The agency now will allow states to take responsibility for tests developed and used by labs in their states. States can set up a system to authorize tests, and labs will not be required to check with the FDA.
The FDA also will let commercial manufacturers distribute and labs use new commercially developed tests before the FDA grants them emergency use authorization, but those allowances will only be made in specific circumstances.
The agency said that many commercial manufacturers are developing tests to diagnose COVID-19 expecting to need an emergency use authorization, but they’ll be allowed to use the tests for up to 15 days before they are granted the authorization as long as they provide instructions for using the test and post data about test’ performance online.
The FDA granted emergency authorizations to Hologic and Laboratory Corporation of America March 16 for the use of their COVID-19 diagnostic tests.
The agency also said it will allow labs to use serological tests, which are those that measure the number of antibodies or proteins that are in the blood when the body is responding to a specific infection. Serological tests are less complex than molecular tests, and their effectiveness for diagnosing is limited, so they still aren’t allowed to be the sole basis to diagnose COVID-19.
The agency said it has engaged with more than 100 manufacturers of diagnostic tests since the end of January and has been providing them with guidance on how to submit proper emergency use requests.
“We urge state authorities and commercial developers to take all necessary steps to ensure the availability of accurate tests. Inaccurate diagnoses during a pandemic can impair prevention efforts and delay appropriate treatment for sick patients,” the agency stated.
Read the full news release here.
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