The Clock is Ticking to Deploy Rapid Antigen Tests Before They Expire: A Practical Guide for States and Partners

Rapid antigen tests are particularly effective at identifying likely contagious individuals within minutes so they can avoid spreading the virus to others. Unlike the standard PCR tests performed with invasive nasopharyngeal swabs, many rapid tests use shallow anterior nasal swabs that are effective and allow people to self-administer them.

While there is widespread support for rapid testing across the United States, several regulatory barriers have limited the ability of organizations and individuals to acquire and use these tests, resulting in many unused and expiring rapid tests.

Below are several ways for states to use these tests before they go to waste. These strategies can enable states to expand crucial testing efforts alongside the ongoing vaccine rollout.

How Can Tests Be More Readily Used?

Offer statewide CLIA waivers. Rapid antigen tests in the United States require organizations to obtain authorization to perform them through CLIA waivers. Several states such as Texas have set up umbrella CLIA waivers through a central approved site. Coverage under blanket CLIA waivers would quickly increase the number of facilities that could use expiring rapid tests.

Provide clarity on asymptomatic use. Emergency use authorization for rapid tests was initially granted for symptomatic use, leading to confusion about whether tests may be used for asymptomatic people. However, recently updated guidance from the CDC and FDA encourages responsible efforts to test asymptomatic individuals. And the FDA just granted new approvals for over-the-counter home rapid tests for asymptomatic individuals. Communications from states and the federal government should consistently and clearly encourage frequent testing (i.e., 2 to 3 times per week). Because a large proportion of Covid-19 virus transmission is from individuals without symptoms, California, for example, has tested individuals with or without symptoms as part of its pandemic control strategy. The presence of symptoms should be removed as a requirement for testing and for insurance coverage of tests.

Leverage rapid tests for surveillance testing. To expand available testing capacity, rapid tests from manufacturers that do not yet have FDA approval could potentially be used for surveillance testing, which is population-level testing not regulated by the FDA. Although individual results cannot be reported directly from this type of testing, those with positive or inconclusive results can be connected with confirmatory testing.

Ensure testing is encouraged, not penalized. Some institutions have been hesitant to test out of fear that spikes in positive results could lead to negative consequences like having to close facilities. Policies should be re-evaluated to ensure that institutions are rewarded for testing, not unfairly penalized. In addition, organizations that have access to rapid tests should be accountable for their use and follow through on offering them to vulnerable populations like incarcerated individuals.

Create volunteer “startup” teams. To help support public health departments that are already stretched thin, academic or nonprofit organizations with relevant expertise could provide guidance and training to help implement rapid testing programs at new sites. Similar to the Safely Opening Schools program in California, these “startup" teams could utilize national or state-level help centers to guide organizations through logistical challenges like:

• Procuring free or inexpensive tests from the government or reputable vendors.
• Determining appropriate testing frequency.
• Recruiting and training supporters to perform testing.
• Building local public buy in.
• Educating people on interpreting results.
• Connecting people with confirmatory testing.
• Organizing wraparound services to help individuals quarantine or isolate and protect them from negative financial consequences if they test positive.
• Ensuring that results are reported appropriately to health agencies.

Federal grant opportunities like those through the U.S. Department of Defense and the National Institutes of Health can help accelerate efforts to establish such communities of practice and facilitate testing programs in various settings.

Mobilize medical reserve corps and scientists. States can leverage medical and non-medical volunteer programs like the Medical Reserve Corps or the Covid-19 National Scientist Volunteer Database to help establish and run testing programs. To build on these efforts, states or the federal government could institute a “grand scientist duty” analogous to grand jury duty to recruit scientists and academics into a fixed period of public service during the pandemic to assist with rapid testing efforts. Major employers routinely pay salaries for employees who are called to jury duty and could do the same for those who volunteer for this important civil service program.    

Leverage digital tools to facilitate public health reporting and inventory management. Rapid test results have been underreported, hindering efforts to understand infection rates. A recent national survey found that most individuals want to report results, but the process isn’t easy.

Digital tools built by the CDC, in partnership with the U.S. Digital Service, like SimpleReport, can help simplify reporting to public health agencies. While SimpleReport is available only in Arizona and Florida, states can request access to it. While one rapid test manufacturer extended the expiration date, a powerful and user-friendly inventory management system could help avoid confusion and prevent unnecessary waste.

Move tests where they are needed most. An online marketplace and test distribution partners could help move tests to locations most in need before they expire. The Online Marketplace developed by Feeding America is a potential model. Small businesses like restaurants could apply for free or low-cost tests for employees and patrons to help scale up access to rapid testing.

Where Can Testing Best Be Utilized?

Community sites. Rapid response testing vehicles may be an effective way to deploy testing, as if they were ice cream trucks or mobile libraries, supplied instead with free test kits, guidance and isolation support. These testing vehicles could be placed at central locations like transit centers or malls. A model example of this can be found in Liverpool, U.K.

Workplaces, restaurants, schools and other communal settings. Engaging people where they go is another way to make rapid testing more accessible. For example, because masks need to be removed to eat and drink, rapid tests could be offered to restaurant patrons and employees to mitigate the added risks they face.

Higher education institutions are also uniquely positioned to facilitate rapid testing programs. The University of California, Davis “bubble” has become a model for large-scale community-based testing. Other large communal settings such as schools, nursing homes and correctional facilities could adopt a similar approach and should establish or update policies to implement frequent testing.

Airports and other travel hubs. Taking steps to make travel safer is essential for encouraging economic recovery. State and federal governments could assist transportation providers by offering free or subsidized rapid tests and guidance for this purpose to ease the burden on already hard-hit industries and travelers.

Increased access to rapid tests would enable workplaces, schools and communities to help people realize they are likely contagious before they unknowingly expose others. The time to act is now to ensure that no rapid tests go to waste and that testing can be scaled up appropriately to avoid future shortages. Along with vaccinations and other public health measures, widespread access to frequent rapid testing can help everyday people take back control of their lives to end the pandemic as soon as possible.

Editor's note: The piece was updated to reflect the Federal Drug Administration's latest action to authorize the use of rapid tests for asymptomatic individuals.