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Illumina has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its sequencing-based Covid-19 diagnostic test. Illumina COVIDSeq test is a high-throughput, sequencing-based and in vitro diagnostic (IVD) workflow test that facilitates the detection of SARS-CoV-2. The sequencing-based diagnostic test, which uses upper respiratory specimens such as nasopharyngeal or oropharyngeal swab, offers sample receipt to result in 24 hours using the NovaSeq 6000 sequencing system. The differentiated diagnostic design is comprised of 98 amplicons, which target the full SARS-CoV-2 genome, enabling to create precise detection and high sensitivity.
Illumina is currently offering COVIDSeq test to a limited number of early access sites, and plans to increase the supply by summer. The workflow holds the capacity to accommodate up to 3,072 samples per NovaSeq run through leveraging the S4 flow cell. It is comprised of steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation.
FDA Letter of Approval:
