The FDA said the panel is an independent performance validation step for SARS-CoV-2 tests that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers interacting with the FDA through the agency’s pre-Emergency Use Authorization process.
The reference panel “will provide test developers with well-characterized reagents to compare the performance of different molecular diagnostic tests under the same conditions,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “We are continuously evaluating our policies and approaches on diagnostic tests during this pandemic, including addressing poorly performing tests.”
Earlier this month, the FDA updated its requirements for molecular diagnostic developers seeking Emergency Use Authorization for COVID-19 tests to include the use of actual positive specimens.