Policy & Regulation
FDA reports availability of new tool to help develop and evaluate diagnostic tests for SARS-CoV-2 infection
28 May 2020 -

The US Food and Drug Administration (FDA) on Wednesday launched a SARS-CoV-2 reference panel in aid of commercial and laboratory developers who are interacting with the agency through its pre-emergency use authorization (EUA) process.

SARS-CoV-2 is the virus that causes COVID-19.

The agency explained that reference panels help ensure the quality of tests, validation of new assays, test calibration, and monitoring of assay performance. 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.

Nucleic acid tests identify infection by confirming the presence of a virus' genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. These types of reference panels have proven to be an invaluable resource in the development of accurate, reliable and validated diagnostic tests for detecting infectious diseases.

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