to the packaging. As discussed above, the medication container (e.g., a pill dispenser) could be pre-filled with the user's prescription(s), and the box with pills included can be shipped to the user as a kit. In some embodiments, kits can be sent weekly or monthly. In some embodiments, the kits can comprise inexpensive materials, such as cardboard or plastic, and can be recyclable and/or compostable after use. In addition to pills, test kits can be configured to monitor other medical parameters, such as glucose monitoring.
In some embodiments, the systems, processes, and methods described herein are implemented using a computing system, such as the one illustrated in
The computer system 3402 can comprise a health testing and diagnostic module 3414 that carries out the functions, methods, acts, and/or processes described herein. The health testing and diagnostic module 3414 is executed on the computer system 3402 by a central processing unit 3406 discussed further below.
In general, the word “module,” as used herein, refers to logic embodied in hardware or firmware or to a collection of software instructions, having entry and exit points. Modules are written in a program language, such as JAVA, C or C++, PYTHON, or the like. Software modules may be compiled or linked into an executable program, installed in a dynamic link library, or may be written in an interpreted language such as BASIC, PERL, LUA, or Python. Software modules may be called from other modules or from themselves, and/or may be invoked in response to detected events or interruptions. Modules implemented in hardware include connected logic units such as gates and flip-flops, and/or may include programmable units, such as programmable gate arrays or processors.
Generally, the modules described herein refer to logical modules that may be combined with other modules or divided into sub-modules despite their physical organization or storage. The modules are executed by one or more computing systems and may be stored on or within any suitable computer readable medium or implemented in-whole or in
part within special designed hardware or firmware. Not all calculations, analysis, and/or optimization require the use of computer systems, though any of the above-described methods, calculations, processes, or analyses may be facilitated through the use of computers. Further, in some embodiments, process blocks described herein may be altered, rearranged, combined, and/or omitted.
The computer system 3402 includes one or more processing units (CPU) 3406, which may comprise a microprocessor. The computer system 3402 further includes a physical memory 3410, such as random-access memory (RAM) for temporary storage of information, a read only memory (ROM) for permanent storage of information, and a mass storage device 3404, such as a backing store, hard drive, rotating magnetic disks, solid state disks (SSD), flash memory, phase-change memory (PCM), 3D XPoint memory, diskette, or optical media storage device. Alternatively, the mass storage device may be implemented in an array of servers. Typically, the components of the computer system 3402 are connected to the computer using a standards-based bus system. The bus system can be implemented using various protocols, such as Peripheral Component Interconnect (PCI), Micro Channel, SCSI, Industrial Standard Architecture (ISA) and Extended ISA (EISA) architectures.
The computer system 3402 includes one or more input/output (I/O) devices and interfaces 3412, such as a keyboard, mouse, touch pad, and printer. The I/O devices and interfaces 3412 can include one or more display devices, such as a monitor, that allows the visual presentation of data to a user. More particularly, a display device provides for the presentation of GUIs as application software data, and multi-media presentations, for example. The I/O devices and interfaces 3412 can also provide a communications interface to various external devices. The computer system 3402 may comprise one or more multi-media devices 3408, such as speakers, video cards, graphics accelerators, and microphones, for example.
The computer system 3402 may run on a variety of computing devices, such as a server, a Windows server, a Structure Query Language server, a Unix Server, a personal computer, a laptop computer, and so forth. In other embodiments, the computer system 3402 may run on a cluster computer system, a mainframe computer system and/or other computing system suitable for controlling and/or communicating with large databases, performing high volume transaction processing, and generating reports from large databases. The computing system 3402 is generally controlled and coordinated by an operating system software, such as z/OS, Windows, Linux, UNIX, BSD, SunOS, Solaris, MacOS, or other compatible operating systems, including proprietary operating systems. Operating systems control and schedule computer processes for execution, perform memory management, provide file system, networking, and I/O services, and provide a user interface, such as a graphical user interface (GUI), among other things.
The computer system 3402 illustrated in
Access to the health testing and diagnostic module 3414 of the computer system 3402 by computing systems 3420 and/or by data sources 3422 may be through a web enabled user access point such as the computing systems' 3420 or data source's 3422 personal computer, cellular phone, smartphone, laptop, tablet computer, e-reader device, audio player, or another device capable of connecting to the network 3418. Such a device may have a browser module that is implemented as a module that uses text, graphics, audio, video, and other media to present data and to allow interaction with data via the network 3418.
