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Home » FDA says reference panel validation must be conducted on same system as cited in EUA
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FDA says reference panel validation must be conducted on same system as cited in EUA

Oct. 28, 2020
By Mark McCarty
Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).
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