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US FDA grants 510(k) clearance for DiaSorin’s Covid-19 Direct kit

September 14, 2022

The US Food and Drug Administration (FDA) has granted 510(k) clearance for DiaSorin’s Simplexa COVID-19 Direct kit.

The Simplexa COVID-19 Direct kit has been designed for detecting the SARS-CoV-2 virus directly from nasopharyngeal or nasal swab samples.

It is developed for use on the LIAISON MDX platform and can run directly through the direct amplification disc (DAD).

The Covid-19 molecular assay targets the ORF1 ab and S gene regions of the SARS-CoV-2 genome to reduce the impact of mutations on the performance of the kit on the virus as well as potential variants of concern.

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