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How the FDA says it has worked to help the development of COVID-19 tests

Posted at 12:36 PM, Mar 30, 2020

CLEVELAND — With COVID-19 in limited supply and some test results taking several days to come in, many have called on their government to come up with more tests, and tests that deliver results faster.

Due to the demand for COVID-19 tests, the U.S. Food and Drug Administration said it has been providing “unprecedented flexibility” to laboratories and manufacturers to enable them to develop and offer the tests across the country.

While the FDA says its role is not to develop the tests or decide which test a healthcare provider uses, it is up to them to determine if the tests developed by labs and manufacturers are able to provide accurate, reliable results, as tests that show false results can contribute to the spread of COVID-19.

The first step of the process is the actual development of the test. Typically the Centers for Disease Control and Prevention is the first developer of a diagnostic test since it has the first access to viral samples—an important factor in confirming that the test is accurate. The CDC, with help from the FDA, found a manufacturer for the tests so it could be distributed to other health labs, according to the FDA.

In February, the COVID-19 viral samples became commercially available to the private sector test developers so they could confirm the accuracy of their tests, which typically takes two to three days, the FDA said.

Since January, the FDA has worked with more than 230 test developers. Since then, 20 FDA emergency authorizations have been granted and more than 100 labs have notified the FDA that they have been using their own tests, according to the administration.

The FDA said it has changed its policy amid the COVID-19 pandemic to “empower states to take responsibility for tests developed and used by laboratories in their states without FDA review,” but said for at least the first week, many laboratories either didn’t have a test or didn’t have the viral samples to check the accuracy of their tests.

The FDA said that in the future, making viral samples available earlier to commercial developers is the key factor in deploying tests quickly.

As the COVID-19 pandemic continues to develop, so do more tests for the virus. As more labs and manufactures work on the test, the more accurate they will become and the more advanced they will be, hopefully providing quicker, more accurate results, helping the fight against COVID-19.

In the meantime, facilities in Northeast Ohio such as the Cleveland Clinic and University Hospitals have strategized how to administer the limited supply of tests they have, announcing the prioritization of testing to first responders, including law enforcement, police, EMS and fire personnel.

RELATED: University Hopsitals, Cleveland Clinic prioritizing COVID-19 testing for first responders

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