CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 25, 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable the 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).