The output module may be implemented as a combination of an all-points addressable display such as a cathode ray tube (CRT), a liquid crystal display (LCD), a plasma display, or other types and/or combinations of displays. The output module may be implemented to communicate with input devices 3412 and they also include software with the appropriate interfaces which allow a user to access data through the use of stylized screen elements, such as menus, windows, dialogue boxes, tool bars, and controls (for example, radio buttons, check boxes, sliding scales, and so forth). Furthermore, the output module may communicate with a set of input and output devices to receive signals from the user.
The input device(s) may comprise a keyboard, roller ball, pen and stylus, mouse, trackball, voice recognition system, or pre-designated switches or buttons. The output device(s) may comprise a speaker, a display screen, a printer, or a voice synthesizer. In addition, a touch screen may act as a hybrid input/output device. In another embodiment, a user may interact with the system more directly such as through a system terminal connected to the score generator without communications over the Internet, a WAN, or LAN, or similar network.
In some embodiments, the system 3402 may comprise a physical or logical connection established between a remote microprocessor and a mainframe host computer for the express purpose of uploading, downloading, or viewing interactive data and databases online in real time. The remote microprocessor may be operated by an entity operating the computer system 3402, including the client server systems or the main server system, an/or may be operated by one or more of the data sources 3422 and/or one or more of the computing systems 3420. In some embodiments, terminal emulation software may be used on the microprocessor for participating in the micro-mainframe link.
In some embodiments, computing systems 3420 who are internal to an entity operating the computer system 3402 may access the health testing and diagnostic module 3414 internally as an application or process run by the CPU 3406.
In some embodiments, one or more features of the systems, methods, and devices described herein can utilize a URL and/or cookies, for example for storing and/or transmitting data or user information. A Uniform Resource Locator (URL) can include a web address and/or a reference to a web resource that is stored on a database and/or a server. The URL can specify the location of the resource on a computer and/or a computer network. The URL can include a mechanism to retrieve the network resource. The source of the network resource can receive a URL, identify the location of the web resource, and transmit the web resource back to the requestor. A URL can be converted to an IP address, and a Domain Name System (DNS) can look up the URL and its corresponding IP address. URLs can be references to web pages, file transfers, emails, database accesses, and other applications. The URLs can include a sequence of characters that identify a path, domain name, a file extension, a host name, a query, a fragment, scheme, a protocol identifier, a port number, a username, a password, a flag, an object, a resource name and/or the like. The systems disclosed herein can generate, receive, transmit, apply, parse, serialize, render, and/or perform an action on a URL.
A cookie, also referred to as an HTTP cookie, a web cookie, an internet cookie, and a browser cookie, can include data sent from a website and/or stored on a user's computer. This data can be stored by a user's web browser while the user is browsing. The cookies can include useful information for websites to remember prior browsing information, such as a shopping cart on an online store, clicking of buttons, login information, and/or record of web pages or network resources visited in the past. Cookies can also include information that the user enters, such as names, addresses, passwords, credit card information, etc. Cookies can also perform computer functions. For example, authentication cookies can be used by applications (for example, a web browser) to identify whether the user is already logged in (for example, to a web site). The cookie data can be encrypted to provide security for the consumer. Tracking cookies can be used to compile historical browsing histories of individuals. Systems disclosed herein can generate and use cookies to access data of an individual. Systems can also generate and use JSON web tokens to store authenticity information, HTTP authentication as authentication protocols, IP addresses to track session or identity information, URLs, and the like.
The computing system 3402 may include one or more internal and/or external data sources (for example, data sources 3422). In some embodiments, one or more of the data repositories and the data sources described above may be implemented using a relational database, such as DB2, Sybase, Oracle, CodeBase, and Microsoft® SQL Server as well as other types of databases such as a flat-file database, an entity relationship database, and object-oriented database, and/or a record-based database.
The computer system 3402 may also access one or more databases 3422. The databases 3422 may be stored in a database or data repository. The computer system 3402 may access the one or more databases 3422 through a network 3418 or may directly access the database or data repository through I/O devices and interfaces 3412. The data repository storing the one or more databases 3422 may reside within the computer system 3402.
