The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19.
Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency.
Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA), and the FDA said its new reference panel provides developers access to this material.
The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It 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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH). “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,” Shuren added. “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 agency recently warned that the ID NOW COVID-19 rapid diagnostic test made by Abbott (NYSE:ABT) may return false-negative results. The company countered that the test works better on specimens collected soon after patients begin showing symptoms and should not be used with chemical reagents normally used with tests that take longer to process.
The FDA said it has provided similar reference panels to assist industry in developing tests for other infectious diseases, including the Zika virus.