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Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

FDA News Release

For Immediate Release: September 15, 2020

Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA. The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA).

“By providing this panel to both commercial and laboratory test developers and evaluating the data we receive, we are able to gain valuable insight into the comparative performance of different authorized molecular diagnostic tests under the same conditions,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Reference panels can be used in many ways to support test development and authorization, but most importantly, they are a powerful tool in monitoring test performance and ensuring that Americans have access to diagnostics they can trust.”

The FDA began distributing the reference panel of samples in May and has provided it to more than 150 developers as a resource in the development and validation of accurate and reliable diagnostic tests. In order to ensure accuracy of test results using the reference panel, the FDA did not disclose the amount of viral material in the samples, resulting in a blind test for developers.

In the data published today, a lower LoD represents a test’s ability to detect a smaller amount of viral material in a given sample, signaling a more sensitive test. However, the data does not indicate how sensitive a particular test is, and, therefore, cannot be used by itself to determine whether to authorize a test or other regulatory action. Instead, the data gives laboratories, healthcare providers and patients a new resource on the relative performance of available tests to better inform which tests they choose to use. The FDA will continue to update the table as it receives additional results.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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