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FDA: We’re constantly working on COVID testing options

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It’s been more than 200 days since the FDA authorized the first COVID-19 diagnostic test. In the months following, we have authorized over 200 more tests for COVID-19. The sheer volume and variety of available tests is a testament to the FDA’s support of innovative test design and our commitment to public health.
From molecular diagnostic tests to rapid antigen tests, to antibody tests, to tests run in a clinical lab, to tests run in emergency rooms, pharmacies and nursing homes (point-of-care, or POC, tests), to samples self-collected at home, the FDA has authorized a multitude of options. We have also been working with developers on tests that can be administered and results delivered entirely outside of a lab or health care setting, such as a patient’s home. 

While the FDA has not yet authorized tests that can be performed entirely at home, we recognize that expanded access to testing outside of a health care setting is crucial to supporting the efforts to address the pandemic. 

As part of our ongoing effort to encourage the development of these tests, we currently recommend diagnostics for COVID-19 used at home should perform with at least 80 percent sensitivity if ordered by a health care professional, and at least 90 percent sensitivity if purchased over-the-counter for one-time testing. When consumers take the test over-the-counter at home, the consumers wouldn’t be advised by a health care professional on what to do or if they need a second test. Americans will use those results and make decisions about quarantining further, or returning to work, school and their community. Therefore, accurate results are particularly important. 

FDA’s performance recommendations vary for different types of tests as the FDA takes into consideration technology, accessibility and speed of results. For example, trading off some accuracy for greater availability and faster results makes sense for POC and at-home tests, as reflected in our recommendations. 

We also consider the risks of inaccurate or false, results, including both the likelihood and the consequences of a false result and whether the user can perform the test and interpret the results accurately. The danger of a false-negative result for a diagnostic test—that is, the test saying you’re not infected with COVID-19 when in fact you are — could prove especially harmful during the COVID-19 pandemic. You might be falsely assured that your symptoms are just a summer cold. You go about your normal day and then put everyone you encounter at risk of infection.

However, health care professionals could review the results in combination with the patient’s symptoms, whether the patient has had a known exposure and other risk factors and use their clinical judgment to recommend additional testing if needed. FDA performance recommendations in our existing templates try to strike the right balance for public health for the respective scenarios. 

For example, FDA recommendations for diagnostic, prescription POC tests reflect the possibility of sensitivity performance as low as 80 percent due to the benefits of broader access and the mitigation of physician involvement, just as in the case of prescription home tests. By comparison, tests used in sophisticated laboratories generally have sensitivities above 95 percent. So far, the diagnostic POC tests we have seen or authorized, or those in the pipeline, and ones that may be candidates for home use generally perform above 80 percent sensitivity.

However, our recommendations are just that — recommendations. FDA is always open to alternative proposals from developers and will continue to consider those. More significant trade-offs in test accuracy may be appropriate where the need for availability and fast results is not being met. 

Yet, even in those circumstances, steps can be taken to protect consumers, including strategies to increase accuracy. For example, strategies for serial testing with less sensitive tests, such as 70 percent sensitivity, could increase overall sensitivity and be considered cumulatively rather than based on one-time testing. Any proposal for serial testing should generally include estimated manufacturing capabilities to ensure there will be a sufficient supply of tests. As with all requests for emergency use authorization (EUA), the FDA evaluates the totality of the evidence to determine whether the known and potential benefits of the device outweigh the known and potential risks, among other considerations. We welcome developers with alternative proposals to come to talk with us.

The FDA supports any testing proposal where, among other criteria, the benefits outweigh the risks based on sound science. We will continue to work with test developers and encourage those with novel testing ideas to reach out — by email or phone or during our weekly test developer town hall meetings. 

Jeffrey Shuren, M.D., J.D., is the director of the FDA’s Center for Devices and Radiological Health and Timothy Stenzel, M.D., is the director of the FDA’s Office of In Vitro Diagnostics and Radiological Health.

Tags COVID-19 testing Food and Drug Administration Medicine

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