Diagnostic array

Abstract

The present invention relates to a diagnostic array that enables simultaneous detection and analysis of multiple target molecules in biological samples. This diagnostic device integrates various biological entities immobilized at distinct locations on a substrate with specific agents conjugated to these entities. The device produces detectable changes, such as colorimetric, fluorescent, or chemiluminescent signals, upon interaction with target molecules. A corresponding smartphone application captures and analyzes the results, providing immediate preliminary interpretations. This invention addresses the need for a comprehensive, user-friendly diagnostic tool suitable for point-of-care and home testing, ensuring secure data transmission for further professional analysis.

Description

[0001] TITLE: DIAGNOSTIC ARRAY

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS: US Provisional Application 63528428

[0003] FEDERALLY SPONSORED RESEARCH: None.

[0004] SEQUENCE LISTING: None.

[0005] SUMMARY:

[0006] The invention provides a diagnostic device, methods for its production and use, a smartphone application, and a home testing kit. The diagnostic device features multiple biological entities immobilized on a substrate, each conjugated with agents specific to known target molecules. These agents trigger a detectable signal upon binding with their targets, which can be visualized using various detection systems. The smartphone application captures images of these signals, analyzes them, and provides preliminary results. Additionally, it allows secure transmission of data to remote servers for further evaluation. The home testing kit includes the diagnostic device, sample collection instructions, and the smartphone application, enabling users to perform diagnostic tests at home efficiently. This invention aims to offer a versatile, reliable, and user-friendly diagnostic solution, enhancing accessibility and convenience in various settings, including resource-limited environments.

[0007] BACKGROUND

[0008] 1. Field of the Invention

[0009] The present invention relates to the field of diagnostics, particularly in relation to diagnostic assays, methods, and kits for the detection and analysis of target molecules in biological samples. More specifically, the invention pertains to a diagnostic microarray device incorporating a variety of biological entities and associated agents, and a corresponding smartphone application for capturing, analyzing, and interpreting test results.

[0010] 1. Description of the Related Art

[0011] Current diagnostic assays, such as Enzyme-Linked Immunosorbent Assay (ELISA), Lateral Flow Assays (LFA), and others, often target a single or limited set of biomarkers, and are therefore limited in their diagnostic scope. These assays, while effective for their specific targets, do not provide a broad-spectrum diagnostic tool that can simultaneously detect and analyze a variety of biomarkers.

[0012] Furthermore, traditional assays typically require specialized equipment and trained personnel to perform the tests and interpret the results, limiting their use to laboratory or clinical settings. As a result, these methods may not be suitable for home testing or for use in resource-limited settings.

[0013] DNA microarray technology, on the other hand, offers the possibility of simultaneous detection of multiple targets. However, existing microarray technologies have not yet been fully adapted to user-friendly, point-of-care testing and do not typically allow for immediate, on-site interpretation of results.

[0014] Hence, there exists a need for a comprehensive, versatile, and user-friendly diagnostic tool that can simultaneously detect multiple biomarkers, has potential for home use, and allows for immediate preliminary analysis and interpretation of results using everyday technology such as a smartphone. There is also a need for secure and confidential transmission of such sensitive diagnostic data for further analysis and interpretation by professional medical personnel.

[0015] The present invention seeks to address these needs and provides further related advantages.

[0016] SUMMARY

[0017] The present invention provides a diagnostic device, methods for its production and use, a corresponding smartphone application, and a home testing kit that overcome limitations of existing diagnostic technologies.

[0018] The diagnostic device comprises a plurality of biological entities immobilized at distinct locations on a surface (or within the substrate). The entities include predetermined DNA sequences or other biologically relevant molecules. A set of agents is conjugated to these biological entities, where each agent is specific to a known target molecule. Each biological entity can be repeated at multiple distinct locations on the surface (or within the substrate) to create redundancy, improving the reliability of the device.

[0019] A detection system is included that produces a detectable change — like a colorimetric, fluorescent, or chemiluminescent signal — in response to the binding between the agents and their respective target molecules. The diagnostic device can be adapted for use in various assay formats, including microarray, lateral flow, ELISA, or magnetic bead assays. Methods for producing and using the diagnostic device involve immobilizing biological entities at distinct locations on a surface (or within the substrate), conjugating a set of agents to these entities, introducing a patient's sample onto the device, detecting the binding between the agents and any corresponding target molecules in the sample, and producing a detectable change in response to this binding.

[0020] A smartphone application is designed to capture an image of the detectable change, analyze the results, and provide a preliminary analysis. The application incorporates image capture, analysis, and interpretation features. Additionally, it includes a remote analysis feature for uploading the image and the preliminary analysis to a remote server for further evaluation. Data privacy and security features are integrated to protect the confidentiality and integrity of the patient's data.

