Quidel’s Lyra Direct SARS-CoV-2 assay received Emergency Use Authorization and CE Mark for molecular detection of COVID-19

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On May 18, 2020, Quidel announced it had received Emergency Use Authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay from the FDA to allow direct sample processing. Under the new EUA, the Lyra Direct SARS-CoV-2 Assay no longer requires an up-front sample extraction.

The Lyra Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time.

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Source: Quidel
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