Development of a Mobile Image Processing Application for Quantitative Home Diagnostic Test Analysis

The client faces difficulties in enabling consumers to accurately interpret varying test result intensities, such as those related to neutralizing antibody tests, due to limitations of current binary or subjective methods. This challenge hampers user confidence, consistent result interpretation, and scalable deployment of at-home diagnostic solutions across diverse lighting conditions and device models.

A mid-size healthcare technology company specializing in developing diagnostic tools and user-friendly health monitoring applications aimed at consumers for at-home testing and health data management.

• Create a mobile application capable of capturing images of diagnostic test cassettes and accurately identifying the test result regions.
• Implement image processing algorithms to assess colour intensity of test strips and correlate the hue with the concentration of tested substances.
• Ensure the app is compatible across various mobile devices and operating systems, providing reliable performance in different lighting conditions.
• Enable users to store, review, and interpret their test results conveniently within the application.
• Design the solution in compliance with relevant medical device software standards to ensure safety and regulatory adherence.

• Automatic identification and segmentation of the test cassette within uploaded photos.
• Colorimetric analysis to quantify hue intensity of test stripes.
• Database functionality to allow users to store and review past test results.
• User onboarding and guidance to facilitate proper test photo capture.
• Compliance with medical device software standards and regulations.

• Camera module for image capture
• Secure local storage or cloud-based database for user data retention
• Optional integration with health data platforms or regulatory reporting systems

• App must reliably operate across a broad range of device models and lighting scenarios.
• Image processing algorithms should deliver results within 2 seconds per image.
• Application must adhere to medical device software regulations such as ISO 13485 and FDA standards where applicable.
• Ensure data privacy and security compliant with relevant data protection laws.

The development of this application is expected to significantly enhance user confidence in at-home diagnostic testing through accurate, quantitative result interpretation. It aims to facilitate widespread adoption of home testing, reduce user error, and improve health monitoring capabilities, ultimately contributing to better health outcomes and scalable deployment of diagnostic solutions across multiple markets.