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FDA Updates Template for SARS-CoV-2 Antigen Tests

NEW YORK – The US Food and Drug Administration on Monday said it has updated its template for the development of rapid antigen-based SARS-CoV-2 tests.

The template, which is intended to guide test developers, includes current recommendations from the FDA concerning data and information that should be submitted to the agency to support Emergency Use Authorization applications for tests to detect a SARS-CoV-2 antigen. Included in the update are recommendations related to studies that support claims for screening asymptomatic individuals and multiplex antigen tests, FDA said.

Other recommendations include validation studies covering a test's limit of detection, cross reactivity, microbial interference, specimen stability, clinical evaluation, and other performance data.

The FDA also said in its template that antigen tests for the coronavirus should have a minimum sensitivity of 80 percent for all sample types submitted, although it noted, "Strategies for serial testing with less sensitive tests, such as 70 percent sensitivity, could increase overall sensitivity and be considered cumulatively rather than based on one-time testing."

If a test is intended for point-of-care use, the EUA submission should include data that demonstrates non-laboratory personnel can use the test accurately, while claims that the test can be used for asymptomatic individuals should include a clinical study in the intended population that compares results from the submitted assay with a comparator assay for each patient enrolled in the study.

EUA submissions for multianalyte respiratory panels, should contain analytical and clinical evaluations for each target analyte included in the panel, the agency said.

It noted that the template is a roadmap to help test developers provide the validation data and other information needed for an EUA evaluation, "but alternative approaches can be used."

To date, FDA has issued EUAs for seven rapid antigen tests for detecting SARS-CoV-2.