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 primer and probe sets 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. Up to 3072 results can be processed in 12 hours on the NovaSeq 6000 System using two NovaSeq 6000 S4 Reagent Kits with the Xp workflow.
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, coupled with the Illumina COVIDSeq Test and the DRAGEN COVIDSeq Test Pipeline for rapid clinical result reporting.
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 to monitor for errors.
The Illumina COVIDSeq Test is a next-generation sequencing (NGS) in vitro diagnostic test on the Illumina NovaSeq 6000 Sequencing System 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 Illumina NovaSeq 6000 Sequencing System and next-generation sequencing workflows as well as in vitro diagnostic procedures. COVIDSeq has not been FDA cleared or approved. This test is authorized by FDA under an EUA for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19.
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 DocumentBrochure | PDF < 1 MB
Fact Sheet for Healthcare Providers
Brochure | PDF < 1 MB
Automated processing for COVIDSeq™ workflow flexibility
Brochure | PDF < 1 MB
Index Adapters Pooling Guide Documentation
Illumina COVIDSeq Test Instructions for Use Documentation
Illumina DRAGEN COVIDSeq Test Pipeline Software Guide (IVD) Documentation
Illumina DRAGEN COVIDSeq Test App Guide (IVD) Documentation
Illumina Adapter Sequences Documentation
すべて Illumina COVIDSeq Test IVD Documentation Support すべて Illumina COVIDSeq Test IVD Support