Distinguishing between persistent infection with the same viral strain and re-infection with a new viral strain in an individual with recurrent positive molecular test results for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Detection and identification of vaccine-escape SARS-CoV-2 variants with spike (S) gene variant of interest
Detection and identification of SARS-CoV-2 variants containing S gene variants of interest that reduce the efficacy of vaccine-induced antibodies, convalescent plasma, and/or monoclonal antibody therapy for COVID-19
Highlights
This test uses polymerase chain reaction (PCR) to amplify multiple severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genetic sequences covering 99.9% of the viral genome, followed by a next-generation sequencing assay with sequence analyses to determine the Pangolin lineage, Nextclade clade assignment, and alterations of the viral spike (S) protein-encoding codons in known SARS-CoV-2 RNA-positive respiratory tract specimens. Testing is more likely to be successful in positive specimens with PCR target cycle threshold (Ct) values of 30.0 or less, or transcription-mediated amplification generated relative light units (RLU) of 1200 or more.
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