New & Noteworthy

October 2022

COVID-19 Test Kit


DiaSorin has received 510(k) clearance from the US FDA for the Simplexa COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens and is designed for use with the LIAISON MDX system. The Simplexa COVID-19 Direct assay does not require sample pre-treatment, enabling a faster time-to-result, ultimately allowing prompt decision making regarding isolation and treatment of infected patients. The test is highly specific for SARS-CoV-2 and targets two regions of the viral genome to minimize the impact of mutations on the kit performance with SARS-CoV-2 and potential variants of concern.

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