FDA offers reference panel to help validate COVID-19 diagnostics

2020 05 28 19 43 7671 Green Validate Rubber Stamp 400

The U.S. Food and Drug Administration (FDA) is now offering a reference panel that will help labs evaluate new molecular diagnostic tests for detection of SARS-CoV-2 genetic material.

The reference panel is a tool for evaluating whether a diagnostic test is accurate in the detection of SARS-CoV-2 RNA. It will be available to commercial and laboratory developers pursuing clearance through the agency's emergency use authorization (EUA) program, the agency said in a May 27 announcement. Developers with well-characterized reagents will now be able to compare different tests under the same conditions, the agency said. Reference tools have been helpful for evaluating diagnostics for other infectious diseases in the past, such as the Zika virus.

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