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FDA Releases EUA Templates for Clinical Laboratories and Manufacturers Creating Tests for the Broad Screening of Asymptomatic Individuals

FDA maze of regulations

FDA outlines guidance for testing asymptomatic individuals and updates EUA templates for molecular diagnostics.

The US Food and Drug Administration (FDA) released updates to the molecular diagnostic emergency use authorization (EUA) templates for clinical laboratories and manufacturers on June 16, 2020. These changes outlined the steps for a test to be authorized for the broad screening of asymptomatic individuals and explained the FDA’s expectations for these tests. These updates also provided guidance on obtaining EUAs for pooled specimen test methods.

Jeffrey E. Shuren, MD, JD, Director of the Center for Devices and Radiological Health at the FDA, said in a statement, “The FDA has authorized molecular diagnostic tests for individuals suspected of having COVID-19 by their healthcare provider. Such individuals can be symptomatic, pre-symptomatic, or asymptomatic.” Shuren went on to say, “It has always been a health care provider’s discretion to test asymptomatic individuals when warranted. Using COVID-19 diagnostic tests in this way is not the same as using such tests as a broad screening tool.”

Shuren also explained the purpose of the June 16 updates: “The FDA outlined the steps for a test to be authorized for broad screening of asymptomatic individuals by publicly providing information in updated templates for test developers on the FDA’s expectations for how a test can be validated for screening of asymptomatic individuals.”

Additionally, the FDA concurrently released FAQs addressing the testing of asymptomatic individuals. 

“Given that testing asymptomatic individuals means testing a greater volume of patients, and a low prevalence may be more likely in an asymptomatic population, particularly if the population is at low risk for contracting COVID-19, developers may be interested in using pooling techniques in tests used for asymptomatic screening,” Shuren further elaborated in his June 16 statement. 

With this update, pooling was defined as a technique that allows a laboratory to mix several samples together in a “batch” or pooled sample and then test the pooled sample with a diagnostic test. “For example, four samples may be tested together, using only the resources needed for a single test,” according to the FDA. 

As of June 19, via its General FAQs, the FDA reported that no EUA-authorized SARS-CoV-2 diagnostic test had been authorized for use with sample pooling.

Related Resources:

FDA June 16 Statement for EUA Updates Affecting Asymptomatic Testing and Sample Pooling

FDA EUA Templates