In some embodiments, a health testing and diagnostic platform 3502 may be comprised of a registration and purchase module 3504, a testing module 3506, an analytics module 3508, and a reporting module 3510. The health testing and diagnostic platform 3502 may also comprise a user profile database 3512, a proctor database 3514, a test database 3516, and/or a site database 3518. The health testing and diagnostic platform 3502 can be connected to a network 3520. The network 3520 can be configured to connect the health testing and diagnostic platform 3502 to one or more proctor devices 3522, one or more user devices 3524, one or more pharmacy systems 3526, one or more third-party provider systems 3528, and/or one or more government systems 3530.
The registration and purchase 3504 may function by facilitating patient registration through one or more registration interfaces and in conjunction with the user database 3512, store user registration data. The testing module 3506 may be configured to allow a user to initiate and complete a medical test or visit with a proctor through a series of pre-testing and testing interfaces, as described herein. The analytics module 3508 may be configured to dynamically analyze patient tests across a given population stored in the test database 3516 and provide structured data of the test results. The reporting module 3510 may function by dynamically and automatically reporting test results to government entities, patients, and third parties using one or more interfaces, such as one or more application programming interfaces. Each of the modules can be configured to interact with each other and the databases discussed herein.
In the foregoing specification, the invention has been described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense.
Indeed, although this invention has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. In addition, while several variations of the embodiments of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. It should be understood that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another in order to form varying modes of the embodiments of the disclosed invention. Any methods disclosed herein need not be performed in the order recited. Thus, it is intended that the scope of the invention herein disclosed should not be limited by the particular embodiments described above.
It will be appreciated that the systems and methods of the disclosure each have several innovative aspects, no single one of which is solely responsible or required for the desirable attributes disclosed herein. The various features and processes described above may be used independently of one another or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure.
Certain features that are described in this specification in the context of separate embodiments also may be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment also may be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination may in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination. No single feature or group of features is necessary or indispensable to each and every embodiment.
It will also be appreciated that conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. In addition, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. In addition, the articles “a,” “an,” and “the” as used in this application and the appended claims are to be construed to mean “one or more” or “at least one” unless specified otherwise. Similarly, while operations may be depicted in the drawings in a particular order, it is to be recognized that such operations need not be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Further, the drawings may schematically depict one more example processes in the form of a flowchart. However, other operations that are not depicted may be incorporated in the example methods and processes that are schematically illustrated. For example, one or more additional operations may be performed before, after, simultaneously, or between any of the illustrated operations. Additionally, the operations may be rearranged or reordered in other embodiments. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the embodiments described above should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems may generally be integrated together in a single software product or packaged into multiple software products. Additionally, other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve desirable results.
Further, while the methods and devices described herein may be susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but, to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various implementations described and the appended claims. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with an implementation or embodiment can be used in all other implementations or embodiments set forth herein. Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ±5%, ±10%, ±15%, etc.). For example, “about 3.5 mm” includes “3.5 mm.” Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances). For example, “substantially constant” includes “constant.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
As used herein, a phrase referring to “at least one of” a list of items refers to any combination of those items, including single members. As an example, “at least one of: A, B, or C” is intended to cover: A, B, C, A and B, A and C, B and C, and A, B, and C. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be at least one of X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present. The headings provided herein, if any, are for convenience only and do not necessarily affect the scope or meaning of the devices and methods disclosed herein.
Accordingly, the claims are not intended to be limited to the embodiments shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein.
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. This application claims the benefit under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 63/260,504, filed Aug. 23, 2021, U.S. Provisional Application No. 63/260,349, filed Aug. 17, 2021, entitled “SYSTEMS, METHODS, AND DEVICES FOR DIAGNOSTIC TEST KITS,” and 63/261,883, filed Sep. 30, 2021, entitled “POSITIONING GUIDANCE FOR REMOTE MEDICAL DIAGNOSTIC TESTING,” and the entirety of these applications is hereby incorporated by reference herein for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63260504 | Aug 2021 | US | |
| 63260349 | Aug 2021 | US | |
| 63261883 | Sep 2021 | US |
