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FDA Announces Updates To COVID-19 Diagnostic Test Policy

By Diagnostics World News Staff

March 17, 2020 | The U.S. Food and Drug Administration (FDA) announced an update to their February 2020 policy on diagnostic testing for coronavirus (COVID-19). This guidance was issued in order to accelerate the availability of novel COVID-19 diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency, according to the FDA.

In an official statement, Stephen Hahn, FDA’s Commissioner of Food and Drugs, laid out three key elements to the updated policy.

The first element allows states to take responsibility for diagnostic tests used by labs in their states. With this guidance in place, future tests and labs will deal directly with appropriate state authorities and not with the FDA.

The second is an expansion of whom previous guidance would apply to. While originally being applicable only to labs that are certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments (CLIA), the update states that the FDA “does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an EUA [Emergency Use Authorization], under certain circumstances,” according to Hahn.

The third element includes recommendations for test developers who wish to develop serological tests for COVID-19 use. Serological tests look for antibodies in a patient’s blood, focus on proteins made by the immune system when responding to an infection.

“We recognize that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis,” Hahn stated. “[H]owever, as stated in the updated guidance, the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.”

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