510k clearance for Diasorin Simplexa COVID-19, Flu A/B, and RSV kit
The kit as broad coverage for influenza strains, emerging SARS-CoV-2 variants, and detection of both RSV subgroups A and B
The kit as broad coverage for influenza strains, emerging SARS-CoV-2 variants, and detection of both RSV subgroups A and B
The assay is designed to improve infection control in healthcare settings through the rapid identification of patients suspected of Candida auris colonization
The Simplexa™ SARS-CoV-2 Variants Direct assay aims to enable detection of four mutations associated with virus variants without requiring upfront RNA extraction
The test could be used to assess antibody response against the native spike protein of SARS-CoV-2 following COVID-19 vaccination
The Direct assay is validated on a wide range of specimen types, and can be run in parallel with the Simplexa Flu A/B & RSV Direct Gen II assay
Test to be integrated in over 5,000 DiaSorin analyzers, allowing physicians to differentiate between bacterial and viral infections
DiaSorin Molecular receives FDA clearance for Bordetella test
Simplexa™ GBS Direct molecular assay enables in vitro detection of Group B Streptococcus
Early identification of the disease will allow specific and extremely effective therapies for the treatment of patients