CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction. The assay allows for the in vitro qualitative differential detection of the mutations N501Y, E484K, E484Q, and L452R from nasopharyngeal and nasal swab specimens from individuals previously diagnosed with COVID-19. These mutations are present in potential variants of clinical interest including those that were isolated in the U.K. (B.1.1.7), South Africa (B.1.351), Brazil and 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 format consists of pre-aliquoted reagents that are ready for use and leverages direct amplification disc technology and the melting curve capabilities of the Liaison MDX.