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DiaSorin Molecular Simplexa SARS-CoV-2 Variants Direct Assay

DiaSorin Molecular has released the research-use-only Simplexa SARS-CoV-2 Variants Direct Assay to enable the detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants. The assay enables the in vitro qualitative differential detection of the mutations N501Y, E484K, E484Q, and L452R directly from nasopharyngeal and nasal swab specimens from individuals previously diagnosed with COVID-19, without requiring RNA extraction. These mutations are present in potential variants of clinical interest including those isolated in the United Kingdom (B.1.1.7), South Africa (B.1.351), Brazil/Japan (P.1 and P.2), New York (B.1.526/B.1.526.1), California (B.1.427/B.1.429), Nigeria (B.1.525) and India (B.1.617/B.1.617.1/ B.1.617.2/B.1.617.3). The kit consists of pre-aliquoted reagents and leverages Direct Amplification Disc technology and the melting curve capabilities of the DiaSorin Liaison MDx platform.