“Systems, Methods, And Devices For Non-Human Readable Diagnostic Tests” in Patent Application Approval Process (USPTO 20220406458): Patent Application

2023 JAN 06 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- A patent application by the inventors Ferro, JR., Michael W. (Palm Beach, FL, US); Heising, James Thomas (Richard, WA, US); Kramer, Nicholas Atkinson (Wilton Manors, FL, US); Magistri, Marco (Miami, FL, US); Miller, Sam (Hollywood, FL, US); Nienstedt, Zachary Carl (Wilton Manors, FL, US), filed on June 21, 2022, was made available online on December 22, 2022, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

This patent application has not been assigned to a company or institution.

The following quote was obtained by the news editors from the background information supplied by the inventors: “

“Field

“The embodiments of the disclosure generally relate to diagnostic tests, and more particularly to systems, methods, and devices for ensuring the integrity of testing processes and results.

“Description

“Use of telehealth to deliver healthcare 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 user device, such as a smart phone, tablet, laptop, personal computer, or other type of user device. For example, the user or patient can administer a health-related test remotely through the user device. Additionally, the integrity of the health-related test will be measured.

“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 testing user, providing test delivery from a patient to an appropriate lab, guaranteeing timely result reporting from the appropriate lab to a patient, ensuring test result verification and integrity, providing test result reporting to appropriate authorities and medical providers, and connecting patients with medical providers who may be needed to provide guidance and/or oversight of the testing procedures and results remotely.”

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors’ summary information for this patent application: “Health testing and diagnostics integrity may be important to the administration of medical health and diagnostic tests. In some instances, test integrity may require ensuring that the user is administering the proper test throughout the duration of the test. Unfortunately, this is not always the case. For example, the proper user may not be the individual administering the test, the test may not be valid, there may be test discontinuity, the test instructions may be unclear, there may be user discontinuity, the test may not have physical ease of use, etc. Remote or at home health testing and diagnostics can include tests which can be taken by a patient in his or her own home. In such cases, it may be desirable to have the test integrity measured at various points in time throughout the duration of the test, avoiding the concern for lack of test integrity and the associated problems discussed above.

“Embodiments of this application can provide test integrity measurements that can be used to measure or ensure test integrity throughout the duration of the test, for example, having the user provide test identification information such that the information can later be confirmed and validated at various points throughout the duration of the test. In some embodiments, the user may capture and submit information (which can, for example, be image-based, video-based, audio-based, or text-based) regarding the identifying information of the medical diagnostic test with the use of a user device, such as a smartphone, tablet, laptop, or personal computer. In some embodiments, the user may submit this information at more than one point of time during the administration of the test.

“For example, a user may make a first submission of test identifying information during a first phase of the administration of the test. Later, the user may be prompted to submit a second submission of test identifying information during a second phase of the administration of the test. A feature detection algorithm may be applied to the submitted information (e.g., the first and second submissions) to detect one or more features therein (e.g., features of medical diagnostic components of a particular type within the images). In some embodiments, the algorithm may determine whether the first and second sets of submissions indicate the same detected feature of a medical diagnostic component in each image. An indication that the same features are detected in each image can provide an indicator of test continuity. In some embodiments, a system can determine whether the user has remained in compliance with the medical diagnostic testing procedure based at least in part on whether the same medical diagnostic component of a particular type is determined to be shown in the first submission and second submission. This can, for example, beneficially eliminate the concern for lack of test integrity regarding remote health and diagnostic testing. This can provide an improved administration of remote or at-home health testing and diagnostics.

“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.

“In some aspects, the techniques described herein relate to a computer-implemented method of measuring compliance with a medical diagnostic testing procedure including: providing, by a computing system, a prompt to a user to present a medical diagnostic component to a camera of a user device, wherein the medical diagnostic component is included in a test kit; receiving, by the computing system, a first image captured by the camera; prompting, by the computing system, the user to present the medical diagnostic component to the camera of the user device; receiving, by the computing system, a second image captured by the camera; detecting, by the computing system, a first set of features associated with the first image and a second set of features associated with the second image; determining, by the computing system, if the medical diagnostic component in the first image is the same as the medical diagnostic component in the second image; and based at least in part on the determining, assessing, by the computing system, if the user remained in compliance with the medical diagnostic testing procedure.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the medical diagnostic test component is a test strip.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the test strip includes an identifier including any combination of one or more of: a QR code, a pattern, a graphic, an image, or a bar code.

“In some aspects, the techniques described herein relate to a method, wherein the identifier is unique to a particular test strip.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the medical diagnostic test component includes a pattern region.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the determining includes: determining, by the computing system, a first average color value of the first set of features and a second average color value of the second set of features; and comparing the first average color value and the second average color value.

“In some aspects, the techniques described herein relate to a computer-implemented method, further including: determining, by the computing system based on the first set of features, a first identifier; determining, by the computing system based on the second set of features, a second identifier; and determining, by the computing system, if the first identifier is the same as the second identifier.

