DiaSorin receives FDA clearance for flu A/B and RSV test

Sept. 9, 2020

DiaSorin Molecular announced that it has received FDA Clearance for its Simplexa Flu A/B & RSV Direct Gen II kit, according to a press release.

The Simplexa Flu A/B & RSV Direct Gen II assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2,influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV), the company said.

Viral infections caused by Flu A, Flu B, RSV and SARS-CoV-2 have similar clinical presentations, however, treatment options are different, making it important to differentiate, DiaSorin noted. The accurate diagnosis of the virus causing the infection can have major implications for the management of therapeutic regimens, infection control and community mitigation efforts.

According to DiaSorin Molecular, the latest-generation Simplexa Flu A/B & RSV Direct Gen II kit delivers continued comprehensive strain coverage and accurate detection in an efficient and trusted sample-to-answer format that does not require extraction. Collectively, over 100 Flu A, Flu B and RSV strains have been validated, including the 2020/2021 influenza vaccine strains. The Simplexa Flu A/B & RSV Direct Gen II assay is designed for use with the LIAISON MDX instrument.

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