The Illumina COVIDSeq Test is the first NGS test approved for use under the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA). This amplicon-based NGS test includes 2019-nCoV primers designed to detect RNA from the SARS-CoV-2 virus in nasopharyngeal, oropharyngeal, and mid-turbinate nasal swabs from patients with signs and symptoms of infection who are suspected of COVID-19.
The Illumina COVIDSeq Test can be scaled up or down to accommodate different numbers of samples. 1536 to 3072 results can be processed in 12 hours on NovaSeq 6000 system using two SP or S4 reagent kits, respectively or 384 results in 12 hours using NextSeq 500/550/550Dx (in RUO mode) HO reagent kit.
The workflow includes steps for viral RNA extraction, RNA-to-cDNA conversion, PCR, library preparation, sequencing, analysis, and report generation. Key components include the high-throughput NovaSeq 6000 System or the NextSeq 500/550/550Dx (in RUO mode) Systems, coupled with the Illumina COVIDSeq Test and the DRAGEN COVIDSeq Test Pipeline or DRAGEN COVIDSeq Test App in BaseSpace Sequence Hub for rapid analysis.
The Illumina COVIDSeq Test leverages a modified version of the validated, publicly available ARTIC multiplex PCR protocol, with 98 amplicons designed to amplify SARS-CoV-2 virus-specific sequences, combined with proven Illumina sequencing technology. As a quality feature, an internal control consisting of 11 human mRNA targets is included in every sample.
The Illumina COVIDSeq Test is a Next-Generation Sequencing (NGS) in vitro diagnostic test on the Illumina NovaSeq 6000 Sequencing System, NextSeq 500 Sequencing System, NextSeq 550 Sequencing System, or NextSeq 550Dx Instrument intended for the qualitative detection of SARS-CoV-2 RNA from nasopharyngeal (NP) swabs, oropharyngeal (OP) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal aspirates, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate health authorities.Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations, patient history, and epidemiological information. The Illumina COVIDSeq Test is intended for use by qualified and trained clinical laboratory personnel specifically trained in the use of the NovaSeq 6000 Sequencing System, the NextSeq 500 Sequencing System, the NextSeq 550 Sequencing System, or the NextSeq 550Dx Instrument, as well as Next-Generation Sequencing workflows and in vitro diagnostic procedures. The Illumina COVIDSeq Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
For In Vitro Diagnostic Use.
Contact an Illumina representative for regional availability.
This document describes the step-by-step process of the workflow, from sample collection to data analysis and report generation, and lists the required materials and equipment.
View DocumentLearn more about instructor-led training on the Illumina COVIDSeq Test (EUA) workflow.
Contact UsIllumina DRAGEN COVIDSeq Test App Guide (IVD) Documentation
Index Adapters Pooling Guide Documentation
Illumina DRAGEN COVIDSeq Test Pipeline Software Guide (IVD) Documentation
Illumina Adapter Sequences Document Documentation
Illumina COVIDSeq Test Instructions for Use Documentation