[0021] A home testing kit comprises the diagnostic device, instructions for introducing a patient's sample onto the device and detecting the detectable change, and the smartphone application for capturing an image of the detectable change, analyzing the results, and providing a preliminary analysis. This kit allows users to conduct point-of-care testing in a convenient, user-friendly manner while ensuring secure data transmission for further analysis.

[0022] The foregoing summary aims to provide a brief overview of the present invention and does not delve into comprehensive detail. Further details and embodiments are described in the detailed description and claims.

[0023] DETAILED DESCRIPTION

[0024] The following detailed description presents the invention in terms of embodiments and procedures, but the invention is not limited to these, as it can be embodied in different forms. The invention includes a diagnostic device, methods for its production and use, a smartphone application designed to work with the device, and a home testing kit incorporating the device and application.

[0025] The Diagnostic Device:

[0026] The core of the present invention is a diagnostic device designed as a microarray, which comprises a plurality of biological entities immobilized at distinct locations on a surface (or within a substrate). These entities could include predetermined DNA sequences, proteins, peptides, or other biologically relevant molecules. The device also includes a set of agents conjugated to the biological entities. Each agent is specific to a known target molecule. The agents can include, but are not limited to, proteins, peptides, microRNAs, metabolites, lipids, small molecules, or phage-displayed antigens. Each biological entity is typically repeated at multiple distinct locations on the surface (or within the substrate) to create redundancy, increasing the reliability of the device.

[0027] The device also includes a detection system that produces a detectable change in response to the binding between the agents and their respective target molecules. This detectable change could be a colorimetric, fluorescent, or chemiluminescent signal. The diagnostic device can be adapted for use in various assay formats, such as microarray, lateral flow, ELISA, or magnetic bead assays.

[0028] Methods for Device Production and Use: The invention also encompasses methods for producing and using the diagnostic device. The production method includes immobilizing a plurality of biological entities at distinct locations on a surface (or within the substrate) and conjugating a set of agents to these entities. In practice, each biological entity can be repeated at multiple distinct locations on the surface (or within the substrate) to create redundancy.

[0029] The method for using the diagnostic device includes introducing a patient's sample onto the device, detecting the binding between the agents and any corresponding target molecules in the sample, and producing a detectable change in response to this binding.

[0030] Lateral Flow Assay:

[0031] The diagnostic device of the present invention can be implemented as a lateral flow assay for rapid and convenient testing. The lateral flow assay operates under capillary action, which draws the patient's sample through the device to produce results.

[0032] The lateral flow device comprises a sample pad, a conjugate pad, a reaction matrix, and an absorbant pad. The sample pad serves as the area where the patient's biological sample, such as blood, saliva, or urine, is introduced. The sample pad is designed to accept the sample and allow it to move through the device via capillary action.

[0033] The conjugate pad is pre-loaded with agents that are conjugated to a detectable marker. These agents are designed to interact with specific target molecules that may be present in the patient's sample. The conjugate pad is typically kept in a dry state until the introduction of the sample, at which point the agents become soluble and can interact with the target molecules as the sample migrates through the device.

[0034] The reaction matrix, or test strip, is where the biological entities are immobilized. These entities may be specific DNA sequences, proteins, or other molecules that can interact with the target molecules in the patient's sample. As the sample moves through the device, the target molecules have the opportunity to bind to the immobilized biological entities, creating a detectable change.

[0035] Finally, the absorbent pad serves to draw the sample through the device by capillary action. It aids in the flow of the sample through the device, ensuring that the sample comes into contact with the conjugate pad and the reaction matrix.

[0036] The interaction between the agents and the target molecules, if present in the sample, results in a detectable change. This change can be colorimetric, fluorescent, or chemiluminescent, depending on the design of the device and the type of detectable marker used. For home use, a colorimetric change is often preferred as it can be easily visualized and interpreted without the need for specialized equipment.

[0037] In addition to the use of a smartphone application to capture an image of the detectable change, analyze the image, and provide a preliminary analysis of the test results, the lateral flow device may also include a control line or reference spot. This serves to validate the test by showing that the sample has successfully migrated through the device and that the agents are functioning correctly. This lateral flow implementation of the diagnostic device provides a rapid, convenient, and reliable method for patients to perform tests at home. It is suitable for a wide range of applications, including infectious disease testing, genetic testing, allergy testing, drug testing, and pregnancy testing, among others. By providing a means for patients to perform tests at home and receive immediate preliminary results, this invention represents a significant advancement in the field of home diagnostics.

