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

Part of paid clinical trials in Newark, Delaware.

Sponsor
University of Delaware
Study ID
NCT06539728
Status
Not Yet Recruiting

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Conditions

  • Blindness
  • Vision, Low

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces — DIAGNOSTIC_TEST
    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.
  • Biomechanical Measurements — DIAGNOSTIC_TEST
    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.
  • Psychophysical Tasks — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Interaction with Coated Surfaces
    Participants in this arm will interact with the device and surface coated with the polymer-antibody coating. Subjects will be trained with a "positive" test and "negative" test prior to device testing. Subjects will then administer the synthetic saliva themselves and asked to determine if there was COVID antigen in the saliva by touching the device to compare the test patch to the positive and negative control patches. Subjects will also rate device usability.

Primary Outcome Measure

Success rate of identifying whether the model test is positive or negative [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of DelawareNewarkDelaware19711
Charles Dhong, PhD

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By research site
University of Delaware· Newark, DE

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