FDA has issued an emergency use authorization to Illumina, San Diego, for its CovidSeq test, a high-throughput, sequencing-based, in vitro diagnostic workflow enabling the detection of SARS-CoV-2. The end-to-end workflow extends the options available for labs to scale diagnostic testing.


Francis deSouza, Illumina.

CovidSeq uses upper respiratory specimens, typically collected via a nasopharyngeal or oropharyngeal swab. The test is performed on Illumina’s NovaSeq 6000 sequencing system, and delivers test results in 24 hours. The differentiated diagnostic design includes 98 amplicons that target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity. CovidSeq is currently available to a limited number of early-access sites and is expected to be more broadly available this summer.

Leveraging the S4 flow cell of the NovaSeq 6000 instrument, the workflow accommodates up to 3,072 samples per run, and includes steps for viral RNA extraction, RNA-to-cDNA conversion, polymerase chain reaction, library preparation, sequencing, and report generation. Key components leveraged to perform testing include the NovaSeq 6000, Illumina’s Tagmentation library preparation technology, and the Dragen CovidSeq test pipeline for rapid reporting.

“CovidSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the covid-19 pandemic,” says Francis deSouza, chief executive officer of Illumina. “Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school.”

For more information, visit Illumina.