[0038] Smartphone Application:

[0039] A smartphone application has been developed as part of the invention to work in conjunction with the diagnostic device. This application includes an image capture feature to capture an image of the detectable change on the device. It also includes an image analysis feature to identify the changes on the device corresponding to the binding between agents and their respective target molecules. A result interpretation feature correlates the changes with specific target molecules, producing a preliminary analysis of the test results.

[0040] The smartphone application includes a remote analysis feature to upload the image and the preliminary analysis to a remote server for further evaluation. Data privacy and security features are integrated to protect the confidentiality and integrity of the patient's data.

[0041] Home Testing Kit:

[0042] A home testing kit is another embodiment of the present invention. It includes the diagnostic device, instructions for introducing a patient's sample onto the device and detecting the detectable change, and the smartphone application. The application can capture an image of the detectable change, analyze the results, and provide a preliminary analysis. This allows users to conduct point-of-care testing in a convenient, user-friendly manner, while also ensuring secure data transmission for further analysis.

[0043] The above description and the following claims are not limited to the specific features or acts described, rather they are conceptualized in a variety of other ways to implement and practice the invention.

Claims

CLAIMS:

1. A diagnostic device comprising: o a plurality of biological entities immobilized at distinct locations on a surface (or within the substrate), wherein the entities include predetermined DNA sequences or other biologically relevant molecules; o a set of agents conjugated to the biological entities, where each agent is specific to a known target molecule.

2. The diagnostic device of claim 1, where each biological entity is repeated at multiple distinct locations on the surface (or within the substrate) to create redundancy.

3. The diagnostic device of claim 1, where the agents are proteins, peptides, microRNAs, metabolites, lipids, small molecules, or phage-displayed antigens.

4. The diagnostic device of claim 1, further comprising: o a detection system that produces a detectable change in response to binding between the agents and their respective target molecules.

5. The diagnostic device of claim 4, where the detectable change is a colorimetric, fluorescent, or chemiluminescent signal.

6. The diagnostic device of claim 1, adapted for use in various assay formats including microarray, lateral flow, ELISA, or magnetic bead assays.

7. A method of producing the diagnostic device of claim 1, the method comprising: o immobilizing a plurality of biological entities at distinct locations on a surface (or within the substrate); o conjugating a set of agents to the biological entities.

8. The method of claim 7, further comprising repeating each biological entity at multiple distinct locations on the surface (or within the substrate) to create redundancy.

9. A method of using the diagnostic device of claim 1, the method comprising: o introducing a patient's sample onto the device; o detecting binding between the agents and any corresponding target molecules in the sample; o producing a detectable change in response to the binding.

10. The method of claim 9, further comprising using a smartphone application to capture an image of the detectable change and analyze the test results.I L A smartphone application for use with the diagnostic device of claim 1, the application comprising: o an image capture feature for capturing an image of the diagnostic device; o an image analysis feature for identifying changes on the device corresponding to binding between agents and their respective target molecules; o a result interpretation feature for correlating the changes with specific target molecules and producing a preliminary analysis of the test results.

12. The smartphone application of claim 11, further comprising a remote analysis feature for uploading the image and the preliminary analysis to a remote server for further evaluation.

13. The smartphone application of claim 11, further comprising data privacy and security features to protect the confidentiality and integrity of the patient's data.

14. A home testing kit comprising: o the device of any of the preceding claims,;o instructions for introducing a patient's sample onto the device and detecting the detectable change; o the smartphone application of claim 11 for capturing an image of the detectable change, analyzing the results, and providing a preliminary analysis.

15. The diagnostic device of claim 1, wherein the device is of a size and format suitable for home use.

16. The diagnostic device of claim 1, wherein the device includes a control sample or reference spot to validate the testing process.

17. The diagnostic device of claim 1, wherein the agents conjugated to the biological entities are labeled with a detectable marker.

18. The diagnostic device of claim 17, where the detectable marker is a color-changing compound, a fluorescent compound, or a chemiluminescent compound.

19. The diagnostic device of claim 1, wherein the device includes a sample application area that directs the sample towards the immobilized biological entities.

20. The diagnostic device of claim 1, wherein the immobilized biological entities include a series of oligonucleotides of known sequences.

21. The diagnostic device of claim 1, wherein the device is produced using spotting techniques or in situ synthesis.

22. A method for manufacturing the diagnostic device of claim 1, comprising: o spotting or in situ synthesizing a plurality of biological entities at distinct locations on a surface (or within the substrate); o conjugating a set of agents to the biological entities; o repeating each biological entity at multiple distinct locations on the surface (or within the substrate) to create redundancy.

