NCT06539728

Validation of Texture Changing Coatings for Use in At-Home Rapid Tests

Validation of Texture-Changing Tactile Coatings for Potential Use in Accessible At-Home Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.

Detailed description

Current at-home COVID tests are not accessible to people with low vision or blindness. To interpret results, people with low vision or blindness may need a sighted assistant, an internet-based image recognition tool, or some other sort of powered implement. Instead of adapting to technologies developed for sighted people, investigators propose a new platform which provides a no-power tactile readout, i.e., a texture change, to interpret test results. Although COVID antigens are at relatively low concentrations in human saliva, by relying on surface chemistry effects, a relatively small amount of sample can be designed to cause a significant texture change. This project will develop a new class of antibody-conjugated polymers which, in a saliva sample, bind to COVID antigen. In conjunction, investigators will also develop a test surface designed to maximize tactile feedback upon antigen binding. Upon binding to the test surface, a COVID positive surface will feel distinctive from the negative control, like distinguishing between plastic and glass. To optimize polymer design and test surface design, investigators use a combination of materials characterization, mechanical testing, human testing, and computational techniques. The project culminates by having low vision or blind users test the device with synthetic saliva solutions containing COVID antigen, present as innocuous protein isolates. Subjects will receive synthetic saliva with and without COVID antigen, and using our platform, will be asked to determine if the synthetic saliva did contain the COVID antigen. As a platform, the technology is not limited to COVID, but could be adapted to either new variants or other use cases, such as pregnancy tests. Investigators expertise combines accessibility experts, synthetic chemists, human psychophysics, computational simulations, surface science, and mechanics. To maximize project success, the project includes people with visual impairments at all stages to ensure practicality.

Conditions

• Vision, Low
• Blindness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces	Participants will drop a saline solution with proteins onto the testing device. They will wait for it to dry and then report on the tactile sensation and overall feel of the surface. Feedback will include comparisons with the two reference surfaces. The primary goal is to determine the presence of mock COVID antigen in synthetic saliva using the device, which aligns with the goals of diagnostic testing.
DIAGNOSTIC_TEST	Biomechanical Measurements	Participants may have biomechanical measurements recorded, such as placing samples on a scale to measure downward force or using medical tape with a flexible wire to track finger motion. These measurements are likely aimed at objectively assessing how participants interact with the surfaces and their physical responses to tactile stimuli.
BEHAVIORAL	Psychophysical Tasks	Participants may alternatively be asked to perform standardized psychophysical tasks, such as Two Alternative Forced Choice tests, Odd-Man Out tests, or Magnitude Estimation tests. These tasks will provide structured comparisons and quantitative data on participants' perception and preferences regarding tactile qualities. The tasks are designed to evaluate participants' perception and preferences regarding tactile qualities, which involves behavioral responses to sensory stimuli.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-08-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study