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FDA Issues Template to Guide, Streamline Authorization of Serial SARS-CoV-2 Tests

NEW YORK – The US Food and Drug Administration on Tuesday issued a new supplement template for developers of SARS-CoV-2 tests intended to be used serially for screening that includes recommendations designed to streamline the Emergency Use Authorization of such tests.

Specifically, the new template indicates that point-of-care tests or at-home tests that have demonstrated strong performance in symptomatic patients can be authorized for over-the-counter use without being validated in asymptomatic individuals prior to authorization.

The template could help drive development of SARS-CoV-2 serial tests, which some have touted as key to slowing transmission of the virus. While FDA has indicated its interest in authorizing such tests, many developers have been reluctant to invest in them in the absence of a clear template from the agency.

In a statement, the FDA said it "believes that evidence of a test's strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals."

The template, which applies to molecular and antigen tests to be used serial within testing programs and by individuals at home, recommends that developers pursuing serial testing in asymptomatic individuals test users twice over two to three days with at least 24 hours and no more than 36 hours between tests.

Test developers may generate validation data in symptomatic patients by testing them serially according to the guidelines. According to the template, FDA would consider authorizing tests for OTC use at-home and POC tests with a positive percent agreement of 80 percent or greater (compared to PCR) with 70 percent at the lower bound of the two-sided 95 percent confidence interval.

Weekly testing may be considered for higher-sensitivity molecular tests.

Serial tests with sensitivity below 80 percent in symptomatic patients may still receive authorization, but for these tests "clinical evaluation in an asymptomatic population would generally be expected prior to authorization of a screening claim, including for OTC use, for such tests," the template states.

Tests authorized for screening based on symptomatic data will have to be validated in asymptomatic patients within a certain timeframe. Tests that are not validated in asymptomatic patients and that do not show adequate performance in these patients may have their authorization revised or revoked, the FDA said.