“In some aspects, the techniques described herein relate to a computer-implemented method, further including: determining, by the computing system, a first plurality of identifiers based on the first set of features; determining, by the computing system, a second plurality of identifiers based on the second set of features; and mapping each identifier of the first plurality of identifiers and the second plurality of identifiers to a hash space including hash values.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein mapping each identifier to a hash space includes performing a transformation on at least one identifier of the first and second pluralities of identifiers.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the transformation includes: color matching, a scale-invariant feature transform, a convolution transform against a template, thresholding, color matching, edge detection, or overlap detection.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the determining includes: determining a difference in the hash values of the first plurality of identifiers and the hash values of the second plurality of identifiers.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the difference in hash values is a Hamming distance or a Levenshtein distance.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the medical diagnostic test component includes a reference region.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the reference region includes grayscale reference values.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the reference region includes color reference values.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the pattern includes a linear pattern, a color gradient, a grayscale gradient, a sine wave, a triangle wave, a square wave, or an arrangement of shapes.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the medical diagnostic component includes: a first region having a first pattern; a second region having a second pattern; and a third region having a third pattern, wherein the determining includes comparing the first, second, and third regions of the medical diagnostic component of the first image to the first, second, and third regions of the medical diagnostic component the second image.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the first pattern has a first frequency, wherein the second pattern has a second frequency that is different from the first frequency, and wherein the third pattern has a third frequency that is different from the first frequency and the second frequency.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein the first frequency is larger than the second frequency and the third frequency, wherein the second frequency is larger than the third frequency, and wherein at least one of the ratio of the first frequency to the second frequency, the ratio of the first frequency to the third frequency, and the ratio of the second frequency to the third frequency is not an integer.

“In some aspects, the techniques described herein relate to a computer-implemented method, wherein at least one of the ratios is an irrational number.”

There is additional summary information. Please visit full patent to read further.”

The claims supplied by the inventors are:

“1. A computer-implemented method of measuring compliance with a medical diagnostic testing procedure comprising: providing, by a computing system, a prompt to a user to present a medical diagnostic component to a camera of a user device, wherein the medical diagnostic component is included in a test kit; receiving, by the computing system, a first image captured by the camera; prompting, by the computing system, the user to present the medical diagnostic component to the camera of the user device; receiving, by the computing system, a second image captured by the camera; detecting, by the computing system, a first set of features associated with the first image and a second set of features associated with the second image; based on the first set of features and the second set of features, determining, by the computing system, that the medical diagnostic component in the first image is the same as the medical diagnostic component in the second image; and based at least in part on the determining, assessing, by the computing system, that the user remained in compliance with the medical diagnostic testing procedure.

“2. The computer-implemented method of claim 1, wherein the medical diagnostic test component is a test strip.

“3. The computer-implemented method of claim 2, wherein the test strip includes an identifier comprising any combination of one or more of: a QR code, a pattern, a graphic, an image, or a bar code.

“4. The method of claim 3, wherein the identifier is unique to a particular test strip.

“5. The computer-implemented method of claim 1, wherein the medical diagnostic test component comprises a pattern region.

“6. The computer-implemented method of claim 5, wherein the determining comprises: determining, by the computing system, a first average color value of the first set of features and a second average color value of the second set of features; and comparing the first average color value and the second average color value.

“7. The computer-implemented method of claim 1, further comprising: determining, by the computing system based on the first set of features, a first identifier; determining, by the computing system based on the second set of features, a second identifier; and determining, by the computing system, that the first identifier is the same as the second identifier.

“8. The computer-implemented method of claim 1, further comprising: determining, by the computing system, a first plurality of identifiers based on the first set of features; determining, by the computing system, a second plurality of identifiers based on the second set of features; and mapping each identifier of the first plurality of identifiers and the second plurality of identifiers to a hash space comprising hash values.

“9. The computer-implemented method of claim 8, wherein mapping each identifier to a hash space comprises performing a transformation on at least one identifier of the first and second pluralities of identifiers.

“10. The computer-implemented method of claim 9, wherein the transformation comprises: color matching, a scale-invariant feature transform, a convolution transform against a template, thresholding, color matching, edge detection, or overlap detection.

“11. The computer-implemented method of claim 8, wherein the determining comprises: determining a difference in the hash values of the first plurality of identifiers and the hash values of the second plurality of identifiers.

“12. The computer-implemented method of claim 11, wherein the difference in hash values is a Hamming distance or a Levenshtein distance.

“13. The computer-implemented method of claim 1, wherein the medical diagnostic test component comprises a reference region.

“14. The computer-implemented method of claim 13, wherein the reference region comprises grayscale reference values.

“15. The computer-implemented method of claim 13, wherein the reference region comprises color reference values.

“16. The computer-implemented method of claim 3, wherein the pattern comprises a linear pattern, a color gradient, a grayscale gradient, a sine wave, a triangle wave, a square wave, or an arrangement of shapes.

“17. The computer-implemented method of claim 1, wherein the medical diagnostic component comprises: a first region having a first pattern; a second region having a second pattern; and a third region having a third pattern, wherein the determining comprises comparing the first, second, and third regions of the medical diagnostic component of the first image to the first, second, and third regions of the medical diagnostic component the second image.

“18. The computer-implemented method of claim 17, wherein the first pattern has a first frequency, wherein the second pattern has a second frequency that is different from the first frequency, and wherein the third pattern has a third frequency that is different from the first frequency and the second frequency.

“19. The computer-implemented method of claim 18, wherein the first frequency is larger than the second frequency and the third frequency, wherein the second frequency is larger than the third frequency, and wherein at least one of the ratio of the first frequency to the second frequency, the ratio of the first frequency to the third frequency, and the ratio of the second frequency to the third frequency is not an integer.

“20. The computer-implemented method of claim 19, wherein at least one of the ratios is an irrational number.”

URL and more information on this patent application, see: Ferro, JR., Michael W.; Heising, James Thomas; Kramer, Nicholas Atkinson; Magistri, Marco; Miller, Sam; Nienstedt, Zachary Carl. Systems, Methods, And Devices For Non-Human Readable Diagnostic Tests. U.S. Patent Application Number 20220406458, filed June 21, 2022 and posted December 22, 2022. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20220406458)&db=US-PGPUB&type=ids

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