Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539728
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Validation of Texture Changing Coatings for Use in At-Home Rapid Tests
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation of Texture-Changing Tactile Coatings for Potential Use in Accessible At-Home Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None