DiaSorin COVID-19 assay gets CE mark for saliva specimens

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January 2021—DiaSorin Molecular has attained CE marking for the addition of saliva specimens for use with the Simplexa COVID-19 Direct assay.

The Simplexa COVID-19 Direct assay is validated on a range of specimen types from the upper and lower respiratory tract and can be run in parallel with the Simplexa Flu A/B & RSV Direct Gen II assay. The assay is also CE marked for use with nasal swabs, nasopharyngeal swabs, nasal wash/aspirates, and bronchoalveolar lavages. It received EUA designation in March 2020.