The FDA addresses concerns of unreliable tests by providing a new tool to support their evaluation of SARS-CoV-2 diagnostic tests.
On May 27, 2020, the FDA notified clinical laboratory and commercial test developers in a press release that it is providing a SARS-CoV-2 reference panel for test developers to use while developing and validating tests.
The FDA described this tool in their press release: “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 released a requirement May 13, 2020, that real patient samples be used during validations (See: Update to COVID-19 Molecular Diagnostics Specimen Requirements) in an attempt to improve the quality of diagnostic testing.
“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,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH) said in the announcement. “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.”