23. A method of using the diagnostic device of claim 1, comprising: o introducing a patient's sample onto the device; o detecting binding between the agents and any corresponding target molecules in the sample using a smartphone application; o correlating the detectable changes with specific target molecules and producing an analysis of the test results.

24. The smartphone application of claim 11, further comprising a machine learning algorithm to increase the accuracy and precision of image analysis and result interpretation.

25. The smartphone application of claim 11, further comprising a feature to share the analysis with healthcare providers or store the data for future reference.

26. The home testing kit of claim 14, wherein the kit further comprises a sample collection tool, such as a swab, a lancet, or a container for collecting biological samples.

27. The home testing kit of claim 14, wherein the instructions comprise written instructions, visual aids, or digital instructions accessed through the smartphone application.

28. The diagnostic device of claim 1, wherein the device is designed for testing a range of biological samples, including but not limited to, blood, saliva, urine, or tissue samples.

29. The diagnostic device of claim 1, wherein the device is configured for detecting a range of conditions or markers including, but not limited to, antibodies, infectious diseases, genetic diseases, pregnancy, allergies, or drug metabolites.

30. A method for sharing data from the smartphone application of claim 11 with healthcare providers, comprising encrypting the data, transmitting the encrypted data over a network, and decrypting the data for analysis by the healthcareproviders. The diagnostic device of claim 1, wherein the biological entities comprise DNA, RNA, microRNA, proteins, peptides, metabolites, lipids, or carbohydrates.

31. The diagnostic device of claim 1, wherein the biological entities are single-stranded or double-stranded nucleic acids.

32. The diagnostic device of claim 1, wherein the biological entities are synthetic or naturally derived.

33. The diagnostic device of claim 1, wherein the agents conjugated to the biological entities comprise proteins, peptides, nucleic acids, antibodies, antigens, enzymes, aptamers, or small molecules.

34. The diagnostic device of claim 1, wherein the agents conjugated to the biological entities are labeled with detectable markers such as radioactive isotopes, fluorescent compounds, enzymes, or colorimetric compounds.

35. The diagnostic device of claim 1, wherein the device is configured to detect the interaction between the biological entities and the agents in a direct, sandwich, or competitive assay format.

36. The diagnostic device of claim 1, wherein the device comprises a blocking agent to prevent non-specific binding.

37. The diagnostic device of claim 1, wherein the device includes a washing step to remove unbound agents.

38. A method for manufacturing the diagnostic device of claim 1, comprising: o immobilizing a plurality of biological entities at distinct locations on a surface (or within the substrate); o conjugating a set of agents to the biological entities using chemical, biological, or physical methods; o labeling the agents with a detectable marker; o including a control sample or reference spot to validate the testing process.

39. A method of using the diagnostic device of claim 1, comprising: o introducing a patient's sample onto the device; o incubating the sample to allow interaction between the agents and any corresponding target molecules in the sample; o detecting binding between the agents and the target molecules using a smartphone application; o correlating the detectable changes with specific target molecules and producing an analysis of the test results.

40. The diagnostic device of claim 1, wherein the device is adapted for use as a lateral flow assay.

41. The diagnostic device of claim 40, wherein the device comprises: o a sample pad for application of a biological sample; o a conjugate pad containing the agents conjugated to a detectable marker; o a reaction matrix comprising the immobilized biological entities; o an absorbent pad for drawing the sample through the device.

42. The diagnostic device of claim 40, wherein the device operates under capillary action.

43. The diagnostic device of claim 40, wherein the device is configured to detect the interaction between the biological entities and the agents via the lateral flow of a liquid sample.

44. A method for manufacturing the diagnostic device of claim 40, comprising: o preparing a sample pad for application of a biological sample; o preparing a conjugate pad and loading it with the agents conjugated to a detectable marker;o preparing a reaction matrix and immobilizing the biological entities onto the matrix; o assembling the sample pad, the conjugate pad, the reaction matrix, and an absorbent pad into a lateral flow device.

45. A method of using the diagnostic device of claim 41, comprising: o applying a patient's sample onto the sample pad; o allowing the sample to migrate through the device by capillary action; o observing a detectable change on the reaction matrix as a result of the interaction between the agents and any corresponding target molecules in the sample; o using a smartphone application (or other identification aid) to capture an image of the detectable change, analyzing the image, and providing a preliminary analysis of the test results.

46. The smartphone application of claim 11, adapted for use with the diagnostic device of claim 40, wherein the application includes a feature for capturing an image of the reaction matrix and identifying changes corresponding to the interaction between the agents and their respective target molecules.

47. The home testing kit of claim 14, wherein the diagnostic device is a lateral flow device of claim 40.