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23rd September 2020  Editorial by: US Food and Drug Administration (US FDA)

Limit of Detection Data Released for FDA-EUA COVID-19 qPCR Kits

The FDA has published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

The tables show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel provided by the FDA.

The FDA provided these standardized samples, known as a reference panel, to test developers who are required to assess their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA). 

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Date Published: 23rd September 2020

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