Executive Summary

On March 24, 2022, the Consortia for Improving Medicine with Innovation and Technology (CIMIT), on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB)’s Rapid Acceleration of Diagnostics (RADx®) Tech program, hosted a listening session to solicit input on the accessibility challenges of current at-home COVID-19 tests and potential improvements for these products. The session brought together leaders from organizations who represent communities in need of accessible tests, such as the American Council for the Blind (ACB), the National Disability Rights Network, the American Foundation for the Blind (AFB), National Federation of the Blind (NFB), the World Institute on Disability, the American Geriatrics Society (AGS), and the Alliance on Aging and Vision Loss, along with experts from government agencies including the National Council on Disability (NCD), the U.S. Access Board, the National Institutes of Health (NIH), the Administration for Community Living (ACL), the Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA). The listening session was held virtually and used ASL interpreters and live transcribers to accommodate all attendees. The goals of the listening session were to: 1) understand challenges to the accessibility of at-home tests, 2) discuss potential improvements, including their potential timescale, and 3) open lines of communication for ongoing discussion.

The listening session featured remarks from Bruce Tromberg, Ph.D., the Director of NIBIB; Jill Heemskerk, Ph.D., Deputy Director of  NIBIB; Mike Dempsey, Entrepreneur in Residence at CIMIT; and Anthony (Tony) Coelho, disability advocate and lead author of the Americans with Disabilities Act. Participants divided into breakout groups, with the objective to discuss the ongoing difficulties and potential improvements for at-home COVID-19 tests within three focus areas: 1) individuals who are blind or low-vision, 2) individuals with fine motor skill difficulties, and 3) older adults. The feedback from each group was then presented to the entire group so that specific priorities and shared observations could be identified. The feedback and takeaways from the breakout groups are summarized below.

Across the breakout groups, there were shared observations and suggestions that could potentially improve the experience of all COVID-19 test users.

Need for More Intuitive Test Packaging:

• Packaging lacks orientation indicators to direct users on how to open
  • Tabs or other tactile markers could guide users on the correct ends to open and the sequence for opening materials
• Packaging lacks scannable elements, such as a QR code or RFID chip, that connect to mobile applications and online guidance
  • Embedding elements that can open a webpage or mobile application would be particularly useful to those who use assistive technology 

Need for Clearer Instructions:

• Instructions are in small text and have limited language options
  • Additional language options could be provided in the printed Instructions for Use (IFUs) or be accessed online
• Instructions often lack simple, step-by-step visual depictions of the testing process
  • A link to a video demonstration of a test could improve the user’s ability to correctly administer the test

Need for Easier to Maneuver Test Components:

• Nasal swabs lack indicators for how deep they should be inserted into the nasal cavity
  • Instructions on the depth of the swab, such as mark on the swab itself, as well as the collection motion (swirl around the nostril vs. swirl the swab), would be helpful
• Test components are small and can be difficult to manipulate correctly
  • Larger components could be easier to grab and easier to view
  • Dispensing the correct number of drops into the small sample window was particularly difficult for some users
• Users often accidentally damage or contaminate test components during their first attempt of the test
  • Inclusion of a sample components or other means to “practice” test taking could reduce contamination

Need for More Descriptive Results:

• Most tests lack a clear readout of the test result, such as “positive” or “negative”
  • An image or word-based readout could reduce user confusion on results
  • Only a few tests have smartphone applications that can assist the user with reading or understanding the test result
• Most tests lack a non-visual means of interpreting results
  • Tactile or audial indicators could improve the user’s ability to interpret their test result

The breakout groups also identified certain aspects of current COVID-19 tests that are particularly challenging to those within a specific community.

Blind or Low Vision Breakout Group:

• While both blind and low vision test takers experience challenges with current at-home tests, their needs vary and they may require unique solutions (e.g., Braille instructions may help those who are blind, but may not be readable by individuals with low vision)

• Test instructions and components often lack high-contrast color options, which makes discerning different colors more challenging for test takers who are low vision

• Braille instructions are not included in the test kits and digital instructions are often incompatible with screen reader technology

• Few tests work with assistive technology, such as smartphone apps, which could greatly increase the user’s ability of taking and interpreting a test correctly

Fine Motor Skill Difficulties Breakout Group:

• The test and component packaging can be difficult to open for those with dexterity problems; in particular, the test tube caps can be very difficult to navigate

• The small size of test components relevant to the user’s hands presents a challenge and sometimes the testing process could cause pain, especially when users must squeeze the test tube or sample dropper

• The number of complex steps outlined in the instructions made participants anxious and hesitant to perform the tests

Older Adults Breakout Group:

• Instructions are often misinterpreted without a clear walkthrough of the procedure

• Tests that require the use of a smartphone application or direct users to additional guidance online (e.g., test taking videos) can pose additional challenges for older adults

The listening session concluded with a discussion among participants to identify means of improving both current and future COVID-19 tests. During the discussion, participants shared the following observations:

• The effort to make COVID-19 tests more accessible represents an opportunity to inform future product accessibility standards

  • COVID-19 tests are not the only at-home medical devices that need to be made more accessible to those with disabilities

• There may not be a “one size fits all” solution for accessible COVID-19 tests

  • Different solutions may be necessary to improve accessibility for different groups

  • There will likely always be individuals who require assistance to complete an at-home COVID-19 test, but the goal is to make tests accessible for independent use to as many people as possible

• Current design and medical equipment standards do not specify the accessibility standards that should be considered for at-home medical products

  • An entirely new set of standards would need to clearly define the needs for different types of accessibility