A new reference panel being offered by the U.S. Food and Drug Administration (FDA) proposes an additional, independent validation step to guarantee the quality of COVID-19 diagnostic tests.
Since COVID-19 reached U.S. shores earlier this year, many tests have arisen to detect its viral cause: SARS-CoV-2. Nucleic acid tests confirm infection through the detection of SARS-CoV-2’s genetic material. The FDA’s new reference panel provides developers access to that material, to guarantee the test works in the first place. However, the panel is meant for diagnostic tests being used for clinical, not research, purposes. Commercial and laboratory developers can access the panel if they are already interacting with the FDA as part of its pre-emergency use authorization process.
With more than 1,700,000 now infected with COVID-19 in the United States, according to the latest figures from Johns Hopkins University, such tests are more important than ever.
“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “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. 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.”
The FDA notes that reference panels help in quality control, validation of new assays, test calibration, and monitoring of assay performance. Most recently, they aided diagnostic tests and serological tests during the Zika virus outbreak.