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.
