Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

FDA News Release

• For Immediate Release: May 27, 2020

Today the U.S. Food and Drug Administration took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. The FDA’s reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests. Today’s reference panel will provide test developers with well-characterized reagents to compare the performance of different molecular diagnostic tests under the same conditions,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “We are continuously evaluating our policies and approaches on diagnostic tests during this pandemic, including addressing poorly performing tests. We are committed to remaining flexible and providing more resources to developers as necessary, based on our regulatory expertise, real-world experience, and data, in order to protect and promote public health.”

These types of reference panels have proven to be an invaluable resource in the development of accurate, reliable, and validated diagnostic tests for detecting infectious diseases. The FDA has provided similar tools to assist industry in developing tests for other infectious diseases. For example, since the Zika outbreak in 2015, through the collaborative work between CDRH and the Center for Biologics Evaluation and Research (CBER), the FDA has responded to the need to directly compare the performance of different diagnostic assays by developing and producing reference panels. This work resulted in the FDA making available first a Zika reference panel for molecular-based diagnostic tests, and then a panel of human plasma samples to support the regulatory evaluation of serological tests to detect recent Zika virus infection.

By providing this new tool to aid in the evaluation of diagnostic tests for SARS-CoV-2, the FDA continues its public health mandate in combatting this pandemic.

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.